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THE MINISTRY
OF HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.: 30/2015/TT-BYT
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Hanoi, 12
October 2015
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CIRCULAR
ON IMPORT OF MEDICAL EQUIPMENT
Pursuant to the Commercial Law dated 14/6/2005;
Pursuant to Decree No. 187/2013/ND-CP
dated 20/11/2013 of the Government detailing the implementation of Commercial
Law on trading of international goods and activities of trading and processing
agents and goods transit with foreign countries;
Pursuant to Decree No. 63/2012/ND-CP
dated 31/08/2012 of the Government defining functions, duties, powers and
organizational structure of the Ministry of Health;
At the request of the Director of Department
of Medical Equipment and Health Facilities;
The Minister of Health issues the Circular
providing for the import of medical equipment.
Chapter I
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Article 1. Scope of
regulation
1. This Circular defines the authority, dossier
and procedures for issue of import Permit of 100% brand new medical equipment
(hereafter referred to as the import Permit) included in the List specified in
Annex 1 issued with this Circular.
2. The import of medical equipment in the form
of foreign aid (including medical equipment of over 80% quality), temporary
import and re-export, temporary export and re-import, border transfer of goods,
medical equipment as movable property, in service of personal needs with
diplomatic status and personal luggage shall comply with the provisions of
Decree No. 187/2013/ND-CP dated 20/11/2013 of the
Government detailing the implementation of the Commercial Law on trading of
international goods and activities of trading and processing agents and goods
transit with foreign countries and the guidelines of the Ministry of Industry and
Trade.
Article 2.
Interpretation of terms
In this Circular, the terms below are construed
as follows:
1. Medical equipment is the types of equipment,
tool, material and in-vitro diagnosis chemical and software used separately or
combined with each other as indicated by the owner to serve people for one or a
lot of purposes as follows:
a) Diagnosis, prevention, monitoring, treatment
and mitigation of disease or injury compensation;
b) Checking, replacement, modification or
surgery support and physiological process;
c) Life support or sustainment;
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dd) Sterilization of medical equipment (not
including chemicals and insecticides and disinfectants for domestic and medical
use);
e) Use for medical equipment;
g) Special transport for
medical activities.
2. In-vitro diagnostic chemical includes the
reagent, diagnostic chemical, cleaning solution used for medical equipment
(in-vitro diagnostic biologicals excluded)
3. Manufacturer is the unit carries out the
design, production, assembly, packaging and labeling the medical equipment
before provided.
4. Distributor is any organization or individual
in foreign countries authorized by the owner to distribute n the medical
equipment.
5. Medical equipment owner (hereafter
referred to as owner) is any organization or individual directly implementing
or permitting other organizations or individuals to use his/her name to provide
the medical equipment in his/her own name or any label, design, commercial name
or other names or other codes under the ownership or control of such
organizations or individuals and shall take responsibility for the design,
production, assembly, label, packaging, or maintenance, repair of medical
equipment or define a purpose of use for such medical equipment.
Article 3. Principles for
issue of import Permit
1. The issue of medical equipment import Permit
only applies to the imported medical equipment included in the List specified
in Annex 1 issued with this Circular.
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Chapter II
AUTHORITY, DOSSIER AND
PROCEDURE FOR NEW ISSUE, RENEWAL, MODIFICATION, RE-ISSUE AND REVOCATION OF
MEDICAL EQUIPMENT IMPORT PERMIT
Article 4. Authority
of new issue, renewal, modification, re-issue and revocation of medical
equipment import Permit
The Minister of Health shall decide the new
issue, renewal, modification, re-issue and revocation of medical equipment
import Permit
Article 5. Forms of issue of
medical equipment import Permit
1. The new issue of medical equipment import
Permit is applied in case such medical equipment is requested for issue of
medical equipment import Permit for the first time or the medical equipment
import Permit has expired without renewal as stipulated in Clause 1, Article 13
of this Circular.
2. The renewal of medical equipment import
Permit is applied in case the medical equipment has been issued with the import
Permit.
3. The modification of content of import Permit
is applied to the cases where the import Permit is still valid but its content
has changes. The duration of import Permit must not be modified.
4. The re-issue of medical equipment import
Permit is applied where the import Permit is still valid but it is lost or
damaged.
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1. The written request for new issue of medical
equipment import Permit of the organizations or individuals is under the Form
No.01 specified in Annex 2 issued with this Circular.
2. Valid Certificate of free sale of types of
imported medical equipment at the time of submission of dossier.
3. The valid ISO 13485 or ISO 9001
quality
systems certification (hereafter referred to as ISO Certification) of the
manufacturer at the time of dossier submission.
4. The valid Letter of authorization from
medical equipment owner to organizations or individuals importing the medical
equipment under the Form specified in Annex III issued with this Circular
(hereafter referred to as Letter of authorization) at the time of dossier submission.
5. The technical material describing the types
of medical equipment in Vietnamese language under the Form No. IV issued with
this Circular.
6. Catalogue describing the functions and
technical parameters of types of imported medical equipment.
7. The clinical assessment material and manual
of owner or manufacturer for the medical equipment specified in section 49 of
Annex I issued with this Circular.
8. Report on result of import of medical
equipment by the time of dossier submission for new issue of medical equipment
import Permit in case where the import Permit has expired without renewal as
stipulated in Clause 2, Article 5 of this Circular. The report on result of
import of medical equipment is under the Form specified in Annex 6 issued with
this Circular.
Article 7. Dossier for
renewal of medical equipment import Permit
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2. The valid Certificate of free sale of types
of imported medical equipment at the time of dossier submission.
3. The valid ISO certification of the medical
equipment manufacturer at the time of dossier submission.
4. The valid letter of authorization at the time
of dossier submission.
5. The report on result of import of medical
equipment by the time of dossier submission for renewal of medical equipment
import Permit is under the Form specified in Annex 6 issued with this Circular.
Article 8. Dossier for
modification of medical equipment import Permit
1. The dossier for modification from the
manufacturing firm or country of medical equipment:
a) The written request for modification of
import Permit from organizations or individuals importing the medical equipment
is under the Form 03 specified in Annex II issued with this Circular;
b) The valid Certificate of free sale for types
of medical equipment with the added contents for modification from the
manufacturing firm or country of medical equipment at the time of dossier
submission;
c) The valid ISO Certification from manufacturing
firm or country of medical equipment.
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a) The written request for modification of import
Permit from the organizations or individuals importing the medical equipment is
under the Form 03 specified in Annex 2 issued with this Circular.
b) The technical materials describing the type
of imported medical equipment in Vietnamese is under the Form specified in
Annex 4 issued with this Circular and the Catalogue describing the functions
and technical parameters of the type of imported medical equipment in case of
modification of name of medical equipment.
Article 9. Dossier for
re-issue of medical equipment import Permit
The dossier for re-issue of medical equipment
import Permit in case of loss or damage: The written request for re-issue of
import Permit from the organizations or individuals importing the medical
equipment is under the Form No. 04 specified in Annex 02 issued with this
Circular.
Article 10. Requirements
for papers in dossier for new issue, re-issue, renewal and modification of
medical equipment import Permit
1. The dossier for new issue, re-issue, renewal
and modification of import Permit (hereafter referred to as the import dossier)
is made into 01 set as follows:
a) The documents in the import dossier is
clearly printed and arranged in the order specified in Articles 6, 7, 8 and 9
of this Circular with separation between documents, cover page and list of
documents.
b) The import dossier including various types
must have all technical materials describing the types and catalogue of each
type of imported medical equipment.
2. Requirements for Certificate of free sale in
the import dossier:
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b) Where the Certificate of free sale is issued
by the foreign body, before submission as stipulated under Point a of this Clause,
the following requirements must be met:
- If the language used in the Certificate of
free sale is not English or Vietnamese, it must be translated into Vietnamese;
- Consularly legalized
under the provisions of Decree No. 111/2011/ND-CP dated
02/12/2011 of the Government on consular certification and consular
legalization (hereafter referred to as Decree No. 111/2011/ND-CP)
except that the Certificate of free sale is issued by the competent body of the
countries signing the Agreement on mutual legal assistance with Vietnam.
c) Where the Certificate of
free sale of the types of imported medical equipment has no indication of time
limit for expiration, it must be the original issued within 24 months from the
date of issue.
3. Requirements for ISO certification in the
import dossier:
Submission of original or certified copy or copy
with seal of the organization requesting the import or copy with signature of
individual requesting the import. In case of submission of copy with the seal
of organization requesting the import or the copy with signature of individual
requesting the import, provide the additional information related to the ISO
Certificate of the organization issuing the ISO Certificate for comparison.
4. Requirements for letter of authorization:
a) Submission of original or certified copy or
copy with seal of the organization requesting the import or the copy with
signature of individual requesting the import. In case of submission of copy
letter of authorization with the seal of organization requesting the import or
signature of individual requesting the import, there must be the original
presented for comparison.
b) Where the letter of authorization issued by
the foreign body, before submission as stipulated under Point a of this Clause,
the following requirements must be met:
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- Consularly legalized
under the provisions of Decree No. 111/2011/ND-CP except
that the Certificate of free sale is issued by the competent body of the
countries signing the Agreement on mutual legal assistance with Vietnam.
5. For the Catalogue describing the functions
and technical parameters of types of imported medical equipment:
Submission of original or certified copy or copy
with seal of the organization requesting the import or the copy with signature
of individual requesting the import. In case of submission of copy with the
seal of organization requesting the import or signature of individual requesting
the import, there must be the original presented for comparison.
Article 11. Receipt of
dossier for new issue, renewal or re-issue of import Certificate
1. The organizations or individuals requesting
the new issue, renewal or re-issue of import Certificate (hereafter referred to
as the importing unit) shall submit their dossier at the Ministry of Health
(Department of Medical Equipment and Health Facilities).
2. After receiving the dossier, the Ministry of
Health shall issue the importing unit the Receipt of dossier. The time to
receive the dossier for issue of medical equipment import Permit is from the
date indicated on the seal of receipt of incoming official letters of the
Ministry of Health.
Article 12. Procedure for
new issue of import Certificate
1. Within 05 working days from the date
indicated in the Receipt, the Ministry of Health shall review the completeness
and validity of dossier for new issue of import Permit.
2. In case the dossier is complete and valid, the
Ministry of Health shall hold a meeting of its consultation Council for issue
of medical equipment import Permit (hereafter referred to as the consultation
Council) for review and opinions to the dossier for new issue of import Permit
within 10 working days from the date indicated in the Receipt.
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Based on the such minutes, the Minister of
Health shall consider and decide the issue of medical equipment import Permit
and reply in writing in case of disapproval for issue.
b) Where the consultation Council requires
modification or addition of dossier:
- Within 05 working days from the date of
minutes of consultation Council, the Ministry of Health must give a written
notice to the importing unit for modification or addition of importing dossier.
The written notice should specify which document needs addition or modified
contents. The notice of dossier completion is done only one time except for the
case of contents which the Ministry of Health has given the notice of
completion but the unit requesting import has failed to complete them or
improperly as required by the Ministry of Health.
- When receiving the written requirement for
modification or addition of import dossier, the importing unit must modify or
add it in accordance with the contents specified in the written requirement and
send such dossier to the Ministry of Health. The date of receipt of modified or
added dossier is specified on the seal of receipt of incoming official letters
of the Ministry of Health and shall be processed as stipulated in Clause 1 and
Point a, Clause 2 of this Article.
- Where the importing unit has modified or added
the import dossier but improperly with the requirement, the Ministry of Health
shall notify the importing unit for further completion of importing dossier as
stipulated in Clause 1 and 2 of this Article.
- In case of requirement for modification or
addition of import dossier but after sixty (60) days after the Ministry of
Health gives a written notice of modification or addition of import dossier but
the importing unit fails to comply with such requirement, the Ministry of
Health shall refuse to further review such dossier.
3. In case of incompletion or invalidity:
a) Within 10 working days from the date recorded
on the Receipt, the Ministry of Health shall give a written notice to the
importing unit for modification or addition of import dossier. The written
notice must specify which document or content needs modification. The notice of
dossier completion is done only one time except for the case of contents which
the Ministry of Health has given the notice of completion but the unit
requesting import has failed to complete them or improperly as required by the
Ministry of Health.
b) When receiving the written requirement for
modification or addition of importing dossier, the importing unit must carry
out the modification or addition in accordance with the contents specified in
the written requirement and send the modified or added dossier to the Ministry
of Health. The date of receipt of modified or added dossier is specified on the
seal of receipt of incoming official letters of the Ministry of Health
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d) If there is no more requirement for
modification or addition of import dossier, the Ministry of Health shall issue
the new import Permit in accordance with the provisions under Point a, Clause 2
of this Article.
4. In case of requirement for modification or
addition of import dossier but after sixty (60) days after the Ministry of Health
gives a written notice of modification or addition of import dossier but the
importing unit fails to comply with such requirement, the Ministry of Health
shall refuse to further review such dossier.
Article 13. Procedures for
renewal or modification of import Permit
1. The time limit for submission of dossier for
renewal or modification of import Permit:
a) The dossier for renewal and modification of
import Permit must be submitted to the Ministry of Health at least 15 working
days before its expiration. The time to submit the dossier is from the date of
submission recorded on the Receipt;
b) After the time limit specified under Point a
of this Clause, if wishing to be issued with the import Permit, the importing
unit must request the issue of new import Permit.
2. Within 05 working days from the date recorded
on the Receipt, the Ministry of Health shall review the completion or validity
of dossier for renewal or modification of import Permit.
3. Where the dossier is complete and valid, the
Ministry of Health shall renew or modify the import Permit within 10 working
days from the date recorded on the Receipt.
4. Where the dossier is not complete and valid:
Comply with the provisions in Clause 3, Article 11 of this Circular.
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Article 14. Procedure for
re-issue of import Permit
Within 05 working days from the date recorded on
the Receipt, the Ministry of Health shall re-issue the import Permit.
Article 15. Consultation
Council for issue of medical equipment import Permit
1. The consultation Council for issue of medical
equipment import Permit is established under the decision of the Ministry of
Health is responsible for:
a) Giving advice to the Minister of Health of
the technical professional issues related to the imported medical equipment;
b) Reviewing and giving opinions about the
dossier for issue of medical equipment import Permit before submission to the
Minister of Health for decision.
2. Providing assistance to the consultation Council
is the secretary Group including the specialists of Department of Medical
Equipment and Health Facilities.
Article 16. Validity of
medical equipment import Permit
The validity of medical equipment import Permit is
until the validity of the letter of authorization and up to 01 year from the
date of signature and issue.
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The unit importing the medical equipment shall
pay the fees for new issue, renewal, modification and re-issue of import Permit
at the Ministry of Health as prescribed by law on fees and charges.
Article 18. Revocation of
medical equipment import Permit
1. The cases of revocation of medical equipment
import Permit:
a) The importing unit forges the dossier for
issue of medical equipment import Permit;
b) Organizations or individuals modifies or
erases for change of content of medical equipment import Permit;
c) The importing unit has terminated its operation
or no longer authorized by the owner or medical equipment manufacturer without
transfer of import right to the replacing organization;
d) The medical equipment circulated in the
market has defects causing adverse effect to the health of users with impossible
remedy.
dd) The medical equipment import Permit has been
issued beyond the authority or with improper dossier or procedure as prescribed
by this Circular.
e) The medical equipment whose circulation
duration is over according to the notice of the manufacturer or owner of
medical equipment or competent authorities.
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a) During the examination or inspection, if
detecting any breach specified in Clause 1 of this Article, the unit performing
the examination or inspection shall make a record and send it to the Ministry
of Health;
b) Within 05 working days after receiving the
record specified under Point a of this Clause, the Ministry shall review and
decide the revocation of medical equipment import Permit. The revocation
Decision is posted on the website of the Ministry of Health and sent to the
customs authorities and organizations or individuals responsible for import.
3. After having the revocation Decision of
medical equipment import Permit, the importing unit shall revoke the imported
medical equipment specified in the revocation Decision and stop the import of
such equipment.
Chapter III
IMPLEMENTATION
PROVISION
Article 19. Effect
1. This Circular takes effect from 30/11/2015.
2. The Circular No. 24/2011/TT-BYT
dated 21/06/2011 of the Minister of Health guiding the import of medical
equipment shall be invalidated from the effective date of this Circular.
Article 20. Transitional
provision
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2. The medical equipment import Permits issued
under the Circular No. 24/2011/TT-BYT dated 21/06/2011 of
the Minister of Health guiding the import of medical equipment are still used
until the end of validity recorded in the Permit.
3. For the medical equipment not included in the
List specified in Annex 01 issued with this Circular have been issued with the
import Permit, it shall be imported without the import Permit from the
effective date of this Circular.
Article 21. Implementation
responsibility
Director of Department of Medical Equipment and
Health Facilities, Chief of ministerial Office, Chief of ministerial Inspector,
Director General of Departments or General Departments under the Ministry of
Health; Director of Departments of Health and other relevant organizations or
individuals are liable to execute this Circular.
Any problem arising during the implementation of
this Circular should be reported to the Ministry of Health (Department of
Medical Equipment and Health Facilities) for review and settlement./.
FOR THE
MINISTER
DEPUTY MINISTER
Nguyen Viet Tien
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ANNEX 1
LIST OF MEDICAL EQUIPMENT WITH REQUIRED IMPORT
PERMIT
(Issued with Circular No. 30/2015/TT-BYT dated 12/10/2015 of
the Minister of Health Issued with Circular No.
30/2015/TT-BYT dated 12/10/2015 of the Minister of Health)
No.
Product
description
Code
Diagnostic equipment
1.
X-ray imaging diagnostic equipment
9022.12.00
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9022.14.00
2.
Magnetic resonance system
9018.13.00
3.
Ultrasonic diagnostic scanner
9018.12.00
4.
Endoscopic diagnostic system
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5.
Cyclotron System
9022.90.90
6.
Diagnostic equipment with radioactive isotopes
(PET, PET / CT, SPECT, SPECT / CT system, iodine concentration equipment I130, I131)
9022.12.00
7.
Automatic refractometer
9018.50.00
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Electrophysiology machine (EEG machine, ECG machine, electro-mechanical machine)
9018.11.00
9018.19.00
9.
Retinal power meter
9018.50.00
10.
Oosteoporosis meter
9018.12.00
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11.
Retinal scanners / fundus fluorescence scanner
9018.50.00
12.
Ultrasonic fetal heart detector
9018.12.00
13.
Respiratory function meter/analyzer
9018.19.00
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Biochemical analyzer
9027.80.30
15.
Electrolyte and blood gas analyzer
9027.80.30
16.
Hematology analyzer
9027.80.30
17.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
9027.80.30
18.
Erythrocyte sedimentation rate meter
9027.80.30
19.
Elisa Elisa test system
9027.80.30
20.
Blood group analyzer
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
21.
Cell extraction unit
9027.80.30
22.
Platelet aggregation and functional analysis meter
9027.80.30
23.
Bacteria and virus identifier
9027.80.30
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Immunological analyzer
9027.80.30
25.
Reagents, diagnostic chemicals, cleaning
solution used for medical equipment
3006.20.00
3822.00.10
3822.00.20
3822.00.90
Treatment equipment
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
X-ray treatment equipment
9022.14.00
27.
Endoscopic surgery system
9018.90.90
28.
Radiotherapy equipment (Cobalt machine for cancer
treatment cobalt, linear accelerators for cancer treatment, gamma scalpel of
various kinds, brachytherapy equipment of various kinds
9022.21.00
29.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
9018.19.00
30.
Infusion pump, electric injection pump
9018.31.90
31.
Scalpel (high-frequency, laser,
ultrasound)
9018.90.30
32.
Surgical microscopes
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
33.
Equipment system for prostate surgery
9018.90.30
34.
Cardiopulmonary bypass
machine
9018.90.30
35.
Positioning equipment in surgery
9018.90.30
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Cryosurgery equipment
9018.90.30
37.
Infant incubator, infant heater
9018.90.30
38.
Anesthesia machine/with ventilator
9018.90.30
39.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
9019.20.00
40.
Cardiac defibrillators, pacemaker
9018.90.30
41.
High-pressure oxygen chamber
9019.20.00
42.
Extracorporeal lithotripsy system/endoscopic lithotripsy
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
43.
High-intensity ultrasound equipment
system for tumour treatment
9018.12.00
44.
Dialysis equipment
9018.90.30
45.
Ophthalmologic surgery system (Excimer Laser,
Femtosecond Laser, Phaco, vitreous cutter, corneal flap microkeratome)
9018.50.00
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Eyeglasses, contact lenses (near-sighted, far-sighted,
astigmatism) and preservative solution of contact lenses
9004.90.10
47.
Laser treatment machine used in ophthalmology
9018.50.00
48.
Types of permanent implant equipment and
material (over 30 days) in the body
90.21
3006.40
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
49.
Types of interventional equipment and material
in the body of cardiological and cranial nerve specialty
90.21
In case of dispute related to the application
of HS code in the list, the Ministry of Health and Ministry of Finance (General
Department of Customs) shall consider and agree on the code.
Note: Annually, the Ministry of
Health (Department of Medical Equipment and Health Facilities) shall review,
modify, add and update the List of Annex 01 to create favorable conditions for
the importing units and in accordance with the reality in management of import
of medical equipment.
ANNEX II
FORM OF APPLICATION FOR ISSUE OF MEDICAL EQUIPMENT
IMPORT PERMIT
(Issued with Circular No. 30/2015/TT-BYT dated 12/10/2015 of
the Minister of Health)
Form No.01 – Application for new issue of
medical equipment import Permit
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Form No.03 – Application for modification of
medical equipment import Permit
Form No.04 – Application for re-issue of medical
equipment import Permit
Form No.01 –
Application for new issue of medical equipment import permit
Name of importing unit
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: ……./…….(*)
(**)………., date ...... month.... year......
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
To: the Ministry of
Health (Department of Medical Equipment and Health Facilities)
Importing unit Importing
unit:
Address:
Tax code:
Tel:
Fax:
Legitimate representative Legitimate
representative:
Contact Tel:
Mobile phone:
Officer in charge of importing activities:
Contact Tel:
Mobile phone:
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
No.
Name of
medical equipment
Model
Firm/country
of manufacture
Firm/country
of owner
Distributing
firm/country (if any)
Year of
manufacture
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Import purpose:
2. Duration of Certificate of free sale:
3. ISO Duration of ISO
Certificate:
4. Duration of Letter of authorization:
5. Commitment of the importing unit:
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Takes responsibility to
warrant the medical equipment and provide chemicals, materials and replacement components during utilization.
- Meets the requirements and conditions about
the contingent of officials responsible for techniques and ensures the
efficiency and safety of medical equipment for the users and environment,
ensures the conditions about facilities and means of transport without effect
on quality of imported equipment; ensures the requirements for label of goods
and equipment in accordance with regulations.
- Ensures the use of imported medical equipment
in accordance with the contents of application and accept the inspection and
examination of competent authorities
We shall take full responsibility before law for
breach of above commitment.
Importing
unit
(Signature, full name and seal)
(*)Abbreviated symbol of
the importing unit
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Form No.02 – Application
for renewal of medical equipment import Permit
Name of importing unit
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: ……./…….(*)
(**)………., date ...... month.... year......
Application for
renewal of medical equipment import Permit
To: Ministry of
Health (Department of Medical Equipment and Health Facilities)
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Address:
Tax code:
Tel:
Fax:
Legitimate representative Legitimate
representative:
Contact Tel:
Mobile phone:
Officer in charge of importing
activities Officer in charge of importing activities:
Contact Tel:
Mobile phone:
Request the renewal of medical equipment import
Permit according to the following list:
No.
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Model
Firm/country
of manufacture
Firm/country
of owner
Distributing
firm/country (if any)
Year of
manufacture
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Issued import Permit No…………dated……..
2. Duration of Certificate of free sale:
3. Duration of ISO Certificate:
4. Duration of Letter of Authorization:
5. Reasons for renewal:
6. Attached documents:...............
We undertake to fully and properly comply with
regulations of law of the State and the Ministry of Health on import of medical
equipment and shall take full responsibility before law for any breach.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Importing unit
(Signature, full name and seal)
(*) Abbreviated symbol of the
importing unit
(**) Name of
province/city where the importing unit’s head office is located
Form No.03 –
Application for modification of medical equipment import Permit
Name of importing unit
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
(**)………., date ...... month.... year......
Application
for modification of medical equipment import Permit
To:
Ministry of Health (Department of Medical Equipment and Health Facilities)
Importing unit:
Address:
Tax code:
Tel:
Fax:
Legitimate representative:
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Officer in charge of importing
activities:
Contact Tel:
Mobile phone:
Request the modification of medical equipment
import Permit according to the following list:
No.
Name of
medical equipment
Model
Firm/country
of manufacture
Firm/country
of owner
Distributing
firm/country (if any)
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Issued import Permit No…………dated……..
2. Duration of Certificate of free sale:
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
4. Duration of Letter of Authorization:
5. Reasons for modification:
6. Attached document:............................................................................
I/we undertake to fully and properly comply with
regulations of law of the State and the Ministry of Health on import of medical
equipment and shall take full responsibility before law for any breach.
Importing unit
(Signature, full name and seal)
(*) Abbreviated symbol of the
importing unit
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Form No.04 –
Application for re-issue of medical equipment import Permit
Name of importing unit
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: ……./…….(*)
(**)………., date ...... month.... year......
Application
for re-issue of medical equipment import Permit
To:
Ministry of Health (Department of Medical Equipment and Health Facilities)
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Address:
Tax code:
Tel:
Fax:
Legitimate representative:
Contact Tel:
Mobile phone:
Officer in charge of importing
activities:
Contact Tel:
Mobile phone:
Request the re-issue of medical equipment import
Permit according to the following list:
No.
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Model
Firm/country
of manufacture
Firm/country
of owner
Distributing
firm/country (if any)
Year of
manufacture
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Issued import Permit: No……dated....
2. Reasons for re-issue of Permit:
..........................
3. Attached document: ............................................................................
I/we undertake to fully and properly
comply with regulations of law of the State and the Ministry of Health on
import of medical equipment and shall take full responsibility before law for
any breach.
Importing unit
(Signature, full name and seal)
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
(*) Abbreviated symbol of the
importing unit
(**) Name of province/city
where the importing unit’s head office is located
ANNEX III
FORM OF LETTER OF AUTHORIZATION
(Issued with Circular No. 30/2015/TT-BYT dated 12/10/2015 of
the Minister of Health)
To be printed on company letterhead of the product owner (name,
address)
Date…….
LETTER
OF AUTHORISATION
To: Ministry of Health (Department
of Medical Equipment and Health Facilities)
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
(Products
list: name of medical equipment)
We commit to provide and support all information concerning product information,
product quality upon request from the Vietnam Ministry of
Health (Department of Medical Equipment and Health Facilities) for the medical equipment mentioned above.
This authorization letter is valid
until: …… date (dd/mm/yy)
Legitimate representative of
legal manufacturer (product owner)
Signature
(Full name and title)
ANNEX IV
FORM OF TECHNICAL MATERIAL DESCRIBING TYPE OF
IMPOTED MEDICAL EQUIPMENT
(Issued with Circular No. 30/2015/TT-BYT dated 12/10/2015 of
the Minister of Health)
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: ……./…….(*)
(**)………., date ...... month.... year......
TECHNICAL
MATERIAL DESCRIBING TYPE OF IMPOTED MEDICAL EQUIPMENT
No.
Item
Brief
description
1
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1.1
Description of medical equipment
Brief description of operating principles and
features, technical parameters of the equipment; indicate if the equipment
has the new technologies, eg nanotechnology, provide a description of such
new technologies
1.2
List of components and accessories (including
the accompanying chemical)
List all components and accessories; for
equipment using chemicals, special-use reagents, list the name of such special-use
chemicals and reagents
1.3
Purpose/use indication as specified on the
group
Indicate the estimated purpose/use indication
specified on the label of imported equipment
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Use instructions
Brief instructions on usage of equipment as
indicated in the Manual or information sheet of imported equipment.
1.5
Contraindication
Information about contraindication – that
means the cases of prohibited use of equipment for reason of patient’s safety,
ex: medical history, patient’s physiological characteristics, etc; in
accordance with the contents approved in the country of manufacture and
specified on label of imported equipment.
1.6
Warning and caution
The warning information and the points of
caution upon use of equipment, including the preventive measures to protect
patients to avoid risks from use of such equipment. It may be the warning
information about adverse effect or wrong use and preventive measures.
1.7
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Information about adverse effect related to
the use of medical equipment is recorded through clinical test and post-sale follow-up done before for the imported medical equipment.
2
Information about products circulated in the
countries (if any)
Provide information about the countries
approving and permitting the product circulation, the first country issuing
the registration/permission for circulation of medical equipment.
3
Indication registered in other countries (if
any)
List the countries issuing the circulation
registration with the indication of use approved in such countries; date of
issue of registration.
4
Information about the notable
safety/operation of medical equipment products
...
...
...
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(If the equipment contains one of the
following components, provide information about:
● Cell, animal or human tissue or their derivatives used as not alive -
for example artificial heart valve from pig, catgut…;
● Cells, tissues and or derivatives from micro-organisms or recombinant
- eg skin inflation products based on hyaluronic acid obtained from bacterial
fermentation process ...; There are irritant or ionized ingredients - eg
X-ray; or non-ionizing - ag laser, ultrasound ...
Importing unit
(Signature, full name and seal)
(*) Abbreviated symbol of the importing
unit
(**) Name of
province/city where the importing unit’s head office is located
...
...
...
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ANNEX V
FORM OF MEDICAL EQUIPMENT PERMIT
(Issued with Circular No. 30/2015/TT-BYT dated 12/10/2015 of
the Minister of Health)
MINISTRY
OF HEALTH
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: /BYT-TB-CT
Subject: Issue of medical equipment import Permit
Hanoi, date .. month .. year 201…
To:
Importing unit………
Based on Circular No…....../2015/TT-BYT dated…….of the Ministry of Health stipulating the
import of medical equipment.
...
...
...
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No.
Name of
medical equipment
Model
Country of
manufacture
Firm/country
of owner
Distributing
firm/country (if any)
...
...
...
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The importing unit……….is required to comply with
the current regulations on import of medical equipment and goods labeling and
must take responsibility for the amount, price and quality of imported medical
equipment as prescribed by law.
This import Permit is valid until
date…month….year….
POSITION OF
SIGNER
Signature, full name and seal)
ANNEX VI
...
...
...
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Name of importing unit
-------
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.: ……./…….(*)
(**)………., date ...... month.... year......
REPORT ON
IMPORT OF MEDICAL EQUIPMENT
To:
Ministry of Health (Department of Medical Equipment and Health Facilities)
Importing unit:
Address:
...
...
...
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Tel:
Fax:
Legitimate representative:
Contact Tel:
Mobile phone:
Officer in charge of importing
activities:
Contact Tel:
Mobile phone:
Importing unit....... makes report on importing
activities of medical equipment as follows:
No.
Name of medical
equipment
Model
...
...
...
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Firm/country of
manufacture
Firm/country of
owner
Distributing
firm/country (if any)
Year of
manufacture
Official letter
of issuing import Permit of the Ministry of Health
1
...
...
...
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2
...
...
...
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…
…
...
...
...
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Importing unit
(Signature, full name and seal)
(*) Abbreviated symbol of the
importing unit
(**) Name of
province/city where the importing unit’s head office is located
...
...
...
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