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MINISTRY OF
HEALTH OF VIETNAM
-------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No. 44/2025/TT-BYT
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Hanoi, November
22, 2025
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CIRCULAR
Providing regulations on the delegation of authority
to implement some tasks and handle some medical device-related administrative
procedures under the jurisdiction of the Ministry of Health and regulations on
templates of documents and reports on the management of medical devices
Pursuant to Law on Government Organization No.
63/2025/QH15;
Pursuant to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices amended by
Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree NO.
04/2025/ND-CP;
Pursuant to Decree No. 217/2025/ND-CP dated
August 05, 2025 of the Government on specialized inspection;
Pursuant to Decree No. 42/2025/ND-CP dated
February 27, 02 of the Government on function, tasks, powers and organizational
structures of the Ministry of Health of Vietnam;
At the request of the Director of the
Infrastructure and Medical Device Administration (IMDA),
The Minister of Health hereby promulgates a
Circular providing regulations on the delegation of authority to implement some
tasks and handle some medical device-related administrative procedures under
the jurisdiction of the Ministry of Health and regulations on templates of
documents and reports on the management of medical devices.
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This Circular provides for:
1. The delegation of implementation of some tasks
and handling of some medical device-related administrative procedures under the
jurisdiction of the Ministry of Health.
2. Templates of documents and reports on management
of medical devices as specified in clause 12 Article 70 of Decree No.
98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and
Decree No. 04/2025/ND-CP.
Article 2. Delegation of
authority to implement some tasks and handle some medical device-related
administrative procedures under the jurisdiction of the Ministry of Health to
the IMDA
1. Issuance of new marketing authorization numbers
of class C and class D medical devices as specified in clause 32, Article 32a
of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No.
96/2023/ND-CP and Decree No. 04/2025/ND-CP.
2. Inspection after issuance of marketing
authorization numbers of class C and class D medical devices as specified in
clause 3 and clause 4 clause 32 of Decree No. 98/2021/ND-CP amended by Decree
No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
3. Suspension of circulation of batches of
medical devices, termination of suspension of circulation of batches of medical
devices as specified in clause 3, Article 34 of Decree No. 98/2021/ND-CP
amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No.
04/2025/ND-CP.
4. Recall of batches of medical devices as
specified in clause 4 Article 34 of Decree No. 98/2021/ND-CP amended by Decree
No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
5. Issuance of documents on the permission or
prohibition of continued circulation of medical devices in accordance with the
provisions of Article 37 of Decree No. 98/2021/ND-CP amended by Decree No.
07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
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7. Issuance of medical device import license as
specified in Article 48 of Decree No. 98/2021/ND-CP amended by Decree No.
07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
8. Issuance, renewal and revocation of certificates
of free sale of medical devices as specified in Article 50 of Decree No.
98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and
Decree No. 04/2025/ND-CP.
9. Issuance, supplementation and revocation of
certificates of registration of inspection of medical devices as specified in
Article 56 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP,
Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
10. Decision on the handling of medical devices
that fail to meet requirements for inspection as specified in Article 58 of
Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No.
96/2023/ND-CP and Decree No. 04/2025/ND-CP.
11. Specialized inspection for organizations and
individuals engaged in the classification of medical devices; manufacturing,
circulation, trading, exporting, importing and supply of medical device
services; information and advertising of medical devices; management and use of
medical devices at medical facilities in accordance with the provisions of
Clause 1, Article 6 of Decree No. 217/2025/ND-CP.
Article 3. Templates of
documents and reports on management of medical devices
Templates of documents and reports serving the
management of medical devices as specified in clause 12 Article 70 of Decree
No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP
and Decree No. 04/2025/ND-CP are enclosed herewith:
1. Appendix I: Written declaration of, disclosure
of, statement of, notification of or request for issuance of marketing
authorization number, import license and certificate of free sale.
2. Appendix II: Personnel list.
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4. Appendix IV: Written commitment and request for
continued circulation of medical devices.
5. Appendix V: Letter of authorization.
6. Appendix VI: Confirmation of eligibility for
warranty.
7. Appendix VII: Technical document for medical
devices.
8. Appendix VIII: Report on receipt, dispatch,
inventory, use of medical devices, production materials, EQA reagents that
contain narcotics/precursors.
Article 4. Entry into force
1. This Circular comes into force from November 22,
2025.
2. Circular No. 19/2021/TT-BYT dated November 16,
2021 of the Minister of Health shall be invalid from the effective date of this
Circular.
Article 5. Transitional
provision
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2. For Letters of authorization and Confirmations
of eligibility for warranty of medical devices that are signed by the medical
device owner for issuance using the templates in Circular No. 19/2021/TT-BYT
amended by Circular No. 10/2023/TT-BYT before the effective date of this
Circular and are still valid, they may be used continuously.
Article 6. Organization of
implementation
Chief of the Ministry Office, Director of Department
of Personnel and Organization, Director of Department of Legal Affairs,
Director of IMDA, agencies, organizations and individuals are responsible for
the implementation of this Circular.
Any difficulties arising during the implementation
of this Circular should be reported to the Ministry of Health (via the IMDA)
for timely consideration and handling./.
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
APPENDIX I
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Template No. 01
Declaration of eligibility for production of
medical devices
Template No. 02
Declaration of applied standards of class A
medical devices
Template No. 03
Declaration of applied standards of class B
medical devices
Template No. 04
Request for issuance of new marketing authorization
numbers of class C and class D medical devices subject to national technical
regulations
Template No. 05
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Template No. 06
Request for issuance of new marketing
authorization numbers of class C and class D medical devices eligible for
quick issuance
Template No. 07
Request for issuance of new marketing
authorization numbers of class C and class D medical devices eligible for
emergency use authorization
Template No. 08
Request for issuance of new marketing
authorization numbers of other class C and class D medical devices
Template No. 09
Declaration of eligibility for trading of class
B, class C and class D medical devices
Template No. 10
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Template No. 11
Request for issuance of certificate of free sale
of class C and class D medical devices
Template No. 12
Notification of updated information in
application for declaration of eligibility for production of medical devices
Template No. 13
Notification of updated information in application
for declaration of applied standards of class A and class B medical devices
Template No. 14
Notification of updated information in marketing
authorization application of class C and class D medical devices
Template No. 15
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Template No. 16
Disclosure of planned medical device
advertising contents and formats
Template
No. 01
NAME OF
MANUFACTURER
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………
……1………(date)
..................., 20...
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OF ELIGIBILITY FOR PRODUCTION OF MEDICAL DEVICES
To: .............2...................
1. Name of manufacturing facility:
TIN: …………………………………………………………………..
Address of the head office: …….. 3
………………………………………………………
Address of the facility: ....................... 4…………………………………………...
Tel: ................................ ………….. Fax:
………………………..
Email: .......................................
Website (if any): …………..
2. Legal representative of the manufacturing
facility:
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ID card number/passport number: ………..date of issue:
……………………. Place of issue: ........................
Landline: .........………………. Mobile phone: ……………………
3. Medical devices produced by the manufacturing
facility:
No
Name of medical
device
Expected scale
(products per year)
1.
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Declaration of eligibility for production of medical
devices
Enclosures:
1.
ISO 13485 Certificate
□
2.
Documents regarding the system for monitoring and
managing the processes of exporting, importing, inventory and usage of raw
materials that are narcotics and precursors, as well as the processes of
exporting, importing and inventory of medical devices containing narcotics
and precursors, and the storage warehouse.
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We hereby commit that:
1. The declared information is accurate and legal according
to the regulations. We will wholly be responsible for any falsification and
will face penalties according to regulations of law.
2. We ensure the fulfillment and maintenance of
requirements declared during the process of operation.
3. Any changes related to the application for
declaration of eligibility for production of medical devices will be updated as
per regulations.
Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
__________________________
1 Geographic name
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3 The address written on the business
registration certificate
4 If it coincides with the registered
business address, state “at the headquarters”
Template
No. 02
FACILITY’S NAME
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………
……1………(date)
..................., 20...
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OF APPLIED STANDARDS OF CLASS A MEDICAL DEVICES
To: .............2...................
1. Name of the declaring facility:
..............................................................................
TIN or number of Licence for representative office
establishment: .................
Address: ……3………
...............................................................................
Landline: .. ......………………………….. Fax: ..
...................................
Email:
...........................................……… ...............................................
2. Legal representative of the facility:
Full name:
................................................................................................
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Landline: .........………………. Mobile phone:
...........................
3. Class A medical device:
Common medical devices4: □ or in vitro
diagnostic medical devices: □
Name of medical device5:
.....................................................................................
Trade name6 (if any):
.........................................................................
Global Medical Device Nomenclature - GMDN
code (if any): .................
Model: ..............................................................................................
Product code (if any):
............................................................................
Packing specification (if any):
....................................................................
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Name of manufacturing facility:
..................................................................................
Address of the manufacturing facility:
.............................................................................
Applied standards:
................................................................................
4. For medical device that contains narcotic or
precursor:
Name of narcotic/ precursor: …………………. Scientific
name: ……………
CAS Registry Number (CAS RN):
..................................................................................
Concentration and content of the narcotic or
precursor: ............................................
Total content of narcotics or precursors in a
smallest packing unit:
.........................................................................................................................
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The owner’s name:
.......................................................................................
Address of the owner of medical device:
..................................................................................
6. Information about warranty facility (if any):
Name of the facility:
................................................................................................
Address:
....................................................................................................
Landline: ....................... Mobile phone:
..........................
7. Number of declaration of eligibility for
domestic production of medical devices:…
.............................................................................................................
Declaration of applied standards of class A
medical devices
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1.
ISO 13485 Certificate
□
2.
Letter of authorization of the medical device
owner.
□
3.
Confirmation of eligibility for warranty
□
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Documentation of brief technical description of
the medical device in Vietnamese
□
5.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
□
6.
Technical documents in Vietnamese enclosed with documents
on materials, product safety, manufacturing process and clinical and
preclinical investigation reports including reports on the stability of IVD
reagents, calibrators and controls.
□
7.
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□
8.
Certificate of conformity with standards
□
9.
For a medical device domestically manufactured:
result of evaluating chemical, physical and microbiological parameters and
other parameters granted by a qualified facility according to the provisions
of law on conformity assessment or Certificate of quality assessment issued
by a competent authority of Vietnam for in vitro diagnostic medical devices
□
10.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
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11.
Template of label on the medical device
□
12.
Certificate of free sale for the imported medical
device
□
We hereby declare that:
1. The declared information is accurate and legal
according to the regulations. We will wholly be responsible for any
falsification and will face penalties according to regulations of law.
2. The quality of the medical device will be
ensured and the medical device will be circulated in accordance with the
declaration.
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Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or digital signature
__________________________
1 Geographic name
2 Department of Health of the
province/central-affiliated city where the facility is located
3 The address written on the business
registration certificate
4 A non-IVD medical device:
5 Name of the medical device in
Vietnamese written according to the intended use of the medical device, except
in cases where Vietnamese translation is not possible.
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Template
No. 03
FACILITY’S NAME
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………
……1………(date)
..................., 20...
DECLARATION
OF APPLIED STANDARDS OF CLASS B MEDICAL DEVICES
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1. Name of the declaring facility:
..............................................................................
TIN or number of Licence for representative office
establishment: .................
Address: ……3………
...............................................................................
Landline: .. ......………………………….. Fax: ..
...................................
Email:
...........................................………
...............................................
2. Legal representative of the facility:
Full name:
................................................................................................
ID card number/Passport number: ……. Date of issue:
……… Place of issue: .........................
Landline: .........………………. Mobile phone: ...........................
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Common medical devices4: □ or in vitro
diagnostic medical devices: □
Name of medical device 5:
.....................................................................................
Trade name6 (if any):
........................................................................
Global Medical Device Nomenclature - GMDN code (if
any): .................
Model:
..............................................................................................
Product code (if any):
............................................................................
Packing specification (if any):
....................................................................
Uses: ...................................................................................
Name of manufacturing facility:
..................................................................................
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Applied standards:
................................................................................
4. For medical device that contains narcotic or
precursor:
Name of narcotic/ precursor: ……………Scientific name:
………..……
CAS Registry Number (CAS RN):
..................................................................................
Concentration and content of the narcotic or
precursor: ............................................
Total content of narcotics and precursors in a
smallest packing unit: .....................
…………..................................................................................................
5. Information about the owner of the medical
device:
The owner’s name:
.......................................................................................
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6. Information about warranty facility (if any):
Name of the facility: ................................................................................................
Address:
....................................................................................................
Landline: ....................... Mobile phone:
..........................
7. Number of declaration of eligibility for
domestic production of medical device:…
.............................................................................................................
Declaration of applied standards of class B
medical devices
Enclosures:
1.
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□
2.
Letter of authorization of the medical device
owner.
□
3.
Confirmation of eligibility for warranty
□
4.
Documentation of brief technical description of
the medical device in Vietnamese
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5.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
□
6.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, manufacturing process and clinical and
preclinical investigation reports including reports on the stability of IVD
reagents, calibrators and controls.
□
7.
Standard version declared to be applied by the
medical device owner
□
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Certificate of conformity with standards
□
9.
For a medical device domestically manufactured:
result of evaluating chemical, physical and microbiological parameters and
other parameters granted by a qualified facility according to the provisions
of law on conformity assessment or Certificate of quality assessment issued
by a competent authority of Vietnam for in vitro diagnostic medical devices
□
10.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
□
11.
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□
12.
Certificate of free sale for the imported medical
device
□
We hereby declare that:
1. The declared information is accurate and legal according
to the regulations. We will wholly be responsible for any falsification
and will face penalties according to regulations of law.
2. The quality of the medical device will be
ensured and the medical device will be circulated in accordance with the
declaration.
3. Any changes related to the declaration will be
updated in accordance with regulations.
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Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or digital signature
__________________________
1 Geographic name
2 Department of Health of the
province/central-affiliated city where the facility is located
3 The address written on the business
registration certificate
4 A non-IVD medical device:
5 Name of the medical device in
Vietnamese written according to the intended use of the medical device, except
in cases where Vietnamese translation is not possible.
6 Trade name given by the medical
device owner.
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NAME OF
REGISTERING FACILITY
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………
……1………(date)
..................., 20...
WRITTEN REQUEST
for
issuance of new marketing authorization numbers of class C and class D medical
devices subject to national technical regulations
To: Infrastructure
and Medical Device Administration (IMDA)
1. Name of the registering facility:
..............................................................................
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Address:………. 2………..
.................................................................................
Tel: .........………………………………Fax:
.......................................
Email: ...........................................
..........................................................
2. Legal representative of the facility:
Full name:
................................................................................................
ID card number/Passport number: ………... Date of
issue: ………… Place of issue: .....................
Landline: .........………………. Mobile phone:
...........................
3. Medical device requiring marketing
authorization:
Name of the medical device: ......................................................................................
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Global Medical Device Nomenclature - GMDN code (if
any): .................
Model:
..............................................................................................
Product code (if any):
............................................................................
Packing specification (if any): ....................................................................
Type of medical device:
.....................................................................................
Uses:
...................................................................................
Name of manufacturing facility:
..................................................................................
Address of the manufacturing facility:
.............................................................................
4. Information about the owner of the medical
device:
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Address of the owner of medical device:
..................................................................................
5. Information about warranty facility (if any):
Name of the facility:
................................................................................................
Address:
....................................................................................................
Landline: ....................... Mobile phone:
..........................
6. Number of declaration of eligibility for
domestic production of medical device: ..
....................................................................................................................
7. Effective periods of documents contained in the
application 3:
- ISO 13485 Certificate: …………
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- Certificate of free sale for the imported medical
device: …………………………
Enclosures:
1.
ISO 13485 Certificate
□
2.
Letter of authorization of the medical device
owner.
□
3.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
□
4.
Certificate of free sale for the imported medical
device
□
5.
Common Submission Dossier Template (CSDT)
□
6.
Certificate of conformity with regulations
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
7.
Documentation of brief technical description of
the medical device in Vietnamese
□
8.
Technical documentation of functions and specifications
of the medical device promulgated by its owner
□
9.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and
manufacturing process and clinical and preclinical investigation reports
including reports on the stability of IVD reagents, calibrators and controls.
□
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
□
11.
Template of label on the medical device
□
12.
Certificate of medical device clinical trial
results issued by the competent authority in cases where clinical trials are
required by law
□
We hereby delares that:
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
2. The quality of the medical device will be
ensured and the medical device will be circulated in accordance with the
application.
3. Any changes related to the application will be
updated in accordance with regulations.
Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
__________________________
1 Geographic name
2 The address written on the business
registration certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Template
No. 05
NAME OF
REGISTERING FACILITY
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………
……1………(date)
..................., 20...
WRITTEN REQUEST
for issuance of new marketing authorization
numbers of medical devices of class C and class D medical devices that are
measuring instruments whose samples require approval as prescribed by the law
on measurement
To: Infrastructure and
Medical Device Administration (IMDA)
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
TIN or number of Licence for representative office
establishment: .................
Address:…………2………………………………………………………………..
Tel: .................................... ………Fax:
.......................................
Email: ...........................................
..........................................................
2. Legal representative of the facility:
Full name:
................................................................................................
ID card number/Passport number: ……. Date of issue:
…… Place of issue: ..................................
Landline: ....................... Mobile phone:
...........................
3. Medical device requiring marketing
authorization:
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Trade name (if any): .........................................................................
Global Medical Device Nomenclature - GMDN code (if
any): ................
Model:
..............................................................................................
Product code (if any):
............................................................................
Packing specification (if any):
....................................................................
Type of medical device
.....................................................................................
Uses:
...................................................................................
Name of manufacturing facility:
..................................................................................
Address of the manufacturing facility:
............................................................................
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
The owner’s name:
.......................................................................................
Address of the owner of medical device:
.................................................................................
5. Information about warranty facility (if any):
Name of the facility:
...............................................................................................
Address:
....................................................................................................
Landline: ....................... Mobile phone:
...........................
6. Number of declaration of eligibility for
domestic production of medical device: ..
7. Effective periods of documents contained in the
application 3:
- ISO 13485 Certificate: …………
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
- Certificate of free sale for the imported medical
device: …………………………
Enclosures:
1.
ISO 13485 Certificate
□
2.
Letter of authorization of the medical device
owner.
□
3.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
□
4.
Certificate of free sale for the imported medical
device
□
5.
Common Submission Dossier Template (CSDT)
□
6.
Decision on sample approval
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
7.
Documentation of brief technical description of
the medical device in Vietnamese
□
8.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
□
9.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and
manufacturing process and clinical and preclinical investigation reports
including reports on the stability of IVD reagents, calibrators and controls.
□
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
□
11.
Template of label on the medical device
□
12.
Certificate of medical device clinical trial
results issued by the competent authority in cases where clinical trials are
required by law
□
We hereby delares that:
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
2. The quality of the medical device will be
ensured and the medical device will be circulated in accordance with the
application.
3. Any changes related to the application will be
updated in accordance with regulations.
Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
__________________________
1 Geographic name
2 The address written on the business
registration certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Template
No. 06
NAME OF
REGISTERING FACILITY
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………
……1………(date)
..................., 20...
WRITTEN REQUEST
for issuance of new marketing authorization
numbers of class C and class D medical devices eligible for quick issuance
To: Infrastructure
and Medical Device Administration (IMDA)
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
TIN or number of Licence for representative office
establishment: .................
Address:……2…………..
.........................................................
Tel: .................................... ………Fax:
.......................................
Email: ...........................................
………………………………............
2. Legal representative of the facility:
Full name: ................................................................................................
ID card number/Passport number: ……. Date of issue:
…… Place of issue: ..................................
Landline: ....................... Mobile phone:
...........................
3. Medical device requiring marketing
authorization:
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Trade name (if any):
.........................................................................
Global Medical Device Nomenclature - GMDN code (if
any): ................
Model:
..............................................................................................
Product code (if any):
............................................................................
Packing specification (if any):
....................................................................
Type of medical device
.....................................................................................
Uses:
...................................................................................
Name of manufacturing facility:
..................................................................................
Address of the manufacturing facility: ............................................................................
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
The owner’s name:
.......................................................................................
Address of the owner of medical device:
.................................................................................
5. Information about warranty facility (if any):
Name of the facility:
...............................................................................................
Address:
....................................................................................................
Landline: ....................... Mobile phone:
...........................
6. Information about the circulation of the medical
device:
- Number of document:
....................................................................................
- Name of the issuing organization:
....................................................................................
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
- Expiry date:
.................................................................................
7. Number of declaration of eligibility for
domestic production of medical device: ..
.....................................................................................................................
8. Effective periods of documents contained in the
application3:
- ISO 13485 Certificate: …………
- Letter of authorization of the medical device
owner: ……………………………..
- Certificate of free sale for the imported medical
device: …………………………
Enclosures:
1.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
□
2.
Letter of authorization of the medical device
owner.
□
3.
Confirmation of eligibility for warranty
□
4.
Certificate of free sale for the imported medical
device
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
5.
Common Submission Dossier Template (CSDT)
□
6.
Certificate of quality assessment issued by a
competent authority of Vietnam for in vitro diagnostic medical devices
□
7.
Documentation of brief technical description of
the medical device in Vietnamese
□
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
□
9.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and
manufacturing process and clinical and preclinical investigation reports
including reports on the stability of IVD reagents, calibrators and controls.
□
10.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
□
11.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
□
We hereby delares that:
1. The declared information is accurate and legal
according to the regulations. We will wholly be responsible for any
falsification and will face penalties according to regulations of law.
2. The quality of the medical device will be
ensured and the medical device will be circulated in accordance with the
application.
3. Any changes related to the application will be
updated in accordance with regulations.
Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
__________________________
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
2 The address written on the business
registration certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
Template
No. 07
NAME OF
REGISTERING FACILITY
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………
……1………(date)
..................., 20...
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
for issuance of new marketing authorization
numbers of class C and class D medical devices eligible for emergency use
authorization
To: Infrastructure
and Medical Device Administration (IMDA)
1. Name of the registering facility: ..............................................................................
TIN or number of Licence for representative office
establishment: .................
Address:………. 2………..
.........................................................................
Tel: .................................... ………Fax:
.......................................
Email: ...........................................
…… ..................................................
2. Legal representative of the facility:
Full name: ................................................................................................
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Landline: ....................... Mobile phone:
..........................
3. Medical device requiring marketing
authorization:
Name of the medical device:
......................................................................................
Trade name (if any):
.........................................................................
Global Medical Device Nomenclature - GMDN code (if
any): ................
Model:
..............................................................................................
Product code (if any): ............................................................................
Packing specification (if any):
....................................................................
Type of medical device
......................................................................................
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Name of manufacturing facility:
..................................................................................
Address of the manufacturing facility: ............................................................................
4. Information about the owner of the medical
device:
The owner’s name:
.......................................................................................
Address of the owner of medical device:
.................................................................................
5. Information about warranty facility (if any):
Name of the facility:
...............................................................................................
Address:
....................................................................................................
Landline: ....................... Mobile phone:
...........................
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
- Number of document:
....................................................................................
- Name of the issuing organization:
....................................................................................
- Date of issue:
..............................................................................................
- Expiry date:
.................................................................................
- Links to the documents about the circulation and
permission for use of the medical device: .....
7. Number of declaration of eligibility for
domestic production of medical device:
....................................................................................................................
8. Effective periods of documents contained in the
application3:
- ISO 13485 Certificate: …………
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
- Certificate of free sale for the imported medical
device: …………………………
Enclosures:
1.
ISO 13485 Certificate
□
2.
Letter of authorization of the medical device
owner.
□
3.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
□
4.
CFS/MA or licence for emergency use authorization
for the imported medical device.
□
5.
Document containing links to the applicant for
issuance of marketing authorization numbers
□
6.
Common Submission Dossier Template (CSDT)
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
7.
Technology transfer contract
□
8.
Processing contract
□
9.
Certificate of product quality inspection or
assessment
□
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Documentation of brief technical description of
the medical device in Vietnamese
□
11.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
□
12.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and
manufacturing process and clinical and preclinical investigation reports
including reports on the stability of IVD reagents, calibrators and controls.
□
13.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
□
14.
Template of label on the medical device
□
15.
Certificate of medical device clinical trial
results issued by the competent authority in cases where clinical trials are required
by law
□
We hereby delares that:
1. The declared information is accurate and legal
according to the regulations. We will wholly be responsible for any
falsification and will face penalties according to regulations of law.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
3. Any changes related to the application will be
updated in accordance with regulations.
Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
__________________________
1 Geographic name
2 The address written on the business
registration certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
NAME OF
REGISTERING FACILITY
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………
……1………(date)
..................., 20...
WRITTEN REQUEST
for issuance of new marketing authorization
numbers of other class C and class D medical devices
To: Infrastructure
and Medical Device Administration (IMDA)
1. Name of the registering facility: …. .........................................................................
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Address:………. 2………..
.........................................................................
Tel: .................................... ………Fax:
.......................................
Email: ...........................................
…… ..................................................
2. Legal representative of the facility:
Full name: ................................................................................................
ID card number/Passport number: ……. Date of issue:
…… Place of issue: ..................................
Landline: ....................... Mobile phone:
...........................
3. Medical device requiring marketing
authorization:
Name of the medical device:
......................................................................................
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Global Medical Device Nomenclature - GMDN code (if
any): ................
Model:
..............................................................................................
Product code (if any):
............................................................................
Packing specification (if any):
....................................................................
Type of medical device
.....................................................................................
Uses:
...................................................................................
Name of manufacturing facility:
..................................................................................
Address of the manufacturing facility:
............................................................................
4. Information about the owner of the medical
device:
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Address of the owner of medical device:
.................................................................................
5. Information about warranty facility (if any):
Name of the facility:
...............................................................................................
Address:
....................................................................................................
Landline: ....................... Mobile phone:
...........................
6. Number of declaration of eligibility for
domestic production of medical device:
.............................................................................................................................
7. Effective periods of documents contained in the
application3:
- ISO 13485 Certificate: …………
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
- Certificate of free sale for the imported medical
device: …………………………
Enclosures:
1.
ISO 13485 Certificate
□
2.
Letter of authorization of the medical device
owner.
□
3.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
□
4.
Certificate of free sale for the imported medical
device
□
5.
Common Submission Dossier Template (CSDT)
□
6.
The CSDT inspection record
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
7.
Certificate of quality assessment issued by a
competent authority of Vietnam for in vitro diagnostic medical devices
□
8.
Certificate of analysis of composition and
content of substances with antibacterial activity; assessment form for
bio-efficacy of products for chemicals and preparations serving the only
purpose of sterilization.
□
9.
Documentation of brief technical description of
the medical device in Vietnamese
□
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Technical documentation of functions and
specifications of the medical device promulgated by its owner
□
11.
Technical documents in Vietnamese enclosed with
documents on materials, product safety, product quality control and
manufacturing process and clinical and preclinical investigation reports
including reports on the stability of IVD reagents, calibrators and controls.
□
12.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
□
13.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
□
14.
Certificate of medical device clinical trial
results issued by the competent authority in cases where clinical trials are
required by law
□
We hereby declare that:
1. The declared information is accurate and legal
according to the regulations. We will wholly be responsible for any
falsification and will face penalties according to regulations of law.
2. The quality of the medical device will be
ensured and the medical device will be circulated in accordance with the
application.
3. Any changes related to the application will be
updated in accordance with regulations.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
__________________________
1 Geographic name
2 The address written on the business
registration certificate
3 In case of multiple documents: Specify
expiry date of the document whose effective period is shortest. In
case of a document whose effective period is not specified, write “indefinite”.
Template
No. 09
FACILITY’S NAME
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
……1………(date)
..................., 20...
DECLARATION
of eligibility for trading of class b, class c and class d
medical devices
To: .............2...................
1. Name of the facility:
......................................................................................................
TIN: ………………………………………………………………………
Address:………3………………………………………
Transaction office (if any): …………………………………………………..
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Full name: ………………………………………………………………………..
ID card number/Passport number: ……. Date of issue:
……… Place of issue: ……………………….
Landline: ............................... Mobile
phone: ……………………
3. Technical staff of the business facility4:
Full name: ………………………………………………………………………..
ID card number/Passport number: ……. Date of issue:
……… Place of issue: ……………………….
Professional qualification: ……………………………………………………………
4. The list of medical devices/groups of medical
devices traded by the facility:
............................................................................................................................
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
............................................................................................................................
............................................................................................................................
Declaration of eligibility for trading of
medical devices
Enclosures:
1.
Personnel list
□
2.
Records of storage warehouse for medical devices
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
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3.
Records of means of transport of medical devices
□
4.
Documentary evidence of the storage warehouse and
system for monitoring and managing the exporting, importing and
inventory process of medical devices containing narcotics or precursors
□
We hereby declare that:
1. The declared information is accurate and legal
according to the regulations. We will wholly be responsible for any
falsification and will face penalties according to regulations of law.
2. The quality of the medical device will be
ensured and the medical device will be circulated in accordance with the
declaration.
...
...
...
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Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
__________________________
1 Geographic name
2 Department of Health of the
province/central-affiliated city where the facility is located
3 The address written on the business
registration certificate
4 Making detailed declaration based on
the existing persons
...
...
...
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Name of
importing organization or individual
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………….
……1………, …...[date]....,
20……
Written
request for issuance of medical device import licence
To: Infrastructure
and Medical Device Administration (IMDA)
Name of importing organization or individual:
.............................................................
TIN or ID card number/Passport number:
..................................................
...
...
...
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Phone number:
...................................................................................
We hereby apply for the license to import the
following medical devices:
No.
Name of medical
device
Model/ code of
product
Manufacturer,
country of manufacture
Owner, country
of ownership
Distributor,
country of distribution
(if any)
Quantity
...
...
...
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...
...
...
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1. Purpose of import:
...........................................................................
2. User:
...................................................................................
3. We hereby declare:
...
...
...
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- The use of imported medical devices for their
intended purposes will be ensured.
We will be responsible before law for breach of the
above-mentioned commitments.
Importing
organization or individual
Signature (full name, title) with confirmation by seal or digital
signature
__________________________
1 Geographic name
Template
No. 11
...
...
...
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……1………(date)
..................., 20...
WRITTEN REQUEST
for issuance of certificate of free sale of
class C and class D medical devices
To: Infrastructure
and Medical Device Administration (IMDA)
1. The facility applying for a CFS:
1.1. Name of the facility:
………………………………………………………………..
1.2. The headquarter address: ………………… 2……………………………………….
1.3. Phone number: ......................... Fax:
…………………………………………
2. The medical device owner:
...
...
...
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2.2. Address: …………………………………………………………………..
3. Manufacturing facility:
3.1. Manufacturing facility 1:
- Name: ………………………………………………………
- Address: .............. ………………………………………………
3.2. Manufacturing facility 2:
- Name: ……………………………………………………….
- Address: .............. ………………………………………………
To meet the requirements of the importing country,
our company requests the IMDA of the Ministry to Health to issue a CFS for the
following medical devices:
...
...
...
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Name of medical
device
Model
Product code (if any)
Number of
marketing authorization
Manufacturing
facility3
1
...
...
...
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2
3
...
...
...
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Number of printed copies of the CFS requested for
issuance:
We hereby declare:
1. We included adequate documents in the application
and ensure their accuracy, legitimacy and conformity with regulations. We will
wholly be responsible for any falsification and will face penalties according
to regulations of law.
2. The fulfillment and maintenance of requirements
declared during the process of manufacture will be ensured.
...
...
...
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__________________________
1 Geographic name
2 The address written on the business registration
certificate
3 Numbering manufacturing facility
according to section 3
Template
No. 12
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
…… 1………(date)
..................., 20...
NOTIFICATION
...
...
...
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Last updated on:
………….
To: Department of
Health .....
1. Number of declaration: ……………………. Date:
….………………………
2. Updated information:
No
Out-of-date
information
Up-to-date information
...
...
...
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3. Related documents: ……………...
We hereby declare:
We will strictly comply with regulations of
Vietnamese law;
We will be responsible before the law for the
accuracy of the updates.
...
...
...
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__________________________
1 Geographic name.
Template
No. 13
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
…… 1………(date)
..................., 20...
NOTIFICATION
OF UPDATED INFORMATION IN APPLICATION FOR
DECLARATION OF APPLIED STANDARDS OF CLASS A AND CLASS B MEDICAL DEVICES
Last updated on:
………….
...
...
...
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1. Number of the applied standard declaration:
................... issued on: ………
2. Updated information:
No
Out-of-date
information
Up-to-date
information
...
...
...
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3. Related documents: ……………...
We hereby declare:
We will strictly comply with regulations of
Vietnamese law;
We will be responsible before the law for the
accuracy of the updates.
Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or signature
__________________________
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
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Template
No. 14
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
…… 1………(date)
..................., 20...
NOTIFICATION
OF UPDATED INFORMATION IN APPLICATION FOR
MARKETING AUTHORIZATION OF CLASS C AND CLASS D MEDICAL DEVICES
Last updated on:
………….
To: Infrastructure and
Medical Device Administration (IMDA)
1. Number of marketing authorization: ………. ….Date
of issue: ………….……
...
...
...
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No
Out-of date
information
Up-to-date
information
...
...
...
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We hereby declare:
We will strictly comply with regulations of
Vietnamese law;
We will be responsible before the law for the
accuracy of the updates.
Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
__________________________
1 Geographic name.
...
...
...
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
…… 1………(date)
..................., 20...
NOTIFICATION
of
updated information in application for declaration of eligibility for trading
of class B, class C and class D medical devices
Last updated on:
………….
To: Department of
Health .....
1. Number of declaration: ………….…. Date: ………………
2. Updated information:
No
...
...
...
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Up-to-date
information
3. Related documents: ……………...
We hereby declare:
...
...
...
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We will be responsible before the law for the
accuracy of the updates.
Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or signature
__________________________
1 Geographic name.
Template
No. 16
FACILITY’S NAME
-------
...
...
...
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No. …………
……1………(date)
..................., 20...
DECLARATION
OF PLANNED MEDICAL DEVICE ADVERTISING CONTENTS
AND FORMATS
To: Infrastructure
and Medical Device Administration (IMDA)
1. Name of the facility2:
..........................................................................
TIN: ..............................................................................................
Address:
....................................................................................................
...
...
...
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Email: .......................................
…………. Website (if any): ...........
2. Legal representative of the facility:
Full name:
................................................................................................
ID card number/Passport number: ……. Date of issue:
……… Place of issue: .........................
Landline: ....................... Mobile phone:
...........................
3. Information on the medical device planned for
advertisement:
- Name of the medical device:
......................................................................
- Model:
.......................................................................................
- Product code (if any):
.....................................................................
...
...
...
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- Country of manufacture:
.................................................................................
- Number of marketing authorization:
.....................................................................................
- Features and functions:
.......................................................................
- Name and address of holder of marketing authorization
number: ...........
- Health warnings for users, storage conditions (if
any):
........................................................................................................................
We hereby disclose the planned medical device advertising
contents and formats as follows:
Planned advertising contents:
……………………………………………………………………………….
...
...
...
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Planned advertising formats:
……………………………………………………………………………….
……………………………………………………………………………….
We hereby declare:
1. The disclosed information is accurate and legal
according to the regulations. We will wholly be responsible for any
falsification and will face penalties according to regulations of law.
2. The advertising content complies with the
planned advertising content that has been publicly disclosed and the
application for disclosure of applied standards for class A or class B medical
devices or the application for marketing authorization of class C or class D
medical devices.
Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
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1 Geographic name
2 The holder of marketing authorization
number or the organization authorized in writing by the holder of marketing
authorization number
APPENDIX II
PERSONNEL LIST TEMPLATE
(Enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the
Minister of Health of Vietnam)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
…....1.....,
......[date]....., 20...
Personnel list
Name of the facility:
...........................................................................................................................
...
...
...
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No.
Full name
Position
Professional qualification
Process of working in the medical device-related
field
Training process
Work unit
Work period
Designated position
...
...
...
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Name of training institution
Training major
Qualifications
Training type
Training duration
1
...
...
...
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2
...
...
...
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...
...
...
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3
...
...
...
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Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or digital signature
__________________________
1 Geographic name.
...
...
...
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APPENDIX III
TEMPLATE OF INFORMATION ABOUT APPLICATION FOR
DECLARATION, CERTIFICATE, IMPORT LICENSE
(enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the
Minister of Health)
Template No. 01
Information about application for declaration of
eligibility for production of medical devices
Template No. 02
Information about application for declaration of
applied standards of class a
medical devices
Template No. 03
Information about application for declaration of
applied standards of class B medical devices
Template No. 04
...
...
...
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Template No. 05
Information about application for declaration of
eligibility for trading of class b,
class c and class d medical devices
Template No. 06
Medical device import license
Template No. 07
Certificate of free sale
Template No. 08
Information about application for declaration of
concentration and content in materials for production of medical devices and
EQA reagents that contain narcotics/precursors
...
...
...
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...1...
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
INFORMATION
about
application for declaration of eligibility for production of medical devices
Number of
declaration: …………….
Date of
declaration: ………….
1. Name of manufacturing facility: ..............................................................................
2. Address:
................................................................................................
...
...
...
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4. Document number of the
facility:…………………………………issued on: .......................... ............
5. Name of medical device declared to be
manufactured:
......................
...........................................................................................
6. Enclosures:
1.
Declaration of eligibility for production
□
2.
ISO 13485 Certificate
...
...
...
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3.
Documents regarding the system for monitoring and
managing the processes of exporting, importing, inventory and usage of raw materials
that are narcotics and precursors, as well as the processes of exporting,
importing and inventory of medical devices containing narcotics and
precursors, and the storage warehouse.
□
__________________________
1 Department of Health of the province/central-affiliated
city where the manufacturing facility is located
Template
No. 02
...1...
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
...
...
...
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INFORMATION
About
Application for declaration of applied standards of class A medical devices
Number of
declaration: …………….
Date of
declaration: ………….
1. Name of the declaring facility:
..............................................................................
2. Address: ................................................................................................
3. Document number of the
facility:…………………………………issued on:………………….. ............................
4. Class A medical device:
Name of the medical device:
......................................................................................
...
...
...
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Global Medical Device Nomenclature - GMDN code (if
any): ................
Model: ..............................................................................................
Product code (if any):
............................................................................
Specifications of packing:
.................................................................................
Uses:
...................................................................................
Name of manufacturing facility:
..................................................................................
Address of the manufacturing facility:
............................................................................
Applied standards:
................................................................................
5. For medical device that contains narcotic or
precursor (if any):
...
...
...
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CAS Registry Number (CAS RN):
..................................................................................
Concentration and content of the narcotic or precursor:
............................................
Total content of narcotics and precursors in a
smallest packing unit:
.........................................................................................................................
6. Information about the owner of the medical
device:
The owner’s name:
.......................................................................................
Address of the owner of medical device:
.................................................................................
7. Information about warranty facility (if any):
Name of the facility:
...............................................................................................
...
...
...
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Landline: ....................... Mobile phone:
..........................
8. Number of declaration of eligibility for
domestic production of medical device:
..
........................................................…………………………………………..
9. Enclosures:
1.
Written request for declaration of applied
standards of class A medical devices
□
2.
ISO 13485 Certificate
...
...
...
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3.
Letter of authorization of the medical device
owner.
□
4.
Confirmation of eligibility for warranty
□
5.
Standard version declared to be applied by the
medical device owner
□
...
...
...
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Certificate of conformity with standards
□
7.
For a medical device manufactured in Vietnam:
adding result of evaluating chemical, physical and microbiological parameters
and other parameters granted by a qualified facility according to the
provisions of law on conformity assessment, or Certificate of quality
assessment issued by a competent authority of Vietnam for in vitro diagnostic
medical devices
□
8.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
□
9.
...
...
...
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□
10.
Certificate of free sale for the imported medical
device
□
_________________________
1 Department of Health of the
province/central-affiliated city where the facility is located
Template
No. 03
...1...
-------
...
...
...
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INFORMATION
ABOUT APPLICATION FOR DECLARATION OF APPLIED
STANDARDS OF CLASS B MEDICAL DEVICES
Number of
declaration: …………….
Date of
declaration: ………….
1. Name of the declaring facility: ..............................................................................
2. Address:
................................................................................................
3. Document number of the
facility:…………………………………issued on:………………….. ............................
4. Class B medical device:
...
...
...
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Trade name (if any):
.........................................................................
Global Medical Device Nomenclature - GMDN code (if
any): ................
Model:
..............................................................................................
Product code (if any):
............................................................................
Specifications of packing:
.................................................................................
Uses:
...................................................................................
Name of manufacturing facility:
..................................................................................
Address of the manufacturing facility:
............................................................................
Applied standards: ................................................................................
...
...
...
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Name of narcotic/ precursor: …………………. Scientific
name: ……………
CAS Registry Number (CAS RN):
..................................................................................
Concentration and content:
...............................................................................
Total content of narcotics and precursors in a
smallest packing unit: .............................
6. Information about the owner of the medical
device:
The owner’s name:
.......................................................................................
Address of the owner of medical device:
.................................................................................
7. Information about warranty facility (if any):
Name of the facility:
...............................................................................................
...
...
...
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Landline: ....................... Mobile phone:
..........................
8. Number of declaration of eligibility for
domestic production of medical device:
..
.................................................
9. Enclosures:
1.
Written request for declaration of applied
standards of class B medical devices
□
2.
ISO 13485 Certificate
...
...
...
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3.
Letter of authorization of the medical device
owner.
□
4.
Confirmation of eligibility for warranty
□
5.
Standard version declared to be applied by the
medical device owner
□
...
...
...
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Certificate of conformity with standards
□
7.
For a medical device manufactured in Vietnam:
adding result of evaluating chemical, physical and microbiological parameters
and other parameters granted by a qualified facility according to the
provisions of law on conformity assessment, or Certificate of quality
assessment issued by a competent authority of Vietnam for in vitro diagnostic
medical devices
□
8.
User manual of the medical device in Vietnamese;
for an imported medical device, an original in English, issued by the owner
of the medical device, will be enclosed with the user manual in Vietnamese
□
9.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
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□
10.
Certificate of free sale for the imported medical
device
□
__________________________
1 Department of Health of the
province/central-affiliated city where the facility is located
Template
No. 04
Ministry of Health
Infrastructure and Medical Device Administration
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No. ………………..
Hanoi,….[date]..….,
20…
Marketing
authorization of class C and class D medical devices
Pursuant to Decree No. 98/2021/ND-CP dated November
08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 07/2023/ND-CP dated March
03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 96/2023/ND-CP dated December
30, 2023 of the Government elaborating on certain Articles of the Law on
Medical Examination and Treatment;
Pursuant to Circular No. /2025/TT-BYT dated ………..,
2025 of the Minister of Health promulgating a Circular providing regulations on
the delegation of implementation of some tasks and handling of some medical
device-related administrative procedures under the jurisdiction of the Ministry
of Health and regulations on templates of documents and reports on the
management of medical devices.
The Infrastructure and Medical Device
Administration of the Ministry of Health hereby grants a marketing
authorization to the following brand-new medical device:
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2. Trade name (if any):
3. Global Medical Device Nomenclature - GMDN code
(if any):
4. Type of medical device:
5. Name and address of owner of medical device:
6. Name and address of holder of marketing
authorization number:
7. Uses; name and address of warranty facility: See
the attached appendix.
8. Detail on medical device (model; product code;
packing specification; name of manufacturing facility; address of manufacturing
facility and country of manufacture): See attached appendix.
This Certificate is granted in accordance with
Decision No………
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AUTHORITY AND
POSITION OF SIGNER
(signature of competent person, seal of issuer)
Full name
ENCLOSED APPENDIX
1. Uses:
2. Name, address of warranty facility:
3. Details on medical device:
No
Name of medical
device
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Product code
(if any)
Packing specification
(if any)
Name of
manufacturing facility
Address of
manufacturing facility
Country of
manufacture
...
...
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...
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Template
No. 05
...1...
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
INFORMATION
about
application for declaration of eligibility for trading of class B, class C and
class D medical devices
Number of
declaration: …………….
Date of
declaration: ………….
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.........................................................................................................................
2. Address: .......................................................................................................
3. Document number of the
facility:…………………………………issued on:………………….. ..................................
4. Enclosures:
1.
Declaration of eligibility for trading
□
2.
Personnel list
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3.
Records of storage warehouse of medical devices
□
4.
Records of means of transport of medical devices
□
5.
Documentary evidence of the storage warehouse and
system for monitoring and managing the exporting, importing and inventory
process of medical devices containing narcotics and precursors
□
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1 Department of Health of the
province/central-affiliated city where the applicant is located
Template
No. 06
Medical device import license
MINISTRY OF HEALTH
INFRASTRUCTURE AND MEDICAL DEVICE ADMINISTRATION
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ………………..
Hanoi,….[date]..….,
20…
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Pursuant to Decree No. 98/2021/ND-CP dated November
08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 07/2023/ND-CP dated March 03,
2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated November
08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 96/2023/ND-CP dated December
30, 2023 of the Government elaborating on certain Articles of the Law on
Medical Examination and Treatment;
Pursuant to Circular No. /2025/TT-BYT dated ………..,
2025 of the Minister of Health promulgating a Circular providing regulations on
the delegation of implementation of some tasks and handling of some medical device-related
administrative procedures under the jurisdiction of the Ministry of Health and
regulations on templates of documents and reports on the management of medical
devices.
Considering the request in Official Dispatch No.
…………. dated…………… on ………….. The Infrastructure and Medical Device Administration
of the Ministry of Health hereby comes to an agreement with the request of (the
applicant) on import of consignment of brand-new medical devices. To be
specific:
No.
Name of medical
device
Model/ code of
product
Manufacturer,
country of manufacture
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Distributor,
country of distribution
(if any)
Quantity
Unit
...
...
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AUTHORITY AND
POSITION OF SIGNER
(Signature of competent person, seal of issuer)
Full name
__________________________
1 Name of importing organization or
individual.
Template
No. 07
VIET NAM
INFRASTRUCTURE AND MEDICAL DEVICE ADMINISTRATION
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Hanoi, date ...
month ... year …
CERTIFICATE OF FREE SALE
1. Certificate No: .............. /CFS/HTTB
2. Product Owner:
Address:
3. Information of medical devices: (Product name;
Model; Product code; Market Authorization number in Vietnam and Manufacturing
site): See attached annex.
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This certificate is issued according to Decision
No: .......
Authority and position of the signer
(signature of the competent person, seal of the issuer (organization or
agency))
Full name
Page …/….
Attached Annex
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I. Manufacturing site(s):
1. Name of Manufacturer:
Address:
2. Name of Manufacturer:
Address:
II. Name of Product(s):
1. Product name:
Model:
Product code:
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Name of Manufacturer
2.
Product name:
Model:
Product code:
Market Authorization number in Vietnam:
Name of Manufacturer:
Page …/….
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Template
No. 08
...1...
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
INFORMATION
about
application for declaration of concentration and content in materials for
production of medical devices and EQA reagents that contain
narcotics/precursors
Number of
declaration: …………….
Date of
declaration: ………….
1. Name of the declaring facility: .........................................................................................
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Address:
…………………………………………………………….....................
Transaction office (if any):
...........................................................................
2. Legal representative of the facility:
Full name: ………………………………………………………………………..
ID card number/Passport number: ……. Date of issue:
……… Place of issue: …………….
Landline: ............................... Mobile
phone: ……………………
3. Information on materials used for production of
medical devices and eqa reagents
that contain narcotics/precursors:
Product name: ..............................................................................................
Model:
......................................................................................................
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Packing specification (if any):
...........................................................................
Uses:
...........................................................................................
Applied standards:
........................................................................................
Name of manufacturing facility:
..........................................................................................
Address of the manufacturing facility:
....................................................................................
The owner’s name:
...............................................................................................
Address of the owner of medical device:
.........................................................................................
4. Information on narcotics/precursors contained in
materials used for production of medical devices and EQA reagents:
Name of narcotic/ precursor: .............................................................................
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CAS code
.........................................................................................................
Concentration and content:
.......................................................................................
Total content of narcotics and precursors in a
smallest packing unit: .....................................
5. Enclosures:
1.
Declaration of materials used for production of
medical devices and EQA reagents that contain narcotics/precursors
□
2.
Certificate of quality (CQ)
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3.
Technical document
□
__________________________
1 Department of Health of the province/central-affiliated
city where the applicant is located
APPENDIX IV
TEMPLATE OF WRITTEN COMMITMENT AND APPLICATION FOR
CONTINUED CIRCULATION OF CLASS C AND CLASS D MEDICAL DEVICES
(enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the
Minister of Health)
Template No. 01
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Template No. 02
Written consents for continued circulation of
class C and class D medical devices
Template
No. 01
Facility’s name
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. …………….
……1… …..,……(date)……..
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To: Infrastructure
and Medical Device Administration (IMDA)
Name of the facility:
...............................................................................................
TIN:
..............................................................................................
Address:
.........................................................................................
.............
Legal representative:
........................................................................
Phone number: ....................................................................................
We are ….2…. . We are distributing the
following medical devices:
Name of the medical device:
................................................................................
Number of marketing authorization:
............................... Date of issue:
...............................................
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- We will be responsible for ensuring the quality,
model and number of medical devices granted marketing authorization number.
- The medical devices will be circulated on the
market for a maximum period of 24 months.
- We will be responsible for the warranty,
maintenance and servicing of such medical devices.
- We will provide materials and replacement
accessories during the 8-year period of use.
- We have adequate and qualified personnel in
charge of effectiveness and safety of medical devices for users and
environment, and ensure that the quality of the imported medical devices is not
affected during transport and in our facilities. The medical device labels meet
requirements.
- Medical devices are used for their intended
purposes. We will facilitate inspections by competent authorities.
We will be responsible before law for breach of the
above-mentioned commitments.
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__________________________
1 Geographic name.
2 Name of distributing facility.
3 Name of the medical device owner
or name of the holder of the marketing authorization number.
Template
No. 02
Written consents for continued circulation of class
C and class D medical devices
MINISTRY OF HEALTH
INFRASTRUCTURE AND MEDICAL DEVICE ADMINISTRATION
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
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Hanoi,….[date]..….,
20…
To:
..............................................
Pursuant to Decree No. 98/2021/ND-CP dated November
08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 07/2023/ND-CP dated March
03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices;
Pursuant to Circular No. /2025/TT-BYT dated ………..,
2025 of the Minister of Health promulgating a Circular providing regulations on
the delegation of implementation of some tasks and handling of some medical
device-related administrative procedures under the jurisdiction of the Ministry
of Health and regulations on templates of documents and reports on the
management of medical devices.
Considering the content of the proposal in Official
Dispatch No. ........ dated ....... from ................ on the request to
continue the circulation of medical devices and the commitment to assume
responsibility for warranty, maintenance and supply of materials for the use of
medical devices, the IMDA of the Ministry of Health agrees with the proposal of
the organization or individual regarding the circulation of medical devices. To
be specific:
Name of the medical device: ………………………………………………………..
Number of marketing authorization: ……………………. Date
of issue: …………………………….
...
...
...
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The company………. assumes responsibility for:
- ensuring the quality, model and quantity of
medical devices granted marketing authorization number.
- providing warranty, maintenance and servicing of
such medical devices.
- Providing materials and replacement accessories
during the 8-year period of use.
- Ensuring that we have qualified personnel in
charge of effectiveness and safety of medical devices for users and environment
and the quality of the imported medical devices is not affected during
transport and in our facilities. Meeting requirements for medical device
labels.
- Ensuring that medical devices are used for their
intended purposes. We will facilitate inspections by competent authorities.
POSITION OF
SIGNER
Signature (full name, title)
Confirmed by seal or signature
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APPENDIX V
LETTER OF AUTHORIZATION TEMPLATE
(Enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the
Minister of Health of Vietnam)
Headline (name and address) of the medical device
owner
…[date]……, 20 ....................
LETTER OF
AUTHORIZATION
To:
..........................................................
We, (name and address of the Product Owner), as the
owner of the medical devices listed hereunder, hereby authorize (name and
address of the organization authorized to announce applicable standards in its
name or register for circulation) to place/ register the following medical
devices to the market of Vietnam:
"..........(List
of the medical device)........."
We hereby commit to provide and support any inquiry
related to the information and quality of the medical devices, guarantee all
warranty, maintenance and service conditions and supply replacement materials
and accessories for the medical devices.
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Legal
representative of the owner
Signature (full name, title)
Confirmed by seal or signature
APPENDIX VI
CONFIRMATION OF ELIGIBILITY FOR WARRANTY TEMPLATE
(Enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the
Minister of Health of Vietnam)
Headline (name and address) of the medical device
owner: ……….
…[date]……, 20 ....................
Confirmation of eligibility for warranty
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Address:…………………………………………………………………………..
As the owner of the medical device, we confirm that
the below-named facilities are eligible for warranty on the medical device of
…..1……………:
Name of medical
device
Name of
warranty facility
TIN
Address
Landline
Mobile phone
......
...
...
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Facility 2
...
...
...
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Facility 1
Facility 2
...
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Facility 3
......
......
...
...
...
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Legal
representative of the owner
Signature (full name, title)
Confirmed by seal or signature
__________________________
1 Full name of the owner of the medical
device
APPENDIX VII
TEMPLATES OF TECHNICAL DOCUMENTS FOR MEDICAL DEVICES
(enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the
Minister of Health)
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Technical documents for medical devices that are
IVD reagents, calibrators, controls
Template No. 02
Brief technical description of chemicals
and preparations serving solely the purpose of disinfecting medical devices
Template No. 03
Brief technical description of domestically manufactured
medical devices which are neither IVD reagents, calibrators, controls nor
chemicals and preparations serving solely the purpose of disinfecting medical
devices
Template No. 04
Brief technical description of imported medical
devices which are neither IVD reagents, calibrators, controls nor chemicals
and preparations serving solely the purpose of disinfecting medical devices
Template No. 05
Common Submission Dossier Template (CSDT)
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Brief technical description of medical devices
serving the issuance of import licenses
Template
No. 01
Technical
documents for medical devices that are IVD reagents, calibrators, controls
Name and address of facility registering for
circulation of medical device
………(date) ...................., 20….
No
Heading
Description
...
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General description of medical device
1.1
Overview description
Description and introduction of the medical
device, its purposes and any complementary products (if applicable).
1.2
The history of product launches
State the name of the first country to be granted
a license and the year of issuance.
1.3
Uses
...
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1.4
List of countries in which licenses have been
granted
List the countries in which licenses have been
granted and the year of issuance.
1.5
The status of submitted licensing applications
pending approval in various countries
List the countries in which applications have been
submitted but have not yet been granted approval.
1.6
Important information regarding the safety and
effectiveness of product
Provide reports on adverse reactions that have
occurred and the corrective actions that have been taken since the product was
placed on the market (within the past five years).
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Description of the medical device
2.1
Description of the medical device
Describe the operating principle, features, and
technical specifications of the medical device.
2.2
User manual
Brief instructions for use of the medical device
as prescribed in the Instruction sheet or Information sheet of the medical
device
2.3
Contraindications
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2.4
Warnings and precautions
Provide warnings and precautions when using the medical
device, including preventive measures to protect patients from risks caused
by the use of the medical device. They can be warnings about adverse effects
or misuse and precautions
2.5
Adverse effects
Provide adverse effects related to the use of the
medical device that is recorded through clinical trials and after-sales
service which have been previously performed for the medical device
2.6
Alternative method (if any)
Present alternative methods to achieve the
intended purpose.
...
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Technical specifications
The performance features and technical
specifications include: detection limits, accuracy, sensitivity, specificity,
reliability and other factors; additional specifications encompassing
chemical, physical and biological properties, sterility, stability (shelf
life), storage, transportation and packaging.
III
Manufacture/production of medical device
3.1
Manufacturer
Identify the manufacturers involved in the
production process and the quality management system applied
3.2
Assessment standards and methods for class C and
D IVD medical devices
...
...
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3.3
Stability
Summarize the investigation results and
conclusions regarding the stability of the product under storage conditions
over real-time periods and accelerated aging investigations/studies (if any),
during transportation and during use after opening (if any).
IV
Investigation report
4.1
Preclinical and clinical investigation
Summarize preclinical and clinical investigation
results of the product
4.2
...
...
...
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List references (if any)
V
Assessment of medical device quality in
Vietnam
Quality assessment information provided by the
competent authorities of Vietnam
We certify that the above-mentioned information is true.
We will be responsible before law for the above-mentioned information.
Legal
representative of the facility
(Signature (full name, title))
Confirmed by seal or signature
...
...
...
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Brief
technical description of chemicals and preparations serving solely the purpose
of disinfecting
MEDICAL DEVICES
Name and address of facility registering for
circulation of medical device
………(date) ...................., 20….
No
Heading
Content
1
Description of medical device
...
...
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Description of the medical device
Required information:
a) Composition of the preparation:
- Main composition (antimicrobial substances):
Content; Manufacturer; UN No. (if any).
- Other auxiliary components of the preparation
along with their content.
b) Physicochemical properties of the preparation:
Specific gravity (relative density) for liquids; Flammability, flash point;
Corrosiveness; Storage stability; Acidity, alkalinity or pH; Compatibility
with other preparations.
c) The biological efficacy of the preparation:
- The mechanism of action of the preparation for
sterilization/disinfection/cleaning...
- Sterilization/disinfection/cleaning
capabilities..., types of bacteria.
...
...
...
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- Method of use.
- The exposure time of the chemicals to the test
microorganisms.
- The interval between uses (for preparations
with residual effects)
- Diluent environment, if any (water, oil, etc.)
d) Form of preparation.
e) Preservation conditions.
f) Expiry date.
1.2
Purposes/Indications
...
...
...
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1.3
User manual
Summarize instructions on how to use, store and
observe safety precautions when using the preparation… according to the
Instruction sheet or the Information sheet of the medical device.
1.4
Contraindications
Information regarding cases where the use of
medical devices is not recommended for safety reasons for users or the
environment, etc.; in accordance with the instructions on the product label and
as approved in the country of manufacture (if applicable).
1.5
Warnings and precautions
Warnings and precautionary statements to be
considered when using:
...
...
...
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- Assessments of the toxicity of the product such
as: acute oral toxicity (LD50); acute dermal toxicity (LD50);
acute inhalation toxicity (LC50); eye irritation potential; skin
irritation potential; allergenic potential.
- Information on ecological toxicity,
degradability, and persistence.
b) Information related to acute toxicity;
semichronic toxicity; chronic toxicity; genotoxicity, carcinogenicity;
reproductive and developmental toxicity; environmental metabolism potential;
and ecological toxicity of antimicrobial substances (not required for
chemicals or preparations whose sole purpose is the disinfection of medical
devices categorized as class B).
c) Medical information, poisoning symptoms,
antidotes (if available).
d) Other information such as the methods for
disposing of expired or unused preparations; methods for disposing of
preparation packaging.
1.6
Adverse effects
Information regarding adverse effects related to
the use of the product, such as potential negative impacts that may occur in
individuals when using the product…
2
...
...
...
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Information on the countries granting product
marketing authorization, the date of issue; and the approved indications of
the product in each country.
3
Information related to adverse reactions,
corrective actions (if any)
a) Provide information on the number of reports
on adverse reactions related to the use of medical devices.
b) Corrective actions for ensuring the safety in
the market.
4
Information on product recalls (if any)
Information regarding product recalls since the
products were released to the market.
The recall/after-sales adjustment measures that
have been implemented in accordance with the requirements of the regulatory
authorities of the respective countries.
...
...
...
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Manufacturer
Identify the manufacturers involved in the
production process and the quality management system applied
6
Medical device quality assessments
Results of the testing of composition and content
of antimicrobial active substances; trial of bio-efficacy of products
We certify that the above-mentioned information is
true. We will be responsible before law for the above-mentioned information.
Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or signature
...
...
...
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Template
No. 03
Brief
technical description of domestically manufactured medical devices which are
neither IVD reagents, calibrators, controls nor chemicals and preparations
serving solely the purpose of disinfecting medical devices
Name and address of facility registering for
circulation of medical device
....[date]...., 20…
No
Heading
Content
I
General description of medical device
...
...
...
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Overview description
Overview description of medical device, including:
Introduction of the medical device, its purposes and indications for use, and
any new features if available (for example: use of nanotechnology, artificial
intelligence, etc.).
1.2
The history of product launches
List of countries in which the product was sold
on the market, attached to the first year (if any) in which the product was
sold on the market.
1.3
Uses
Purposes, indications for use of the medical
device as stated on the label or in the device's instruction manual.
1.4
...
...
...
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Information about marketing authorization of the
products in EU countries, Japan, Canada, Australia (TGA), USA (FDA), UK,
Switzerland, including the licensing status (approved, pending approval,
rejected, unregistered/non-registration, etc.), purposes, indications,
initial authorization date.
1.5
Important information regarding the safety and
effectiveness of product
Brief information on adverse events that have
been occurred, corrective actions for ensuring the safety in the market that
have been taken since the products were introduced to the market or over the
latest 5 years.
If a medical device contains any of the following
composition, that composition must be clearly specified:
- Human or animal cells or tissues or their
derivatives intended for use in a non-viable form, e.g. artificial heart
valves from pig or cat intestines, etc.;
- Cells, tissues or derivatives of microbial or
recombinant origin, e.g. hyaluronic acid-based dermal fillers obtained by
bacterial fermentation, etc.
- Containing radioactive or ionizing ingredients
(e.g. X-ray); or non-ionizing (E.g. laser, ultrasound, etc.).
II
...
...
...
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2.1
Description of the medical device
Detailed description of characteristics of the
medical device for explaining principles of action of the medical device,
explaining basic science concepts that make up the fundamentals of the
medical device. Description of components and accessories used to help the
device operate as well as package. Full description of each functional
component, material or raw material of the medical device, accompanied by a
visual of the medical device in the form of a diagram, photograph or drawing,
as appropriate.
2.2
User manual
All necessary information provided from the
product owner including procedures, methods, frequency, timing, quantities
and preparations that must be followed for the safe use of the medical
device.
2.3
Contraindications
Information on cases for which the medical device
must not be used for reasons of patient safety, for example, due to the
patient's medical history, physiological characteristics, etc., in accordance
with the contents stated on the label of the medical device or user manual of
the medical device.
...
...
...
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2.4
Warnings and precautions
Warnings about specific dangers that users need
to know before using medical devices.
Warnings issued to users to take necessary
precautions for the safe and effective use of the medical device.
Including actions to be taken to avoid effects to
the patient/user, which may not be life-threatening or cause serious injury,
but of which the user should be aware. Precautions may also warn users
about the adverse effects when using or incorrectly using the medical
devices, which can be avoided if the precautions are taken.
2.5
Potential adverse effects
These are unwanted and serious consequences
(death, injury, or serious adverse events) that may occur to the
patient/user, or side effects from the use of the medical device under normal
conditions.
2.6
...
...
...
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Description of alternative procedures or actions
for diagnosing, treating or mitigating the disease or condition for which the
medical device is intended.
2.7
Information about materials
- A list of materials of the medical device that
come into direct contact with the body (E.g. Mucous membrane) and indirect
contact with the body (e.g. circulation of extracellular fluid (ECF)), and
their chemical, biological and physical characteristics shall be provided.
- Regarding medical devices that emit ionizing
radiation, information about sources of radiation (e.g. radioactive isotopes)
and materials used to protect users and patients from unexpected radiation
must be provided.
- In cases where there are special requirements
regarding the safety of a material such as impurities, level of residue and
exposure to plasticizers such as Bis (2-ethylhexyl ethylhexyl) phthalate
(DEHP), a certificate of conformity to relevant standards, a certificate of
analysis, or a safety assessment report of such material must be added
Depending on risks incurred when exposing to these materials, additional
measures may be required, such as notifying users of the presence of these
materials by labeling the on the product.
2.8
Other relevant specifications
Characteristics of the functions and technical
specifications regarding the operation of medical devices include: accuracy,
sensitivity, specificity of medical measuring and diagnostic devices,
reliability and other factors (if relevant); and other specifications
including chemistry, physics, electricity, mechanics, biology, software,
sterility, stability, storage, transportation and packaging.
...
...
...
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Synopsis of design verification and validation
This section must summarize or refer to or
include design verification data and design validation data, appropriate to
the complexity and risk classification of the medical device.
Documents include:
● Certificates or declarations of conformity to
the recognized standards applied by the product owner; and/or
● Summaries or test reports and evaluations based
on other standards, methods and trials of the manufacturer, or other means to
demonstrate compliance with the product standards.
IV
Clinical evidence
...
...
...
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A clinical evaluation report includes purposes
and context of the clinical evaluation, input clinical data, data appraisal
and analysis, conclusions about safety and effectiveness of the medical
device.
The clinical evaluation report should contain
sufficient information as a standalone document for a regulatory authority to
review. The clinical evaluation report should provide an overview of:
- Technology used by such medical device,
indications for use, statements about the safety and clinical effectiveness
of that medical device, if any.
- Nature and scope of the clinical data to be
evaluated.
- Clinical data and recognized standards proving
the safety and effectiveness of the medical device.
V
Manufacture information
5.1
Manufacturer
...
...
...
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5.2
Manufacturing process
It is required to include information serving the
general perception of the manufacturing process. No proprietary details are
required. This information can be presented in the form of a manufacturing
flow diagram that briefly describes the process of manufacture, in-process
quality control, assembly, quality control and packaging of the final
product.
If multiple manufacturers are involved in the
manufacturing process to complete a product, it is necessary to clearly state
which activities each manufacturer is involved in.
We certify that the above-mentioned information is
true. We will be responsible before law for the above-mentioned information.
Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or signature
...
...
...
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Brief
technical description of imported medical devices which are neither IVD
reagents, calibrators, controls nor chemicals and preparations serving solely
the purpose of disinfecting medical devices
Name and address of facility registering for
circulation of medical device
………(date) ...................., 20….
No
Heading
Brief
description
1
Description of medical device
1.1
...
...
...
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Provide brief prescription of operating
principles and features and technical parameters of the medical device;
specify that if the device uses new technologies, a description of such new
technologies (e.g. nanotechnology) should be provided.
1.2
Catalog of parts and accessories
Make a list of parts and accessories of the
medical device
1.3
Purposes/Indications
Specify purposes/indications of the medical
device
1.4
User manual
...
...
...
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1.5
Contraindications
Provide information on the contraindication –
means cases in which the medical device must not be used for reasons of
patient safety, for example due to the patient's medical history,
physiological characteristics, etc.; that is in accordance with the approved
content in the country in which marketing authorization is granted and is
stated on the label of the medical device
1.6
Warnings and precautions
Provide warnings and precautions when using the medical
device, including preventive measures to protect patients from risks caused
by the use of the medical device. They can be warnings about adverse effects
or misuse and precautions
1.7
Adverse effects
Provide adverse effects related to the use of the
medical device that are recorded through clinical trials and after-sales
service which have been previously performed for the medical device
...
...
...
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Provide information on the product that has been
circulated in countries (if any)
Provide information on the countries in which the
certificate of marketing authorization of the product is granted, or the
first country in which the certificate of marketing authorization of the
medical device is granted
3
Provide indications that have been registered in
other countries (if any)
Make a list of countries in which marketing
authorization attached with the indications approved in these countries are
granted; dates of issue of the marketing authorization
4
Notable information about the safety/operation of
the medical device:
- Provide information on the number of reports on
adverse effects related to the use of the medical device; measures for
recall/adjustment of after-sales services implemented at the request of
regulatory authorities of some countries;
- Provide the following information if the
medical device contains such components:
...
...
...
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● Cells, tissues and/or derivatives of microbial
or recombinant origin – e.g. skin plumping products based on hyaluronic acid
obtained by bacterial fermentation, etc.; Contain irritating, ionizing
ingredients – e.g. X-ray; or non-ionizing - E.g. laser, ultrasound, etc.
5
Reports on clinical assessment of class C and
D medical devices which are not in vitro diagnostic medical devices
5.1
Clinical assessment
Reports on clinical assessment of the owners of
the medical devices in Vietnamese or English
5.2
References of the clinical assessment
List of references (if any)
...
...
...
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Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or signature
Template
No. 05
Common
Submission Dossier Template (CSDT)
Name and address of facility registering for
circulation of medical device
We certify that the below-mentioned information is
true. We will be responsible before law for the below-mentioned information.
1. General description of medical device
...
...
...
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Overview description of medical device, including: Introduction
of the medical device, its purposes and indications for use and any new
features if available (for example: use of nanotechnology, artificial
intelligence, etc.).
1.2. Sales history of product on the market
Provide a list of countries in which the product
was sold on the market, attached to the first year (if any) in which the
product was sold on the market.
1.3. Purposes, indications for use
Specify purposes, indications for use of the
medical device as stated on the label or in the device's instruction manual.
1.4. Information of the grant of marketing
authorization in countries
Provide information about the status of marketing
authorization of the product in EU countries, Japan, Canada, Australia (TGA),
USA (FDA), UK, Switzerland, including the licensing status (approved, pending
approval, rejected, unregistered/non-registration, etc.), purposes,
indications, initial authorization date1.
This information may be presented in tabular form
as follows:
No
...
...
...
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Purposes/Indications
Marketing
authorization status
Date of issue
1
2
...
...
...
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3
Provide copies or links to online documents on the
grant of marketing authorization in the above-mentioned countries (if any).
...
...
...
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Provide brief information on adverse events that
have been occurred, corrective actions for ensuring the safety in the market
that have been taken since the products were introduced to the market or over
the latest 5 years.
Provide brief information on adverse events that
have been occurred, containing at least a description of the adverse events,
number of adverse events or frequency of occurrence (total number of adverse
events recorded per total number of products sold). This information may be
presented in tabular form as follows:
No
Description of
adverse event
Number or
frequency of occurrence
1
2
...
...
...
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3
Provide information on corrective actions for ensuring
the safety in the market, containing at least date of occurrence, brief
description of the event, and name of the country or territory that took
corrective action. This information may be presented in tabular form as
follows:
No
Date
Brief description
of the event
Name of the
country or territory
...
...
...
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2
3
...
...
...
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Provide a written confirmation from the products’
owner if there have been no adverse events, no corrective action since selling
products or over the latest 5 years.
Indicate whether the medical device contains one of
the following ingredients:
- Human or animal cells or tissues or their
derivatives intended for use in a non-viable form – e.g. artificial heart
valves from pig or cat intestines, etc.;
- Cells, tissues or derivatives of microbial or
recombinant origin – e.g. hyaluronic acid-based dermal fillers obtained by
bacterial fermentation, etc.
- Radioactive or ionizing ingredients (e.g. X-ray);
or non-ionizing (E.g. laser, ultrasound, etc.).
2. Essential principles checklist (available
in Vietnamese or English)
Provide a checklist of essential principles
regarding the safety and effectiveness of medical devices issued by the medical
device owner as prescribed in the Appendix enclosed to prove the product is
suitable to the related essential principles.
If the medical device has been granted a marketing
authorization in EU countries, an essential principles checklist may be made
and submitted in accordance with EU regulations.
...
...
...
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3.1 Description and presentation of
characteristics of the medical device
Provide a detailed description of characteristics
of the medical device for explaining its operating principles, clarifying basic
scientific concepts that make up the fundamentals of the medical device.
Provide a description of components and accessories used to enable the
operation and packaging of the device. Provide a full description of each
functional component, material or raw material of the medical device,
accompanied by a visual of the medical device in the form of a diagram,
photograph or drawing, as appropriate.
3.2 Uses
State the intended use of the medical device
matching the data provided by the product owner in the user manual as well as the
operational capabilities of the medical device.
3.3 Indications
Provide a general description of the pathology or
condition that the medical device diagnoses, treats, prevents or mitigates,
including a description of the target patient group for which the medical
device is designed to be used.
3.4 User manual
All necessary information provided from the product
owner including procedures, methods, frequency, timing, quantities and
preparations that must be followed for the safe use of the medical device.
3.5 Contraindications
...
...
...
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Provide a description of diseases or cases and
patient groups for which medical devices are not to be used for the purpose of
diagnosis, treatment or alleviation of disease. Contraindications are cases in
which the use of medical devices is not permitted because the risks clearly
outweigh the potential benefits.
3.6 Warning
Provide warnings about specific dangers that users
need to know before using medical devices.
3.7 Precautions
Warn users to take necessary precautions for the
safe and effective use of medical devices. This may include actions that need
to be taken to avoid effects to the patients/users; such effects may not pose a
life-threatening risk or cause serious injury but the users should be aware of
them. Precautions may also warn users about the adverse effects when using or
incorrectly using the medical devices, which can be avoided if the precautions
are taken.
3.8 Potential adverse effects
These are unwanted and serious consequences (death,
injury, or serious adverse events) that may occur to the patient/user, or side
effects from the use of the medical device under normal conditions.
3.9 Alternative therapy
Describe alternative procedures or actions for
diagnosing, treating or alleviating the disease or condition for which the
medical device is intended.
...
...
...
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Describe materials of the medical device and its
characteristics for proving the conformity with relevant essential principles.
Regarding a non-IVD medical device:
A list of materials of the medical device that come
into direct contact with the body (E.g. Mucous membrane) and indirect contact
with the body (e.g. circulation of extracellular fluid (ECF)), and their
chemical, biological and physical characteristics shall be provided.
Regarding medical devices that emit ionizing
radiation, information about sources of radiation (e.g. radioactive isotopes)
and materials used to protect users and patients from unexpected radiation must
be provided.
In cases where there are special requirements
regarding the safety of a material such as impurities, level of residue and
exposure to plasticizers such as Bis (2- ethylhexyl) phthalate (DEHP), a
certificate of conformity to relevant standards, a certificate of analysis, or
a safety assessment report of such material should be added. Depending on risks
incurred when exposing to these materials, additional measures may be required,
such as notifying users of the presence of these materials by labeling the on
the product.
For IVD reagents, calibrators, controls:
A list of all the materials used in the production
of the product, including name of material and its role in the finished product
shall be provided.
Information about the composition, biological
characteristics, and origins of materials involved in the testing reactions:
antigens, antibodies, enzymes, conjugates, PCR primers, probes, calibrators,
controls, etc. shall be provided.
For medical devices containing substances requiring
special control (narcotics or radiation-producing materials, either
non-ionizing or ionizing), it is required to provide adequate information about
the composition, content and role of these substances, for example,
Buprenorphine in drug testing kits, Iodine-131 in radioimmunoassay kits,
Phosphorus-32 (32P) -labeled DNA probes in Southern blot methods, etc.
...
...
...
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3.11 Other relevant specifications
Characteristics of the functions and technical specifications
regarding the operation of medical devices include: accuracy, sensitivity,
specificity of medical measuring and diagnostic devices, reliability and other
factors (if relevant); and other specifications including chemistry, physics,
electricity, mechanics, biology, software, sterility, stability, storage,
transportation and packaging for proving the conformity with relevant essential
principles.
3.12 Other information
Other important characteristics that are not
mentioned above for proving the conformity with relevant essential principles
(for example: the biocompatibility of medical devices, etc.).
Notes: in cases where the
above-mentioned information is provided in the user manual, the user manual may
be used for reference
4. Synopsis of design verification and
validation (in Vietnamese or English)
This section must summarize, refer to or include
design verification data and design validation data, appropriate to the
complexity and risk classification of the medical device.
This document includes:
Certificates or declarations of conformity to the
recognized standards applied by the product owner; and/or
...
...
...
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E.g. If the essential principles checklist mentions
that the manufacturer uses a recognized standard to demonstrate conformity with
an essential principle, a Declaration of Conformity to that standard must be
provided, or a certificate of conformity, and a summary of the trial data if
that standard does not include performance requirements.
Summaries of data or trial reports and evaluation,
depending on the complexity and classification of the risk level of medical
devices, typically include:
The list and conclusions drawn from published
reports related to the safety and efficacy of medical devices in accordance
with the essential principles;
Technical tests;
Laboratory tests;
Biocompatibility tests;
Animal experiments;
Using under simulated conditions;
Software evaluation.
...
...
...
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Detailed information on all biocompatibility tests
performed on materials used in the medical device shall be provided. All
significantly different materials must be described. Description of tests,
results and data analyses must be provided.
Physical preclinical testing data must be
fully provided, as appropriate. A report must include objectives, methods,
results and conclusions of the product’s owner for all physical investigations
of the medical device and components. Physical testing shall be performed to
forecast the adequate response of the medical device to physical pressure,
adverse conditions and effects, long-term use and all known and probable causes
of device failure.
Reports on preclinical investigations on animals
used to demonstrate possible effects of the medical device on humans shall be
provided. These investigations must be conducted in compliance with good
laboratory practice (GLP). A report must include objectives, methods, results,
analyses and conclusions of the product’s owner. Conclusions of each
investigation must address the interactions of the medical device with animal
fluids and tissues and the effectiveness of the medical device in experimental
animal model(s). Rationales (and limitations) of choosing specific animal
models should be discussed.
Evidences of electrical safety and electromagnetic
compatibility shall be provided. For example, if the owner declares that the
product meets the requirements of IEC 60601-1 and IEC 60601-1-2, a test summary
report and/or certificate of conformity must be provided to demonstrate that
the medical device meets these standards.
Regarding sterilized medical devices, sterilization
validation reports must be provided. If a sterilant is toxic or produces a
toxic residue (e.g., Ethylene Oxide), data and test methods must be provided to
demonstrate that the amount of sterilant or residue is within acceptable
limits.
Evidences of cybersecurity for network-connected,
internet-connected or wireless medical devices shall be provided. Such as:
analyses of risks and possibilities of cyber attacks, cyber security control
methods, plans, processes or mechanisms for monitoring, promptly detecting and
managing security-related threats during the life cycle of the medical device.
Declarations from the manufacturer or the owner stating that the medical
device, which is network-connected, internet-connected or wireless-connected,
ensures cyber security and safety may be provided.
4.1.1 Software verification and validation
investigations (if applicable)
The correctness of a software product is another
important characteristic of the product that cannot be fully validated in a
finished product. The product owner must provide evidence confirming the
software design and development process. This information includes results of
the verification, validation and testing of the software done internally and in
user’s environments prior to official launch, for all different hardware configurations
such as mentioned on the label or in the user manual, as well as representative
data obtained from both trial environments.
4.1.2 Medical device containing biological
materials
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4.2 Preclinical investigations for IVD reagents,
calibrators, controls
4.2.1 Analytical performance
It is required to provide investigation reports on
the analytical performance of the medical device, including: analytical
sensitivity, analytical specificity, limit of detection (LOD), limit of
quantitation (LOQ), linearity, range, accuracy, repeatability, interfering
substances, robustness, etc. Performance criteria will depend on each
medical device.
Information on samples used for evaluation
(negative controls, positive controls, baseline standards, calibrator panels,
reagents, ...).
Investigation reports should include objectives,
methods, results, and conclusions of the investigation. The results and
conclusions should clearly demonstrate that the product has the characteristics
suitable for its intended use.
4.2.2 Stability
It is required to provide stability investigation
reports, including both real-time shelf-life stability and accelerated
shelf-life stability (if applicable). In the event that real-time shelf-life
stability investigations are not conducted but only accelerated shelf-life
stability investigations are conducted, a comprehensive and reasonable
explanation is required.
In-use stability investigation reports for products
that are repeatedly used after opening shall be provided.
It is required to provide shipping stability
investigation reports, in which the products are shipped under real or
simulated conditions.
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4.3 Clinical evidence
A clinical evaluation report of the medical device
shall be provided. This evaluation may be taken in the form of a systematic
review of available references, based on clinical experience with that medical
device or similar medical device, or may be conducted through clinical
investigations. Clinical investigations are often necessary for high risk
medical devices, or medical devices where there is little or no clinical
experience.
A clinical evaluation report should include
purposes and context of the clinical evaluation, input clinical data, data
appraisal and analysis, conclusions about safety and effectiveness of the
medical device.
The clinical evaluation report should contain
sufficient information as a standalone document for a regulatory authority to
review. The clinical evaluation report should provide an overview of:
- Technology used by such medical device,
indications for use, statements about the safety and clinical effectiveness of
that medical device, if any.
- Nature and scope of the clinical data to be
evaluated.
- Clinical data and recognized standards proving
the safety and effectiveness of the medical device.
4.3.1 Data collected from available references
If the product’s owner uses existing investigations
and references to prove the safety and effectiveness of the medical device,
copies of these documents should be provided.
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4.3.2 Data collected from clinical experience
Clinical experience is clinical data obtained from
clinical use of the medical device, not from clinical investigations. Clinical
experience may be of the medical device or comparable devices.
Clinical experience may be obtained from the
following data:
Post-market surveillance reports of the product’s
owner, regulatory authorities, cohort investigations (may contain unpublished
long-term investigation data on safety and effectiveness).
Data on adverse events occurred obtained from the
product’s owner or from regulatory authorities.
Data obtained from patients using the medical
device in the pre-market aid program.
Information on clinically relevant field corrective
actions such as recalls, notifications, hazard warnings.
4.3.3 Clinical investigation data
A clinical investigation is a systematic study on
or in human subjects, undertaken to assess the safety and effectiveness of a
medical device.
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The clinical investigation must conform to the
ethical standards of the Declaration of Helsinki (DoH).
For an IVD medical device: Clinical investigations
are investigation conducted to establish or validate the clinical performance
of IVD medical devices. Manufacturers must provide clinical evidence to support
their clinical claims, including: diagnostic sensitivity (clinical sensitivity)
and diagnostic specificity (clinical specificity).
5. Labels of medical device
This is the descriptive and informational product
literature that accompanies the medical device, such as: any physician/user
manuals, pack labeling. This section must summarize, refer to or include the
following labeling data to the extent appropriate to the complexity and risk
class of the medical device, which is generally considered as “labeling”:
● Labels on the medical device and its packaging;
● User manual;
● Any information and instructions given to the
patient, including instructions for any procedure the patient is expected to
perform (if applicable).
5.1 Label samples on the medical device and its
packaging
Label samples including information on the product
must be presented in print, text or images, provided or attached to one or more
layers of packaging, including secondary packages and primary packages. If it
is impossible to provide physical label samples (e.g. a large warning label
attached to an X-ray machine), the information may be provided in an
alternative form, such as an image or technical drawing.
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The label sample must include all products stated
in the application for marketing authorization. In case the application is
submitted according to the medical device family, a label sample as a
representative sample with a note of differences between label samples of the
medical device shall be submitted.
5.2 User manual in Vietnamese
The user manual includes instructions for the
physician or end user to use the medical device safely and for its intended
use. The user manual should include indications, contraindications, warnings or
precautions, potential adverse effects, alternative therapies, and conditions
of storage and use to maintain safety and effectiveness of the medical device.
For IVD medical devices, the user manuals include
the following information (if applicable):
- Type and code (if any) of the IVD medical device.
- Uses:
• Detect or measure something;
• Its function (e.g. screening, monitoring,
diagnosis or aid to diagnosis, prognosis, predicting);
• Use of the same medical device (testing machine)
whether it is automated or not;
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• The type of specimen(s) required (e.g. serum,
plasma, whole blood, tissue biopsy, urine);
• Testing population.
- Instructions: the product is used for IVD.
- The intended user (lay person or professional,
etc.);
- The principle of the assay.
- Description of reagents, calibrators, reference
materials, controls and limitations associated with their use (e.g. intended
for use with a specific testing machine only).
- A list of provided materials and a list of
specially required materials that are not provided.
- For IVD medical devices used in conjunction with
other medical devices and/or in combination with non-medical devices or
instruments:
• Information for identifying these devices or
instruments, including important performance characteristics.
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- Special storage conditions (e.g. Temperature,
light, humidity and the conditions under which medical devices are used, if
applicable.
- The in-use stability may include storage
conditions and the shelf life after the first opening; storage conditions and
the stability of working solutions, if applicable. The product's lifespan must
be clearly stated in the user manual.
- If a medical device is provided in a sterile
form, it is necessary to specify that the medical device is sterile, specify
the sterilization method and the handling instructions in the event that the
sterile packaging is damaged prior to use.
- The information that allows users to be informed
about any warnings, precautions, necessary measures to be taken and usage
restrictions for IVD medical devices. This information should include, if
applicable:
• Warning, precautions and/or measures to be taken
in the event that the IVD medical device is damaged or malfunction or
degradation reflected through the change in the external form of the medical
device may affect performance.
• Warnings, precautions and/or measures to be taken
regarding exposure to foreseeable external influences or environmental
conditions, such as external magnetic fields, electricity and electromagnetic
forces, electric discharges, radiation associated with diagnostic or
therapeutic procedures, pressure, humidity, or temperature;
• Warnings, precautions and/or necessary measures
to be taken regarding potential risks during the use of the medical device in
specific diagnosis, evaluation and treatment (e.g., electromagnetic
interference emitted by the device affecting other devices);
• Precautions related to materials incorporated
into the medical device that contain carcinogens, mutagens or substances
harmful to reproduction, endocrine disruptors, or substances that may cause
sensitivity or allergic reactions in patients.
- Conditions for collecting, handling and preparing
specimen.
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- The necessary information to determine when IVD
medical device is properly installed and ready to operate safely and as
intended by the owner, along with the following information, when applicable:
• Details about the nature and frequency of
preventive maintenance and scheduled maintenance, including cleaning or
disinfection;
• Consumables and how to replace them;
• Information regarding the calibration that needs
to be performed to ensure that medical device operates correctly and safely
throughout its life cycle;
• Measures to mitigate risks encountered by
individuals involved in installation, calibration or repair, such as
contaminated surfaces.
- Recommendations on the quality control process
when necessary.
- Instructions on how to retrieve the values
assigned to calibrators and controls, including information for identifying
reference materials and the reference measurement procedures used.
- The process of conducting tests includes
calculating and interpreting results and recommending additional confirmatory
tests if appropriate.
- The analytical performance characteristics, such
as sensitivity, specificity and precision (which is a combination of trueness
and accuracy).
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- Reference range when applicable.
- Information about interfering substances or
limits (e.g., visual evidence of hyperlipidemia or hemolysis, the specimen
storage duration) may affect the execution of the analysis.
- Warnings or precautionary measures to be taken
regarding the disposal of the device, its accessories and consumables used
together with it, if any. This information should include the following
contents, if applicable:
• Hazards related to infection or microorganisms
(e.g., consumables contaminated with substances capable of transmitting
infections of human origin);
• Environmental hazards (e.g., batteries or
radiative materials that emit potentially hazardous radiation);
• Physical hazards (e.g., explosions).
- For IVD medical devices used by lay persons, it
is necessary to advise users to seek the opinions of healthcare professionals
before making any medical decisions.
- References, if applicable.
- The name and address of the owner must be
presented in a recognizable format that allows for the identification of the
owner's information. In cases where the user manual contains information about the
manufacturing facility and origin, this information must include complete
details regarding the name and address of the manufacturing facility.
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6. Risk analysis (written in either Vietnamese
or English)
This section must summarize, refer to or include
the results of the risk analysis. This risk analysis is based upon
international standards or other recognized standards, and is appropriate to
the complexity and risk classification of the medical device.
Results of risk analysis
A list of possible risks for the medical device
shall be provided. Indirect risks from the medical device may originate from
hazards related to the medical device itself, such as moving parts causing long-term
injuries, or from hazards related to the user, such as ionizing radiation from
an X-ray machine. Assessments of these risks in relation to the declared
benefits of the medical device and methods used to reduce risks to an
acceptable level must be presented. Individuals or organizations analyzing
risks must be identified clearly. Techniques used to analyzing risks must be
defined to ensure the appropriateness to the medical device and the risks
involved.
7. Information on manufacture (in Vietnamese
or English)
This section must summarize, refer to or include
documents related to the manufacturing processes, including quality assurance
measures, in accordance with the complexity and risk classification of medical
devices.
7.1 Manufacturer’s information
The names and addresses of the manufacturers
participating in the processes of manufacture and sterilization (including
third-parties).
7.2 Manufacturing process
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If multiple manufacturers are involved in the
manufacturing process to complete a product, it is necessary to clearly state
which activities each manufacturer is involved in.
Legal
representative of the applicant
Signature (full name, title)
Confirmed by seal or digital signature
__________________________
1For products granted a certificate of
marketing authorization in EU countries, the latest grant date may be written
if the initial authorization date is not stated.
APPENDIX
Essential
principles checklist
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Name of the owner of the medical device:
Name of the medical device:
Product code (if any):
Essential
principles
Applicable to
the medical device?
Applied
standards
Documentary
evidence
General requirements
1. Medical devices must be designed and
manufactured so that when they are used under conditions and for the intended
purposes, and with the knowledge and experience of users, they will not cause
damage to health or safety of patients, users or others, provided that any
risks associated with the use of these medical devices for their intended
purposes are acceptable risks when considering benefits for patients and in
accordance with requirements for health and safety protection at a high
level.
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- Identify hazards and associated risks arising
from the use of the medical devices and the foreseeable misuse,
- Eliminate or minimize risks reasonably through
safe design and manufacturing,
- For risks that cannot be eliminated, fully
implement protective measures, including warnings where necessary, and
- Inform users of residual risks.
3. Medical devices must achieve the effectiveness
intended by the medical device owners and must be designed, manufactured and
packaged in a manner suitable for one or more functions within the definition
of a medical device.
4. The technical characteristics mentioned in
Clauses 1, 2 and 3 should not cause adverse effects to such a degree that the
health or safety of patients or users and other persons is compromised
throughout the expected life of the medical devices; when the medical devices
are subjected to the stresses which can occur during normal conditions of use
and have been maintained and calibrated according to the instructions of
medical device owners.
5. Medical devices must be designed, manufactured
and packaged in such a way that their technical characteristics, when used
for their intended purposes, will not be adversely affected during transport
and storage if the transport and storage are carried out in accordance with
the instructions and information provided by the medical device owners
6. Benefits to be gained must outweigh any
undesirable effects for the effectiveness intended.
7. Medical devices require clinical evidence,
appropriate for their use and risk classification, demonstrating that the
devices comply with the respective essential principles. The clinical
evaluation must be conducted.
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8. Chemical, physical and biological properties
8.1 Medical devices must be designed and manufactured
in such a way that requirements for technical characteristics mentioned in
Clauses 1 to 6 of “General requirements” are satisfied. Particular
attention should be paid to:
- The selection of materials to be used, in
particular regarding toxicity, flammability,
- Physical and chemical properties of the
materials to be used,
- The compatibility between the materials to be
used and biological tissues, cells, body fluids, and specimens, taking into
account the intended purposes of the medical devices,
- Reasons for selection of the material, such as
abrasion, hardness and resistance of metal.
8.2 Medical devices must be designed,
manufactured and packaged in such a way that reduces risks caused by
pollutants and residues for patients and relevant persons during transport,
storage and use of the medical devices. Particular attention should be paid
to tissues exposed and to the duration and frequency of exposure during the
transport, storage and use of the medical devices.
8.3 Medical devices must be designed and
manufactured in such a way that they can be safely used with the materials,
substances and gases to which they are exposed during normal conditions of
use or in routine procedures; If medical devices are used for infusion, they
must be designed and manufactured in such a way that they are compatible with
the medicinal products concerned and the action of such drugs is maintained
for their intended use.
8.4 If a medical device contains a substance
that, if it is used separately, could be considered a medicinal product under
the relevant legislation and has the effect of supporting the action of the
medical device on the body, the safety, quality and effectiveness of the
medical device as well as the safety, quality and effectiveness of the combined
medicinal product must be verified. The “medicinal product" referred to
herein includes stable derivatives from human blood or plasma.
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8.6 Medical devices must be designed and
manufactured in a way that minimizes risks posed by inadvertent ingress or
release of substances from the medical devices, taking into account the
nature of the environment in which they are intended to be used.
9. Infection and microbial contamination
9.1 Medical devices and manufacturing processes
must be designed in a way that reasonably and appropriately eliminates or
minimizes risks of infection to any person. The design must:
- Allow for easy handling, and, where necessary:
- Reasonably and appropriately minimize any
microbial leakage and/or microbial exposure during use;
- Minimize the transfer of contamination from
patients, users or other persons to the medical devices or specimens and vice
versa during use.
9.2 Where a medical device is composed of
substances of biological origin, the risk of infection must be reasonably and
appropriately minimized by selecting appropriate sources, sample donors and
substances, and using validated inactivation, conservation, testing and
control procedures, when appropriate. This requirement may not be applicable
to certain in vitro diagnostic medical devices if viral activity and
infectious agents are essential to the intended uses of the devices or if
being removed or inactivated, the effectiveness of such in vitro diagnostic
medical devices will be affected.
9.3 Medical devices made from non-living tissues,
cells and substances of animal origins will be considered to have animal
origin under relevant regulations, and thus be subject to veterinary control
and supervision for the intended use of these tissues. The medical device
owners should maintain information about the geographical origin of animals.
The processing, storage, inspection and handling of tissues, cells and
substances of animal origin must be carried out in a manner that ensures
optimal safety. In particular, the safety related to viruses and other
infectious agents must be achieved by validated methods of removal or
inactivation during the manufacturing process. This requirement may not be
applicable to certain in vitro diagnostic medical devices if other viral
activity and infectious agents are essential to the intended use of the
products or if being removed or inactivated, the effectiveness of such in
vitro diagnostic medical devices will be affected.
9.4 For products made from cells, tissues and
derivatives of bacterial or recombinant origin that are determined to be
medical devices, the selection of sample sources/donors, processing,
preservation, testing and handling of cells, tissues and derivatives of such
origin must be carried out in a manner that achieves optimal safety. In
particular, the safety related to viruses and other infectious agents must be
achieved by validated methods of removal or inactivation during the
manufacturing process. This requirement may not be applicable to certain in
vitro diagnostic medical devices if other viral activity and infectious
agents are essential to the intended use of the products or if being removed
or inactivated, the effectiveness of such in vitro diagnostic medical devices
will be affected.
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9.6 Medical devices labeled as having a specific
microbial state must be designed, manufactured and packaged to ensure that
they remain in that state when placed on the market and remain so during
transport and storage as specified by the medical device owners.
9.7 Medical devices delivered in a sterile state
must be designed, manufactured and packaged to ensure that they remain
sterile when placed on the market and remain sterile under the transport and
storage conditions specified by the medical device owners.
9.8 Medical devices labeled as sterile or as having
a specific microbial state must be processed, manufactured and, if necessary,
sterilized by means of appropriate and validated methods.
9.9 Medical devices intended to be sterilized
must be manufactured in appropriate and controlled conditions (e.g. environment).
9.10 Packaging for non-sterile medical devices
must be capable of keeping the medical devices at the prescribed level of
cleanliness. If medical devices need to be sterilized before use, the
packaging system should minimize the risk of microbial contamination with
consideration taken of sterilization methods of the medical device owners.
Such medical devices must be manufactured in appropriate and controlled
conditions.
9.11 Packaging and/or labeling of medical devices
must be distinguishable from identical or similar products on the market in
both sterile and non-sterile conditions.
10. Manufacturing and environmental properties
10.1 If a medical device is intended to be used
in combination with other medical devices or tools, the whole combination,
including the connection system should be safe and should not impair the
specified effectiveness of the medical devices or tools. Any known
restrictions on use applying to such combinations should be indicated on the
label and/or in the instructions for use.
10.2 Medical devices should be designed and
manufactured in such a way as to remove or reasonably and appropriately
reduce the:
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- Risks connected with reasonably foreseeable
external influences or environmental conditions, such as magnetic fields,
external electrical and electromagnetic effects, electrostatic discharge, pressure,
humidity, temperature or variations in pressure and acceleration;
- Risks associated with the use of the medical
devices when they come into contact with materials, substances or gases, to
which they can be exposed during normal conditions of use;
- Risks from accidental penetration of substances
into the medical devices;
- Risks of incorrect identification of samples;
- Risks of interference with other medical
devices normally used in investigation or treatment;
- Risks arising from failure to maintain or
calibrate (as with implantable devices), from aging of the materials used or
from the loss of accuracy of some measurement or control mechanism.
10.3 Medical devices must be designed and
manufactured in such a way as to minimize the risks of fire or explosion
during normal use or in case of malfunction. Particular attention should be
paid to medical devices whose intended use includes exposure to or use in
association with flammable or combustible substances.
10.4 Medical devices should be designed and
manufactured in such a way as to facilitate their safe disposal of waste
substances.
11. Medical devices with a diagnostic or
measuring function
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11.2 Medical devices shall be designed and
manufactured in such a way as to provide sufficient accuracy, precision and
stability for their intended purpose, based on appropriate scientific and
technical methods. In particular, the design must address sensitivity,
specificity, trueness, repeatability, reproducibility, known confounding
factor control and detection limits, if any.
11.3 Where the operation of medical devices
depends on the use of calibrators and/or controls, traceability of values
assigned to such calibrators and/or controls must be ensured through a
quality management system.
11.4 Any measurement, monitoring or display scale
must be designed in accordance with scientific design principles, taking into
account purposes of the medical devices.
11.5 Whenever possible, values expressed
numerically should be in commonly accepted, standardized units, and
understood by users of the medical devices.
12. Protection against radiation
12.1 General
Medical devices should be designed, manufactured
and packaged in such a way that exposure of patients, users and other persons
to radiation is appropriately minimized in a manner that is compatible with
the intended purpose, whilst not restricting the application of levels for
diagnostic and therapeutic purposes.
12.2 Intentional radiation
12.2.1 Where medical devices are designed to emit
hazardous or potentially hazardous radiation that is visible or invisible to
users for specific medical benefits that outweighs its inherent risks, and
users can control such radiation, these medical devices should be designed
and manufactured to ensure the relevant variable parameters stay within a
tolerance.
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12.3 Unintended radiation
Medical devices should be designed and
manufactured in such a way that the exposure of patients, users and other
persons to the emission of unintended, stray or scattered radiation is
appropriately reduced as far as possible.
12.4 User manual
The operating instructions for medical devices
emitting radiation should contain detailed information as to the nature of
the emitted radiation, the means of protecting the patients and users, and
ways of avoiding misuse and of eliminating the risks during installation.
12.5 Ionizing radiation.
12.5.1 Medical devices emitting ionizing
radiation should be designed and manufactured to ensure that the shape,
quantity and distribution of energy (or quality) of such emitted radiation
can be changed and controlled where possible, taking into account the
intended use.
12.5.2 Medical devices emitting ionizing
radiation intended for diagnostic X-rays should be designed and manufactured
in such a way as to achieve an image and/or output quality that are
appropriate to the intended medical purpose whilst minimizing radiation
exposure of patients and users.
12.5.3 Medical devices emitting ionizing
radiation intended for therapeutic X-rays shall be designed and manufactured
in such a manner as to properly monitor and control doses used, beam types,
energy and, where possible, monitor and control the energy distribution of
radiant beams.
13. Requirements for medical devices
connected to or equipped with an energy source.
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13.2 For medical devices combined with medical
software or being medical software by themselves, such software must be
evaluated on an advanced scientific-technical basis, taking into account the
principles of development life cycle, risk management, evaluation and
verification.
13.3 Medical devices for which the patients'
safety depends on an internal power source must be equipped with a power
status indicator.
13.4 Medical devices for which the patients'
safety depends on an external power supply must be equipped with an alarm
system to signal when power goes out.
13.5 Medical devices intended to monitor one or
more clinical parameters of patients must be equipped with an appropriate
alarm system to alert users to situations that could lead to death or serious
deterioration of the patients' health status.
13.6 Medical devices shall be designed and
manufactured to appropriately minimize as far as possible risks of generating
large amounts of electromagnetism that could impair the operation of the
medical devices themselves or other medical devices located nearby.
13.7 Medical devices must be designed and
manufactured to ensure immunity to electromagnetic interference so that these
devices can function as intended.
13.8 Protection against electrical risks
Medical devices must be designed and manufactured
in such a way that patients or anyone else are protected in the best way
against electrocution accidents when such devices are installed and
maintained in accordance with the owners' instructions, in a normal operating
condition and in a single fault condition (SFC)
14. Protection against mechanical risks
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14.2 Medical devices shall be designed and
manufactured to minimize risks arising from vibrations generated by the
medical devices, taking account of technical progress and of the means
available for limiting vibrations, particularly at source, unless the
vibrations are part of the operation of the devices.
14.3 Medical devices shall be designed and
manufactured to minimize risks arising from the noise emitted, taking account
of technical progress and of the means available to reduce noise,
particularly at source, unless the noise emitted is part of the operation of
the devices.
14.4 Terminals and connectors to user-controlled
electrical, gas, or hydraulic and pneumatic power supplies shall be designed
and constructed to minimize any possible risks.
14.5 Accessible parts of medical devices
(excluding the parts or areas intended to supply heat or reach given
temperatures) and their surroundings should not attain dangerous temperatures
under normal conditions of use.
15 Protection against risks posed to patients by
medical devices supplying energy or substances
15.1 Medical devices for supplying patients with
energy or substances should be designed and installed in such a way that the
rate and/or amount to be delivered can be set and maintained accurately
enough to ensure the safety of patients and users.
15.2 Medical devices should be fitted with means
of preventing and/or indicating any inadequacies in the rate and/or amount of
energy delivered or substances delivered which could pose a danger. Medical
devices should be equipped with suitable means to prevent, as far as
possible, the accidental release of energy or substances at dangerous levels.
15.3 The control and indicator display functions
must be clearly specified on medical devices. Where a medical device bears
instructions required for its operation or indicates operating or adjustment
parameters by means of a visual system, such information should be understandable
to users and, as appropriate, patients.
16. Active implantable medical devices
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- Categories of medical devices;
- The medical device owner;
- Year of manufacture of medical devices.
16.2 That information must be readable without
surgery on transplant recipients.
17. Protection against risks for patients posed
by medical devices for use or testing by lay users
17.1 These medical devices must be designed and
manufactured in such a way as to ensure that they perform appropriately for
their intended purpose, taking into account the skills and the means
available to lay users and the influence resulting from variations that can
be reasonably anticipated in the lay users' technique and environment.
The information and instructions provided by the medical device owners
should be easy for the lay users to understand and apply.
17.2 These medical devices must be designed and
manufactured in such a way as to minimize risks of error during use, and if
applicable, in the handling of testing samples and in the interpretation of
testing results.
17.3 These medical devices should, where
appropriate, include a means by which the lay users can verify that, at the
time of use, the medical devices will perform as intended by the owners.
18. Information provided by medical device owners
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19. Clinical investigation
Clinical investigations conducted on human
subjects must be based on the Declaration of Helsinki. This requirement
covers all steps in a clinical investigation from initial consideration of
the need and justification of the investigation to the publication of
results.
Write “Yes", if such essential principles
are applicable to the medical devices;
Write “No", if such essential principles are
not applicable to the medical devices.
If one essential principle is not applicable to
the medical devices, explanations are required.
E.g. if a medical device does not contain
biological materials, in the column “applicable requirements”, write
"No" and specify that the medical device does not contain
biological materials.
(List the reference standards or internal
standards and procedures that the manufacturer applies to ensure the product
meets the essential principles)
E.g.
- ISO 13485
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- EN ISO 18113-1
- IEC 61326-1
- IEC 61326-2-6
- IEC 60601-1
(state the technical documentation that
demonstrates compliance to the essential principles, E.g. certificates,
investigation reports, test results etc.)
Template
No. 06
Brief
technical description of medical devices serving the issuance of import
licenses
Name of the importing facility (name, address)
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No
Heading
Brief
description
1
Description of medical device
1.1
Prescription of the medical device
Provide brief prescription of operating principles
and features and technical parameters of the medical device; specify that if
the device uses new technologies, a description of such new technologies
(e.g. nanotechnology) should be provided.
1.2
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Make a list of parts and accessories of the
medical device
1.3
Purposes/Indications
Specify purposes/indications of the medical
device
1.4
User manual
Provide brief instructions for use of the medical
device as prescribed in the Instruction sheet or Information sheet of the
medical device
1.5
Contraindications
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1.6
Warnings and precautions
Provide warnings and precautions when using the
medical device, including preventive measures to protect patients from risks
caused by the use of the medical device. They can be warnings about adverse
effects or misuse and precautions
1.7
Adverse effects
Provide adverse effects related to the use of the
medical device that are recorded through clinical tests and after-sales
service which have been previously performed for the medical device
2
Information of the product circulated in
countries (if any)
Provide information on the countries in which the
marketing authorization of the product is granted, or the first country in
which the marketing authorization of the medical device is granted
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Indications that have been registered in other
countries (if any)
Make a list of countries in which marketing
authorization attached with the indications approved in these countries are
granted; dates of issue of the marketing authorization
4
Notable information about the safety/operation of
the medical device:
- Provide information on the number of reports on
adverse effects related to the use of the medical device; measures for
recall/adjustment of after-sales services implemented at the request of
regulatory authorities of some countries;
- Provide the following information if the
medical device contains such components:
● Human or animal cells or tissues or their
derivatives intended for use in a non-viable form – e.g. artificial heart
valves from pig or cat intestines, etc.;
● Cells, tissues and/or derivatives of microbial
or recombinant origin – e.g. skin plumping products based on hyaluronic acid
obtained by bacterial fermentation, etc.; Contain irritating, ionizing
ingredients – e.g. X-ray; or non-ionizing - E.g. laser, ultrasound, etc.
We certify that the above information is true. We
will be responsible before law for the above-mentioned information.
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Legal
representative of the facility
Signature (full name, title)
Confirmed by seal or signature
APPENDIX VIII
TEMPLATE OF REPORT ON RECEIPT, DISPATCH, INVENTORY, USE
OF MEDICAL DEVICES, PRODUCTION MATERIALS, EQA REAGENTS THAT CONTAIN
NARCOTICS/PRECURSORS
(enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the
Minister of Health)
FACILITY’S NAME
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
No. ……
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REPORT ON
RECEIPT, DISPATCH, INVENTORY, USE IN ............
OF MEDICAL DEVICES AND EQA REAGENTS THAT CONTAIN NARCOTICS/PRECURSORS
To: .…………….………………………
No.
Name of medical device/ production material/ EQA
reagent
Number of declaration
Narcotic/ precursor
Name of narcotic/ precursor
CAS code
Content in a smallest packing unit
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Remaining quantity of the previous period
Received quantity
Used1
Dispatched quantity
Remaining quantity at the end of the current period
Loss 2
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This report is enclosed with the detailed list of
names and addresses of customers, and names and quantity of narcotics/
precursors dispatched in the year.
…………..,
day……..month……….year ……
Legal representative of the facility
Signature (full name, title)
Confirmed by seal or signature
_________________________
1 Specify quantity of production
materials.
2 Including the quantity of destroyed
products and expired products, etc. If any, a detailed report is required
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