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MINISTRY OF
HEALTH OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No. 2302/QD-BYT
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Hanoi, August 05,
2024
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DECISION
ON issuance of guidelines for verification of
legal documents included in medical device marketing authorization applications
MINISTER OF HEALTH
Pursuant to Decree No. 95/2022/ND-CP dated
November 15, 2022 of the Government on functions, tasks, powers and
organizational structure of the Ministry of Health of Vietnam;
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. 19/2021/TT-BYT dated
November 16, 2021 of the Minister of Health on templates of documents and
reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021
of the Government on management of medical devices;
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Pursuant to Circular No. 06/2022/TT-BYT dated
August 01, 2022 of the Minister of Health on the list and issuance of numbers
of market authorization for medical devices serving COVID-19 control in case of
emergencies;
Pursuant to Circular No. 10/2023/TT-BYT dated
May 11, 2023 of the Minister of Health on amendments to certain Articles of
Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health
on templates of documents and reports on implementation of Decree No.
98/2021/ND-CP dated November 08, 2021 of the Government on management of
medical devices;
Pursuant to Decision No. 3336/QD-BYT dated July
08, 2021 of the Minister of Health on the issuance of the list of units
evaluating the quality of diagnostic reagents/ in vitro diagnostic medical
devices for SARS-CoV-2 testing;
Pursuant to Decision No. 3165/QD-BYT dated
August 10, 2023 of the Minister of Health on the assignment of responsibilities
for the evaluation and monitoring of the quality of in vitro diagnostic (IVD)
medical devices;
Pursuant to Decision No. 04/QD-BYT dated January
02, 2024 of the Minister of Health on the designation of units responsible for
processing ASEAN Common Submission Dossier Templates for medical devices in accordance
with ASEAN regulations;
Pursuant to Decision No. 981/QD-BYT dated April
16, 2024 of the Minister of Health on the issuance of the list of experts in
verification and ex post inspection of applications for medical device market
authorization numbers;
Pursuant to Decision No. 982/QD-BYT dated April
16, 2024 of the Minister of Health on the issuance of regulations on activities
of experts in verification and ex post inspection of applications for medical
device market authorization numbers;
Pursuant to Decision No. 1842/QD-BYT dated July
01, 2024 of the Minister of Health on the addition of experts in verification
and ex post inspection of applications for medical device market authorization
numbers;
At the request of the Director of the
Infrastructure and Medical Device Administration (IMDA).
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Article 1. “Guidelines for verification of
legal documents included in medical device marketing authorization applications
(hereinafter shortly referred to as "MAAs)" are enclosed herewith.
Article 2. This Decision comes into force
from the day on which it is signed.
Decision No. 3007/QD-BYT dated November 03, 2022 of
the Minister of Health on the issuance of guidelines for verification and ex
post inspection of documents included in MAAs shall be void from the effective
date of this Decision.
Article 3. The Chief
of the Ministry Office; the Director of the IMDA; experts in verification and
ex post inspection of legal documents under Decision No. 981/QD-BYT dated April
16, 2024 of the Minister of Health on the issuance of the list of experts in
verification and ex post inspection of applications for medical device market
authorization numbers, Decision No. 1842/QD-BYT dated July 01, 2024 of the
Minister of Health on the addition of experts in verification and ex post
inspection of applications for medical device market authorization numbers and
amendments (if any); Heads of agencies and units and relevant individuals are
responsible for the implementation of this Decision. /.
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
GUIDELINES
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Article 1. Composition of legal documents
verified by legal experts included in an MAA
1. General principles: Comply with the provisions
of Article 30 of Decree No. 98/2021/ND-CP, Clause 6 of Article 76 of Decree No.
98/2021/ND-CP, which are amended and supplemented by Decree No. 07/2023/ND-CP,
and Article 3 of Circular No. 05/2022/TT-BYT.
2. An MAA shall consist of:
a. A written request for a new market authorization
number.
b. The Certificate of conformity with ISO 13485
quality control standards that is still valid from the submission of the
application.
c. The Letter of authorization made by the medical
device owner that is still valid at the time of application submission (except
in cases where enterprises, cooperatives and household businesses of Vietnam
are medical device owners).
d. Certificate of warranty issued by the medical
device owner, except in cases where the disposable medical device as per the
regulations set by the medical device owner or there is documentation
certifying that there is no warranty.
dd. Certificate of Free Sale (CFS) or Market
Authorization (MA) that is still valid at the time of application submission,
for imported medical devices.
e. For an application for a new number of MA for a
medical device with corresponding national technical regulations:
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g. For an application for a new number of MA for a
medical device that is a measuring instrument whose sample requires approval as
prescribed by the law on measurement:
In addition to the required composition mentioned
in points a, b, c, d and dd above, the legal documents must include “an
unexpired Decision to approve the sample medical device”.
h. For an application for accelerated issuance of a
new MA number for a medical device:
In addition to the required components mentioned in
points a, b, c, and d above, the legal documents must include a "CFS/MA
issued by one of the reference countries stipulated in point a, clause 2,
Article 29 of Decree No. 98/2021/ND-CP" or a " CFS/MA for
imported medical devices and an import license or MA number or a Certificate of
MA registration in cases defined in point b, clause 2, Article 29 of Decree No.
98/2021/ND-CP."
For an application for accelerated issuance of
an MA number for an IVD medical device: In addition to the aforementioned
composition of the application, there must be a Quality assessment
certificate issued by a competent authority of Vietnam for the IVD medical
device, except in the following cases:
- The medical device is included in List A or List
B of Appendix 2 of the European Union Regulation of In Vitro Diagnostic Medical
Devices and has been granted a CFS by one of EU Member States, UK or Switzerland.
- The medical device is included in List A or List
B of Appendix 2 of the European Union Regulation of In Vitro Diagnostic Medical
Devices and has been granted an MA by one of the reference countries.
- The medical device is not included in List A or
List B of Appendix 2 of the European Union Regulation of In Vitro Diagnostic
Medical Devices but has been granted an MA by one of the reference countries.
- The medical device falls under Article 3 of
Circular No. 05/2022/TT-BYT dated August 01, 2022 of the Minister of Health
(Addition to the list of IVD medical devices that do not necessitate quality
assessment by a competent authority of Vietnam specified in point dd clause 3
Article 30 of Decree No. 98/2021/ND-CP):
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a) The United States Food and Drug
Administration (US FDA);
b) Therapeutic Goods Administration (TGA) of
Australia;
c) Health Canada;
d) Ministry of Health, Labour and Welfare (MHLW)
of Japan;
dd) Pharmaceuticals and Medical Devices Agency
(PMDA) of Japan;
e) National Medical Products Administration
(NMPA) of China;
g) Ministry of Food & Drug Safety
(MFDS) of Korea;
h) The member countries of the EU issuing
according to the Regulation (EU) 2017/746 of the European Parliament and of the
Council of 5 April 2017 on in vitro diagnostic medical devices
2. The medical device has been granted an MA
number or MA or import license for commercial purposes in Vietnam, except in
cases where the granted MA number or Certificate of MA registration or import
license has been revoked.
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i. For an application for issuance of a new MA
number under emergency procedures:
In addition to the required composition mentioned
in points a, b, c and d above, the legal documents must include:
- The CFS/MA or Emergency use authorization for
the imported medical device.
- The contract for technology transfer in the
case prescribed in point dd clause 3 Article 29 of Decree No. 98/2021/ND-CP.
- The processing contract in the case prescribed
in point e clause 3 Article 29 of Decree No. 98/2021/ND-CP.
- The Certificate of inspection or certificate
of quality assessment issued by one of the inspection/assessment bodies in the
list published on the Ministry of Health’s website if the medical device falls
in one of the following cases:
+ The medical device is domestically
manufactured.
+ The medical device has been authorized for
placement on the market or emergency use by a competent authority of one of the
EU Member States, UK or Switzerland but is not included in the EUHSC’s list of
common products.
k. For an application for a new number of MA for
another medical device:
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- If the application is submitted on January 01,
2024 or upwards, the application must include the documents specified in points
a, b, c, d and dd above and the following documents:
+ The CSDT (ASEAN Common Submission Dossier
Template) inspection record given by the authority designated by the
Minister of Health, accompanied by the CSDT.
+ The Certificate of quality assessment issued by a
competent authority of Vietnam, if the IVD medical device is a reagent,
calibrator and control.
+ The Report on testing for ingredients and
contents of antibacterial agent given by the entity that has declared its
eligibility to conduct testing in accordance with regulations of law on
management of insecticidal and bactericidal chemicals and preparations for
medical and household use; report on evaluation of biological efficacy of the
product and its side effects on the participants in the evaluation conducted by
the entity that has declared its eligibility to conduct such evaluation in
accordance with regulations of law on management of insecticidal and
bactericidal chemicals and preparations for medical and household use.
Article 2. Principles for verification of legal
documents
1. The verification of legal documents shall comply
with the provisions of Article 31 of Decree No. 98/2021/ND-CP.
2. The verification contents shall comply with the
detailed regulations in Appendix I enclosed herewith.
Article 3. Certificate of quality assessment
issued by a competent authority of Vietnam for in vitro diagnostic medical
devices
1. For IVD medical devices for testing SARS-CoV-2:
The Certificate of quality assessment shall be issued by one of the Institutes,
including: National Institute for Control of Vaccine and Biologicals (NICVB),
National Institute Of Hygiene And Epidemiology (NIHE), Pasteur Institute of Ho
Chi Minh City (PIHCM), Pasteur Institute in Nha Trang, and Tay Nguyen Institute
of Hygiene and Epidemiology (TIHE).
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Article 4. The CSDT inspection record
1. For an IVD medical device: The record shall be
given by NICVB or the entity designated by the Ministry of Health.
2. Medical devices other than IVD medical devices (hereinafter
referred to as “general medical devices”): The record shall be given by the
National Institute of Medical Device and Construction (NIMEC) or a unit
designated by the Ministry of Health.
APPENDIX I
Contents of VERIFICATION OF LEGAL
DOCUMENTS INCLUDED IN MAAS
(enclosed with Decision No. 2302/QD-BYT dated August 05, 2024 of the
Minister of Health of Vietnam)
Heading
Requirements
1. Information on a written request for a
number of MA for a medical device:
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- The written request for an MA number that the
applicant has submitted must fully contain the signature, full name, title,
and confirmation by seal or digital signature of the lawful representative of
the applicant as required, or a person authorized by the lawful
representative of the applicant.
- The information on the submitted written
request must correspond to the information that has been reported on the
software.
Detailed requirements
Examining the application for issuance of MA
number for the medical device
- Determining whether the product is an IVD
medical device or a general medical device.
- The application for a new MA number shall be
made according to the provisions of Article 30 of Decree No. 98/2021/ND-CP.
1.1- Name of the applicant
Required information:
Name of the applicant: …………………………………………………..
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Address: ……………………………………………………………………..
Requirements:
- Information on the applicant must match the
information obtained by entering the TIN on: http://tracuunnt.gdt.gov.vn/
- During operations, if there’s any change in the
information on the applicant that doesn’t match the information obtained by
entering the TIN on http://tracuunnt.gdt.gov.vn/: The applicant shall send a
written notification to the IMDA of the change in information including the
name and address of the applicant, enclosed with the documentary evidence.
The IMDA shall consider the appropriateness of this information during the
processing of the application.
1.2- Lawful representative of the applicant
The legal representative shall be the sole signer
of all legal documents or the sole authorized signer of all legal documents
of the application with the following information: Full name.
The lawful representative of the applicant shall
be the legal representative.
Requirements:
- Examining information on the lawful
representative of the applicant must match the information obtained by
entering the TIN on: http://tracuunnt.gdt.gov.vn/
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1.3- Declarations regarding the proposed medical
device.
- Name of the medical device
- The generic name of the device must be written
in lowercase Vietnamese (do not: write it in all caps, use trade name, brand
name, or include code, model, or combine multiple names of medical devices,
or use English name unless the name cannot be translated into Vietnamese, for
example, “Real-time PCR”, “Catheter”, or commonly used generic name).
- Do not include phrases such as “và...đi kèm”
(“and…. accompanying”), “phụ kiện” (“accessories”), “vật tư” (“supplies”),
“hóa chất” (“chemicals”) in the name of the medical device.
- The name must be consistent with the content
and scope specified in the Certificate of conformity with quality control
standards and the CFS/MA.
- In case the applicant registers a
Family/Kit/System/Cluster of medical devices, the name of medical devices
must conform to the rules for grouping for marketing authorization.
- In case the medical device is registered as
part of a family, the word “family” is not added to before the name of the
medical device. Example: Electric syringe pumps with 3 models are grouped as
a family because they have different sizes. The common name of the family
will be: Electric syringe pump.
- For a general medical device: Refer
to the guidelines in Appendix II enclosed herewith to name the medical device
provided that the its name aligns with the its intended purposes in
healthcare.
- For an IVD medical device: Refer
to the guidelines in Appendix III enclosed herewith to name the medical
device provided that the its name aligns with the its intended purposes in
healthcare.
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- In cases where a trade name is declared, the
name of the medical device must be decided by the owner in accordance with
the provisions of point a, clause 5, Article 2 of Decree No. 98/2021/ND-CP
and must match information on one of the following documents: CFS/MA or label
sample or user manual or technical documentation issued by the owner of the
medical device.
Example: NeuronTM Intracranial Access
System / NeuronTM MAX System
- In cases where trade names are not declared, it
will still be accepted.
- Global Medical Device Nomenclature - GMDN code (if
any)
In cases where a GMDN code is declared, this GMDN
code must match that in the CFS/MA, the product label, or other documentation
certifying the GMDN code information.
- Model:
- The name of the medical device and product code
must not be included in the model.
- For an imported medical device: The declared
model must match that on the CFS/MA (except for the symbols included in the
model such as: ®, TM).
- For a medical device domestically manufactured:
The declared model must match that on the CFS/MA (if any) and the product
label (except for the symbols included in the model such as: ®, TM).
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- In case the models specified on the CFS/MA and
the product label are not consistent with each other but the product codes on
such papers are identical, the applicant may declare two models.
Example:
+ The model specified on the CFS/MA is:
VICRYL (polyglactin 910) Suture
+ The model specified on the label: VICRYL
+ The model declared on the written request
for an MA number: VICRYL (polyglactin 910) Suture (on the label: VICRYL).
- In case a Kit, Family, Cluster or System of
medical devices is submitted: It is required to list the models corresponding
to each product code (if any) and the packaging specifications (if any).
- The models of accessories, software,
components, and raw materials used in the production are not included in the
list of proposed medical devices.
- Product code (if any)
- The declared product code must match that on
the CFS/MA:
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- Declare the corresponding product code of each
model.
- Packing specification (if any)
- The declared information must match that on the
CFS/MA.
- In cases where the packing specification is not
written on the CFS/MA, the declared information must match that on the
product label or the technical documentation issued by the owner of the
medical device (if any).
- The declared packing specification must be
corresponding to the product code.
- If an IVD medical device has no product
code, its packing specification must be declared ( (except for instruments,
machines and equipment).
- Class of medical device
The declared class must match the procedures
selected by the applicant (for example, If the applicant applies for new
MA numbers for other medical devices (imported class C/D IVD medical
devices), the declared class must be IVD medical devices of class C or D, and
cannot be general medical devices of class C or D).
- Uses
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- Name of the manufacturer and address
- The declared information must match the content
on the ISO 13485 of the manufacturer.
- In case the name and address of the
manufacturer written on the ISO 13485 Certificate do not match those on the
CFS/MA (if any), an explanation must be provided by the owner of the medical
device.
- All information on the name of the manufacture,
address and country of origin must be specified.
1.4- Information about the owner of the medical
device:
- Required information: The owner’s name and
address.
- The declared information must match the content
written on the CFS/MA and the Letter of authorization of the owner of the
medical device.
- In case the name and address of the owner
written on the CFS/MA does not match those on the letter of authorization of
the owner, the documentary evidence must be provided by the owner of the
medical device.
- In case the CFS/MA does not contain the name
and address of the owner of the medical device, an explanation must be
provided by the owner of the medical device.
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- Required information: The warranty facility’s
name and address.
- It is required to declare the information
matching with that on the Certificate of warranty, except in cases where the
product is a disposable medical device as per the regulations set by the
medical device owner or there is documentation certifying that there is no
warranty.
1.6 - Information about the marketing
authorization of the medical device
The information on the CFS or MA or import
license or MA number or Certificate of MA registration for commercial use in
Vietnam.
- Number of document
- The number of the CFS or MA (if any).
- The import license number or the MA number or
the number of the certificate of MA registration issued by the Ministry of
Health.
- In case the CFS or MA is not numbered, write
“Not available”.
- Name of the issuing organization
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- Date of issue
- The declared date must match that on the CFS or
MA or import license or MA number or Certificate of MA registration.
- Expiry date
- The declared date must match that on the CFS or
MA or import license or MA number or Certificate of MA registration.
- In case of no expiry date on the CFS or MA or
Certificate of MA registration, it is declared as “indefinite”.
1.7 - Number of declaration of eligibility for
domestic production of medical device
- The declaration number must match that in the
“Kết quả dịch vụ công" (“Public Service Results”) section of the Online
public service system for medical device management.
- The declared name and address of the
manufacturer must match those declared on the written request for a new MA
number.
- The manufacture scope must be consistent with
the registered group/ product.
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2.1. Certificate of conformity with quality
control standards
- Being the Certificate of conformity with ISO
13485 quality control standards.
- The name and address of the manufacturer and
the country of origin must match those written on the written request for an
MA number.
- The scope stated on the certificate must be
consistent with the medical device requiring an MA number.
E.g. For an application for MA for ultrasound
equipment, the Certificate must indicate that the factory manufactures
ultrasound equipment in the scope section.
- The Certificate must be unexpired at the time
of application submission and the applicant is responsible for ensuring that
the Certificate is still valid during the process of verification. In case
the Certificate is expired in the process of verification by the Ministry of
Health, the applicant is responsible for notifying and updating the unexpired
certificate.
- The applicant must submit the original
Certificate or a certified true copy of the Certificate or a copy with
confirmation of the applicant.
- For an imported product: If the certificate is
not made in English or Vietnamese, it must be translated into Vietnamese and
the translation must be certified in accordance with regulations (the
translation must include all information presented on the ISO: Name of the
issuing organization and title of the signer, etc.).
- For a product manufactured domestically: The
applicant shall submit the copy of the Decision issued by the Ministry of
Science and Technology attached to the application to the organization
accessing the conformity (notified body) with ISO 13485 in Vietnam.
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- The Letter of authorization of the medical
device owner must comply with the form of Appendix VI of Circular No.
19/2021/TT-BYT dated November 16, 2021 and include the following information:
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.
This Letter of Authorization is valid until:….
date (dd/mm/yy)
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Legal
representative of the owner
Signature (full name, title)
Confirmed by seal or signature
- The unit issuing the Letter of authorization
must be the medical device owner and must: add its signature (full name,
title) with confirmation by seal or signature.
- Information about the owner on the Letter of
authorization must be consistent with:
+ The information declared on the written request
for an MA number.
+ Information in the CFS/MA. In case of no information
of the owner on the CFS/MA, it is required to have the documentary evidence
provided by the owner.
- The name of the medical device and/or its model
(if any) written on the letter of authorization must match those on the
written request for a new MA number. Medical devices may be listed in detail
or grouped, and it is not mandatory to include product codes in the list.
- For a medical device domestically manufactured:
The owner must submit the original or the certified true copy of the Letter
of authorization. Vietnamese is the mandatory language in the Letter of
authorization and there can be translations into other languages.
- For an imported medical device: The consularly
legalized Letter of authorization or its certified true copy shall be submitted.
Vietnamese and English are the mandatory language in the Letter of
authorization and there can be translations into other languages.
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+ The signature confirmation by the notary or the
consular legalization officer must be appropriate for the signer. In case the
notary provides the signature confirmation, the consular legalization content
must be consistent with the information of the notary.
+ The notarization or consular legalization may
only be carried out after the Letter of authorization has been signed.
- In case the applicant is the medical device
owner (Vietnamese enterprise, cooperative or household business is the owner
of the medical device): It is required to have a document indicating that the
applicant is the medical device owner.
- The Letter of authorization of the medical
device owner must be unexpired at the time of application submission and the
applicant is responsible for ensuring that the Letter of authorization
remains valid during the process of verification.
In case the Letter of authorization is expired in
the process of verification by the Ministry of Health, the applicant is
responsible for notifying and updating the unexpired Letter of authorization.
- Requirements for a number of documents
included in the emergency MAA specified in clause 3 Article 29 of Decree No.
98/2021/ND-CP:
Documents issued by foreign competent
authorities must be consularly legalized. Where a document does not bear
consular legalization: With regard to the Letter of authorization, its
original copy accompanied by confirmation shall be submitted.
2.3 - Certificate of warranty
- The unit issuing the Certificate of warranty
must be the medical device owner.
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Headline (name and address) of the medical device
owner: ………………
………[date] ...................., 20…
CERTIFICATE of warranty
Name: ……………………………………………………………….
Address:…………………………………………………..
As the medical device owner, we confirm that the
facilities named below are eligible for providing warranty services for the
medical device of: .......................
Name of the
medical device
Name of
warranty facility
TIN
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Landline
Mobile phone
…..
Facility 1
Facility 2
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Facility 1
Facility 2
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Facility 3
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Lawful
representative of the owner
Signature (full name, title)
Confirmed by seal or signature
- For a medical device domestically manufactured:
The applicant must submit the original Certificate of warranty or the
certified true copy of the Certificate of warranty.
- For an imported medical device: The consularly
legalized Certificate of warranty or its certified true copy shall be
submitted.
- The name of the medical device and/or its model
(if any) written on the Certificate of warranty must match the name and/or
model of the medical device requiring an MA. Medical devices may be listed in
detail or classified/grouped. Vietnamese is the mandatory language in the
Certificate of warranty and there can be translations into other languages.
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- For a medical device that is not under
warranty: It is required to have a written confirmation by the medical device
owner stating that the medical device is not under warranty. This document is
not required to bear consular legalization. This document may be written in
Vietnamese or English.
CFS or MA or Emergency use authorization for
imported medical device or CFS/MA of one of the reference countries
- The consularly legalized document or its
certified true copy shall be submitted.
In case the CFS/MA and information related to the
consular legalization are not written in English or Vietnamese, they must be
translated into Vietnamese. The translation must be certified in accordance
with regulations of law.
- The document must be issued by a competent
authority and information on the consular legalization must meet the
following requirements:
+ The confirmation with signature by the notary
or the consular legalization officer must be appropriate for the signer. In
case the notary provides the signature confirmation, the consular
legalization content must be consistent with the information of the notary.
+ The notarization or consular legalization is
only provided after the CFS/MA has been granted.
- The document must be unexpired at the time of
application submission (if the CFS/MA does not contain information about
its expiration, it holds indefinite validity).
- The CFS/MA must be unexpired at the time of
application submission and the applicant is responsible for ensuring that the
CFS/MA remains valid during the process of verification. In case the CFS/MA
is expired in the process of verification by the Ministry of Health, the
applicant is responsible for notifying and updating the unexpired CFS/MA.
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a) Name of the authority or organization issuing
the CFS.
b) Number and date of issue of the CFS.
c) Name of the product or goods granted the CFS.
d) Type or group of the product or goods granted
the CFS.
dd) Name and address of the manufacturer.
e) The CFS must clearly indicate that the product
or goods is/are manufactured and permitted for free sale in the market of the
country of origin or the country issuing the CFS.
g) Full name and signature of the CFS’s signer
and seal of the authority or organization issuing the CFS.
- Regarding the MA: It is required to check the
following information:
a) Name of the authority or organization issuing
the MA.
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c) Model of the medical device granted the MA.
dd) Name and address of the medical device owner
or name and address of the manufacturer.
- Name and address of the manufacturer; Name and
address of the owner; Name of the medical device (if any), model, product
code (if any), packaging specification (if any) must match those on the
written request for an MA number. In case the CFS or MA does not contain
information on the owner or the manufacturer, documentary evidence must be
provided by owner.
- The CFS or MA template shall be posted on the
Online public service system for medical device management (reference
section).
- Requirements for a number of documents
included in the emergency MAA specified in clause 3 Article 29 of Decree No.
98/2021/ND-CP:
CFS/MA or Emergency use authorization for
imported medical device specified in point c clause 4 Article 30 of Decree
No. 98/2021/ND-CP must indicate the link for searching information on the
marketing authorization or license for use of the medical device on the
licensing authority’s website and be accompanied by a document providing the
link for searching information of the applicant. The information obtained
from the searching on the website must include at least the following
information in English: name; model; manufacturer or country of origin.
2.6. CFS/MA for imported medical device and
import license or MA number or Certificate of MA registration
- According to the provisions of point b clause 2
Article 29 and point d clause 3 Article 30 of Decree No. 98/2021/ND-CP: These
documents are required to be included in the application for accelerated
issuance of a new MA number for the medical device when the medical device
has been granted the Imported license or MA number or Certificate of MA
registration for commercial use in Vietnam, unless the documents have been
revoked before the effective date of this Decree.
- In particular:
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+ Being the Import license that has been issued
by the Ministry of Health in accordance with the provisions of Circular No.
30/2015/TT-BYT, Circular No. 47/2010/TT-BYT.
+ Being the Certificate of MA registration or MA
number for medical device domestically manufactured that has been granted by
the Ministry of Health in accordance with the provisions of Circular No.
07/2002/TT-BYT, Circular No. 44/2014/TT-BYT.
+ Being the MA number that has been granted under
Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP, Decree No. 98/2021/ND-CP
+ Being the MA number granted under emergency
procedures according to Circular No. 13/2021/TT-BYT.
- Model, product code (if any), packaging
specification (if any) stated on the written request for an MA must be
consistent with those of the product that has been granted a license (the
model and product code or packaging specification); information about
the applicant is not necessarily the same as that of the licensed unit. In
case the granted License does not contain information on the product code or
packaging specification, the applicant shall enclose the documentary evidence
showing that the proposed product has been previously licensed.
2.7. Certificate of quality assessment issued by
a competent authority of Vietnam for IVD medical device:
- The original Certificate of quality assessment
or its certified true copy or its copy with confirmation of the applicant
must be submitted.
- The models, product codes (if any) or packaging
specifications (if any) written on the Certificate of quality assessment must
be consistent with those on the written request for an MA number, CFS/MA and
sample label (the model and product code or packaging specification).
- Notes: List A and List B Appendix 2 of the
European Union Regulation of In Vitro Diagnostic Medical Devices are
enclosed with this Decision in Appendix IV.
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- This agreement is part of the application for
issuance of a new MA number for the medical device under emergency procedures
in the case where the medical device is manufactured domestically in the form
of technology transfer in one of the circumstances specified in points a, b,
c, or d clause 3, Article 29 of Decree No. 98/2021/ND-CP.
- The technology transfer agreement must comply
with the provisions of the Civil Code 2015 and the contents stipulated in Law
on Technology Transfer No. 07/2017/QH14 dated June 19, 2017. Article 23 of
the Law on Technology Transfer stipulates the contents of a technology
transfer agreement, including:
“1. Name of the technology to be
transferred.
2. Technologies to be transferred, products
created by the transferred technology, their quality standards.
3. Transfer of the ownership and/or the right
to use technology.
4. Method of technology transfer.
5. Rights and obligations of the parties.
6. Price and method of payment.
7. Duration and effective date of the
technology transfer agreement.
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9. Technology transfer plan or schedule, and
location.
10. Warranty on transferred technology.
11. Penalty for breach of agreement.
12. Liability for breach of agreement.
13. Dispute resolution authority.
14. Other contents agreed upon by the
parties.”
2.9. - The processing contract in the case
prescribed in point e clause 3 Article 29 of Decree No. 98/2021/ND-CP.
- This contract is part of the application for a
new MA number for the medical device granted under emergency procedures in
the case where the medical device is manufactured domestically in the form of
processing in one of the circumstances specified in points a, b, c, or d
clause 3, Article 29 of Decree No. 98/2021/ND-CP.
- The processing contract is an agreement between
the parties, in which the processor performs work to create products
according to the requirements of the hirer, and the hirer receives the
products and pays for the products as stipulated in Article 11 of the Civil
Code of 2015.
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2.10 - The CSDT inspection record given by the
authority designated by the Minister of Health, accompanied by the CSDT
- The CSDT inspection record:
+ There must be complete information about the
name of the medical device, model, product code (if available) or packaging
specifications (if available), intended use, name and address of the
manufacturer, name and address of the applicant. This information must be
consistent with that stated in the written request for an MA number.
+ The original record or its certified true copy
or its copy with confirmation of the applicant must be submitted.
- Regarding the CSDT: Its copy with confirmation
of the applicant shall be submitted. IN case the CSDT is not written in
English or Vietnamese, it must be translated into Vietnamese. The translation
must be certified in accordance with regulations of law.
APPENDIX II
Rules of naming general medical devices
(enclosed with Decision No. 2302/QD-BYT dated August 05, 2024 of the
Minister of Health)
1. The name of the medical device must be
scientific, clear, consistent with the actual characteristics of the medical
device, appropriate for its intended use in healthcare, and distinguishable
from ordinary goods.
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Inappropriate
name
Appropriate
name
Guidewire
Cardiovascular guidewire
2. The name of a medical device must not
contain certain content as follows (except necessary and common medical terms):
Exclusions in
the name of a medical device
E.g.
Inappropriate
name
Appropriate
name
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0,5 mm blue surgical sutures
Surgical sutures
- Specification
128 to under 256-slice CT scanner system
Computed tomography (CT) system
- Proper nouns, English words (not commonly
used in specialized fields)
“Catheter cắt đốt điện sinh lý tim
lntellaNav” (“lntellaNav Cardiac electrophysiology (EP) ablation catheter”)
“Catheter cắt đốt điện sinh lý tim”
(“Cardiac electrophysiology (EP) ablation catheter”)
- Exclusive terms
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Intraocular Lens (IOL)
- Advertising terms
Smart and multifunctional X-ray machine
X-ray machine
- Assumptions and conceptual terms that have not
been scientifically verified or clinically assessed
Ultrasound equipment for cancer treatment
Ultrasound equipment
- Terms that express or imply that the device can
cure all diseases, exaggerate the indications for use, or present misleading
information
Laser treatment devices for rejuvenation,
whitening, and prevention of skin aging
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- The phrase “various types and sizes”
Spine screws in various types and sizes
Spine screws
3. Some notes regarding the terms commonly
used in the naming of medical devices:
- The term “ngoại vi” (“peripheral”) is used
instead of “ngoại biên” in the naming of medical devices;
- The following words:
+ “Máy” (“machine/device/equipment") is used
for a standalone medical device that can operate independently without the need
for other devices or parts.
+ “Hệ thống” ("system") is used for a
medical device that consists of multiple machines interconnected or a single
machine combined with other components in order to function effectively.
+ “Bộ” (“kit”) is used for implants, instruments,
and materials
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- For a drug-coated medical device, it is necessary
to specify the type of coating drug in the name of the medical device.
- For products that can be used without being
affected by magnetic resonance imaging (MRI) equipment: the phrase "tương
thích MRI" (“MRI safe”) is added after the name of the medical device.
4. Some reference examples on how to name
medical devices.
No
Inappropriate
name
Appropriate
name
1.
Monofilament absorbable sutures, multifilament
absorbable sutures (e.g. Multifilament absorbable sutures, slow-absorbing
surgical sutures, and fast-absorbing sutures, etc.)
Absorbable sutures
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Monofilament absorbable sutures, multifilament
absorbable sutures (e.g. Multifilament synthetic non-absorbable
sutures, non-absorbable surgical sutures, surgical sutures, etc.)
Surgical sutures
(except for products made of steel, they
will be named “Surgical steel sutures)
3.
.... drug-coated
(Coronary angioplasty balloon catheter,
drug-coated)
.... drug-coated…. (specify drug type)
(Coronary angioplasty balloon catheter,
Paclitaxel-coated)
4.
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Peripheral vascular angioplasty balloon catheter
Peripheral angioplasty balloon catheter
5.
Metallic vascular embolization coil system
Metallic vascular embolization coil kit
6.
Therapeutic plasma exchange (TPE) kit;
Plasma exchange (TPE) kit;
Plasmapheresis kit
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Hip replacement system;
Consumable materials used in hip replacement
surgery/hip arthroplasty
Hip replacement kit
8.
“Ống thông cắt đốt bằng nhiệt” (“Thermal
ablation catheter”)
“Catheter cắt đốt bằng nhiệt” (also
“Thermal ablation catheter”)
9.
“Ống thông cắt đốt điện sinh lý tim”
(“Cardiac electrophysiology (EP) ablation catheter”)
“Catheter điện sinh lý tim cho điều trị”
(“Cardiac electrophysiology (EP) catheter for treatment”)
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10.
“Ống thông điện cực tạo nhịp tạm thời”
(“Temporary pacing electrode catheter”)
“Catheter điện cực tạo nhịp tạm thời” (also
“Temporary pacing electrode catheter”)
11.
Pacing leads
Pacing leads in cardiac chambers
12.
Pressure regulators
Adjustable cerebrospinal fluid (CSF) shunt valves
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High-level disinfectant solution for medical
equipment
High-level disinfectant solution for medical
devices
14.
Incubators and radiant warmers;
Infant radiant warmers
Neonatal intensive care unit (NICU)
15.
CT-Scanner System;
Computed tomography scanner;
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CT Scanner system with 256 to under 512 slices
per rotation;
CT Scanner system with greater than or equal to
512 slices per rotation;
Computed tomography (CT) system
16.
Subtraction angiography system;
Ceiling-suspended/floor-mounted one-dimensional
digital subtraction angiography (1D DSA) system;
Ceiling-suspended and ceiling-mounted
two-dimensional digital subtraction angiography (2D DSA) system;
Robotic one-dimensional digital subtraction
angiography (1D DSA) system;
Angiography system
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High-function ventilator;
Invasive ventilator;
Invasive and non-invasive ventilators;
High-frequency ventilator;
Ventilator
18.
Resuscitator;
CPAP Ventilator;
BiPAP Ventilator
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19.
“Máy X-quang di động cánh tay C” (”Mobile
C-arm X-ray Machine”);
“Máy chụp X quang C-arm di động” (“Mobile
C-arm X-ray Machine”)
“Máy X-quang C-arm di động chụp chiếu kỹ
thuật số” (“Mobile C-arm X-ray Machine for digital imaging”)
Mobile C-arm X-ray Machine
20.
“Mạch máu nhân tạo INTERGARD Bạc”
("INTERGARD silver vascular graft”)
Silver-coated synthetic vascular graft
21.
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“Ống hút đơn kênh dùng trong phẫu thuật”
(“Single-use suction catheter used in surgery”)
22.
Lumbar drain
Lumbar cerebral spinal fluid (CSF) drain
23.
“Quả lọc dịch” (“hemodialysis”)
“Quả lọc dịch cho chạy thận nhân tạo” (also
"hemodialysis")
24.
1000 ml bag of washed red blood cells (RBCs);
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Bag of washed red blood cells (RBCs)
25.
Dental implant abutment
Artificial dental abutment
26.
“Van tim cơ học nhân tạo” (“Mechanical
heart valve”)
“Van tim nhân tạo cơ học” (also “Mechanical
heart valve”)
27.
“Van tim sinh học” (“Biological heart
valve”)
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“Van tim nhân tạo sinh học” (also
“Biological heart valve”)
28.
“Xương sinh học nhân tạo” (“Biological
bone”)
“Xương nhân tạo sinh học” (also “Biological
bone”)
APPENDIX III
RULES OF NAMING IVD
MEDICAL DEVICES
(enclosed with Decision No. 2302/QD-BYT dated August 05, 2024 of the
Minister of Health)
A. Specific names for each medical device:
1. Regarding the medical device being a standalone
machine: The name of the medical device must be appropriate for the intended
use of the medical device.
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Product type
(1)
Testing type
(2)
Analysis
parameters / analytes / functions (if any)
(3)
Target analysis
(if any)
(4)
Reagents
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- Regarding microbiological testing/ Flow
cytometric (FC) testing/coagulation testing, etc., specific names may be
used following the following formula in Vietnamese: (Testing for) +
identification/drug resistance/ antibiotic susceptibility
testing/determination of the population of expressing cells/determination of
coagulation time/detection of ...
- Regarding blood glucose tests, pregnancy
tests, and ovulation tests, they can be named according to the rules and
accompanied by common names: Qualitative hCG test strips (Pregnancy test
strips), Quantitative glucose test strips (Blood glucose test strips)
E.g. DNA, RNA,
antigens, IgG antibodies, ALT, GGT, TSH, Cortisol, etc.
E.g. Viruses,
bacteria, genes, etc.
Calibrators
Controls
Test strips / Test
trays / Electrode, etc.
The structure of a name = (1) + (2) + (3) + (4) Or
(1) + (2) + (3) Or (1) + (2) + (4)
The name may be either singular or a combination of
multiple components in each item (e.g. Qualitative and semi-quantitative
testing).
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- “Thuốc thử xét nghiệm định tính kháng
thể IgM kháng SARS-CoV-2” (“Reagent for qualitative analysis of IgM antibodies
against SARS-CoV-2”).
- “Thuốc thử xét nghiệm định lượng HBsAg”
(“Quantitative HBsAg reagents”).
- “Thuốc thử xét nghiệm định tính các tế bào
biểu hiện kháng nguyên CD4” ("Reagent for qualitative analysis of CD4+
cells").
• Examples for the structure of names: (1) + (2) +
(3)
- “Thuốc thử xét nghiệm định lượng GGT”
(“Reagents for quantitative GGT testing”).
- “Thuốc thử xét nghiệm xác định thời gian APTT”
(“Reagents for determination of Activated partial thromboplastin time (APTT)”)
- “Que thử xét nghiệm định lượng 11 thông số
nước tiểu” (“Test strips for quantitative analysis of 11parameters in
urine")
- “Que thử/ Khay thử xét nghiệm định tính βhCG”
(“Test strips/trays for β-hCG Qualitative (QHCG) testing”)
- Controls for quantitative analysis of
hematological parameters (volume, conductivity and light scatter (VCS))
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- “Thuốc thử xét nghiệm định danh nấm men”
(“Reagents for identification of yeasts"),
Notes:
- (3) Analytical parameters / analytes: It
is required to write all parameters / analytes, except in cases where medical devices
are reagents/calibrators/controls that have more than 5 analytical parameters.
For these exceptional cases, it is possible to record the quantity of
analytical parameters, the details of the analytical parameters, or to state
the general parameters. As for medical devices categorized as “Negative
Controls”, it is permissible to name the medical devices in a manner that is
suitable for the testing methodology. E.g.
+ “Que thử xét nghiệm định lượng 11 thông số
nước tiểu” (“Test strips for quantitative analysis of 11parameters in urine
").
+ “Vật liệu kiểm soát xét nghiệm định lượng 15
thông số huyết học” (“Controls for quantitative analysis of 15 hematological
parameters”)
+ “Vật liệu kiểm soát xét nghiệm định lượng 17
thông số sinh hóa” (“Controls for quantitative analysis of 17 biochemical
parameters”)
+ “Vật liệu kiểm soát âm tính cho xét nghiệm
PCR” (“Negative control for PCR testing”)
+ “Vật liệu kiểm soát âm tính cho xét nghiệm
sinh hóa” (“Negative control for biochemical testing”)
- For products that consist of multiple components
within a single packaging unit (also known as a “kit”), but do not contain
sufficient components to perform the test, only the main components are listed
in Section (1) - Product type as follows: reagents / alibrators/
controls. These products are regarded as individual items with unique product
codes
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- For products that contain all the essential
components for conducting tests and are provided in a single kit, only the
phrase "Test Kit" is recorded.
Example 1: For an HIV-1 quantitative molecular
biology test kit including all components necessary to conduct the test
(including: Particles, Lysis reagents, cleaning reagents, elution reagents,
Proteinkinase reagents), its registered name will be: "HIV-1 RNA
quantitative test kit”.
Example 2: For an ELISA test kit that consists
of all the components necessary to conduct a test for qualitative detection of
CMV IgG antibodies (including: Reagents, Conjugated enzymes, Wash buffer,
System washing solution, Controls, Calibrators), its registered name will be:
"Test kit for qualitative detection of CMV IgG antibodies”.
3. For medical devices used for in vitro
diagnostics:
The structure of the
name = IVD + summary of intended use.
E.g. IVD medical devices for activation of
chemiluminescent reaction in immunoassay.
• In the case that a product is used for multiple
purposes: the intended uses of the product shall be specified.
E.g. IVD medical devices for lysis and dilution
in hematological testing.
• In cases where the products are containers of
samples or testing solutions, etc., they shall be named according to
designation and specifications of the product owner based on its intended use.
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- Cuvettes used for immunoassay analyzers
- Cuvettes with stirring rods used for
coagulation testing machines.
- Vacuum blood collection tubes
- Sample containers
B. Names of applications upon grouping
Grouping
methods
Declared name
Family
Name of medical device of the family
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IVD Kit
IVD Kit + Type of test + Analytical
parameters/analytes + Test targets
E.g. “Bộ IVD xét nghiệm định lượng Ferritin”
(“IVD kit for quantitative Ferritin testing”)
System
• Case 1: The system consists of machines or
machines and chemicals, etc. used for multiple tests.
IVD System + Summary of intended use
E.g.
- “Hệ thống IVD nhuộm và kéo lam tự động”
(“Automated IVD Slide Staining and Slide Preparation System”)
- “Hệ thống IVD rửa, ủ và lắc xét nghiệm
ELISA” (“IVD system for washing, incubating and shaking in ELISA testing”)
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• Case 2: Specific target testing system
IVD system + Type of test + Analytical
parameters/analyte/function+ Test target
E.g.
- IVD system for quantitative HbA1c testing
- IVD system for quantitative glucose testing
- IVD system for quantitative testing of 7
blood gas parameters
- IVD system for quantitative testing of
electrolyte substances: Na (Sodium), K (Potassium), Cl (Chloride), Ca
(Calcium), Li (Lithium)
IVD cluster
(Notes:
In order to facilitate the process of processing and ex post inspection, it
is advisable to cluster a maximum of 5 products.
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E.g.
- IVD cluster of Enzymes: ALT/GPT, AST/GOT,
CK, -GT
- IVD Cluster of thyroid functional markers: TSH,
T3, T4, FT3, FT4
- IVD cluster of Histological/Cytological Reagents:
Hemolysis and Leukocyte Fixation.
C. Notes
1. Analytical parameters / Analytes / Analytical
targets: Specify the abbreviated name.
In case the target is the name of a microorganism
or a chemical element, the scientific name shall be recorded.
E.g.
- T3, T4, FT3, FT4, HBsAg, CA 125
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- Zn (Zinc), Cu (Copper), Fe (Iron), Ca (Calcium)
2. Calibrators and controls commonly used for
multiple tests: They must be registered individually or as part of the IVD Kit
as same as the reagents used together.
3. For the Calibrators/Controls that are designed
with multiple concentration levels (level 1, level 2, etc.) or classified as
negatives (control /normal control) or positives (positive control/ abnormal
control).
- The concentration levels/ negative or positive
classification must be included in the names of the medical devices.
- Name of the application = (1) + (2) + (3) + (4)
- The method of grouping (“Kit”: if the medical
devices are recommended for joint use, “Family”: if they meet the requirements
for grouping as part of a family in terms of concentration level).
Specific examples:
+ For Calibrators/controls with multiple
concentration levels:
Model
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Name of the
application
Grouping
CK-MB Control Level 1
Level 1 Controls for quantitative CK-MB Testing
Controls for quantitative CK-MB Testing
IVD Kit/IVD Family
CK-MB Control Level 2
Level 2 Controls for quantitative CK-MB Testing
CK-MB Control Level 3
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+ Examples for Calibrators/ Controls in
qualitative testing:
Model
Name of medical
device
Name of the
application
Grouping
HBsAg
Negative
Control
Negative controls for qualitative HBsAg testing
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IVD Kit
HBsAg
Positive
Control
Positive controls for qualitative HBsAg testing
4. For products containing multiple components
within the same packaging unit and having their own unique product codes, these
products are considered as individual items and are permitted to be grouped as
part of Family/Kit/System/Cluster in accordance with the relevant regulations.
APPENDIX IV
LIST A AND LIST B OF
APPENDIX 2 OF the European Union
Regulation of In Vitro Diagnostic Medical Devices
(enclosed with Decision No. 2302/QD-BYT dated August 05, 2024 of the
Minister of Health)
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- Reagents and test products, including related
calibrators and controls, used for determination of blood types: ABO system, Rh
system (C, c, D, E, e), and Kell system (Kell antigen system).
- Reagents and test products, including relevant
calibrators and controls, used to detect, confirm and quantify markers of HIV
infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C, and D in samples
taken from individuals.
List B:
- Reagents and test products, including relevant
calibrators and controls, used to determine blood types: Duffy antigen system
and Kidd antigen system.
- Reagents and test products, including relevant
calibrators and controls, used to identify abnormal antibodies against red
blood cells.
- Reagents and test products, including relevant
calibrators and controls, used to detect and quantify congenital infections
(rubella, toxoplasmosis) in samples taken from individuals.
- Reagents and test products, including relevant
calibrators and controls, used for the diagnosis of inherited disorders:
phenylketonuria.
- Reagents and test products, including relevant calibrators
and controls, used to identify infections in individuals: cytomegalovirus
(CMV), Chlamydia.
- Reagents and test products, including relevant
calibrators and controls, used to identify the HLA tissue groups (human
leukocyte antigens): DR, A, B.
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- Reagents and test products, including relevant
calibrators and controls and software, specifically designed to assess the risk
of trisomy 21.
- Devices for self-diagnosis, including relevant
calibrators and controls: devices used for measuring blood glucose.