  
  
G/TBT/N/CHN/1600  
30 April 2021  
(21-3703) Page: 1/1 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  CHINA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  National Medical Products Administration  
Name and address (including 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 
Devices; (HS: 90); (ICS: 11)  
5. Title, number of pages and language(s) of the notified document:  Regulation on 
Medical Device Business Supervision and Management Measures (22 page(s), in Chinese)  
6. Description of content:  This document is the regulation on strengthening the 
supervision and administration and standardizing the business activities of Medical 
Devices within the territory of China.  
It contains 89 Articles in 6 Chapters including business licensing or filing, q uality 
management of the business, supervision and legal liability, etc.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of deceptive practices and consumer protection; Protection of 
human health or safety  
8. Relevant documents:  - 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
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:   
WTO/TBT National Notification and Enquiry Center of the People's Republic of China  
Tel: +86 10 57954633 / 57954627  
Email: tbt@customs.gov.cn  
https://members.wto.org/crnattachments/2021/ TBT/CHN/21_3181_00_x.pdf  
 