G/TBT/N/VNM/205  
16 August 2021  
(21-6231) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  VIET NAM   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Department of Medical devices and Construction  
Ministry of Health  
Number 138A, Gi ảng Võ Str, Ba Đình District, Hà N ội, Vietnam  
Tel: (84 -24) 62732272  
Fax: (84 -24) 62732279  
Email: dmec@moh.gov.vn  
Name and address (incl uding telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
equipment (ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  Draft Decree on 
management of medical devices (64 page(s), in Vietnamese)  
6. Description of content:  This draft Decree specifies regulations on the management of 
medical devices, including: classification; manufacturi ng, circulating, trading, exporting, 
importing and providing medical devices services; information, advertising, labelling; 
declare prices of medical devices and manage and use medical equipment at medical 
facilities.  
1. Medical devices that has been manuf actured in Vietnam or imported into Vietnam 
before the effective date of this Decree may continue to be sold until it is liquidated 
according to the provisions of Clause 1, Article 22 of the Law on Management and Use of 
State Property or by the expiration of the time limit stated in the Certificate of Circulation 
of Registration.  
2. The issuance of circulation registration numbers for domestically produced medical 
devices or medical devices that is an in vitro diagnostic biological product shall comply 
with current law provisions with the following validation:  
a) For domestically produced medical devices, which has been granted a certificate of 
free sale, the free -sale registration number is valid until the expiration of the time 
stated on the cer tificate of circulation registration.  
b) For medical devices that is an in vitro diagnostic biological product, which has been 
granted a certificate of circulation in accordance with the 2005 Law on Pharmacy and 
guiding documents on the implementation of t his Law, the issued free -sale registration 
number shall be valid until the end of the time stated on the certificate of circulation 
registration.  G/TBT/N/VNM/205  
 
- 2 - 
 
  c) Imported medical devices that is an in vitro diagnostic biological product submitted 
before December 31, 20 21, shall be granted an import license in accordance with the 
Law on Pharmacy 2005 and is valid until the end of 31 December 2022;  
3. Class B medical devices that has been granted a free -sale registration number before 
the effective date of this Decree sha ll be valid for an indefinite period.  
4. Applications for circulation registration submitted before 1 January 2022 must comply 
with the provisions of Articles 34 and 35 of this Decree.  
5. Labels of medical devices that have been manufactured in Vietnam or imported into 
Vietnam before the date specified in Clause 2 of this Article may continue to be used until 
the expiry of the useful life of the equipment or until it is liquidated according to the 
provisions of Clause 1, Article 22 of the Law on Management and Use of State Property 
or by the expiration of the time limit stated in the Certificate of Circulation of Registration.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Quality requirements  
8. Relevant documents:   
Decree No. 36/2016/NĐ -CP dated on May 15, 2016 of the Government on management 
of medical devices;   
Decree No. 169/2018/NĐ -CP dated on Dec 31, 2018 of the Government on amending 
Decree No. 36/2016/NĐ -CP; 
Decree number 03/2020/NĐ -CP dated on Jan  1st, 2020 of the Government on amending 
Article 68 of Decree No. 36/2016/NĐ -CP. 
9. Proposed date of adoption:  18 October 2021  
Proposed date of entry into force:  1 January 2022  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Department of Medical devices and Construction  
Ministry of Health  
Number 138A, Gi ảng Võ Str, Ba Đình District, Hà N ội, Vietnam  
Tel: (84 -24) 62732272  
Fax: (84 -24) 62732279  
Email: dmec@moh.gov.vn  
https://members.wto.org/crnattachments/2021/TBT/VNM/21_5213_00_x.pdf