G/TBT/N/CHN/1724  
11 April 2023  
(23-2568) 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:  CHINA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
State Administration for Market Regulation (Standardization Administration of the P.R.C.)  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notific ation shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Active 
implantable medical devices (HS code(s): 902150; 902190); (ICS code(s): 11.040.40)  
5. Title, number of pages and language(s) of the notified document:  National 
Standard of the P.R.C., Implants for surgery — Active implantable medical devices — Part 
1: General requirements for safety, marking and for information to be provided by the 
manufacturer; (42 page(s), in Chinese)  
6. Description of content:  This document specifies the requirements that are generally 
applicable to active implantable medical devices.  
This document applies not only to electrically powered active implantable medical devices, 
but also to active implantable medical devices powered by other energy sources(e.g., gas 
pressure or springs).  
This document also applies to certain non -implantable parts and accessories of active 
implantable medical devices.  
NOTE 1  
For particular types of active implantable medical devices, these general requirements 
are supplemented or modified by the requirements of particular parts of the document.  
The tests that are specified in this documents are type tests and are to be carried out on 
samples of an active implantable medical device to show compliance.  
NOTE 2  
The device that is commonly referred to as an active implantable medical device can be 
a single device, a combination of devices, or a combination of a device or devices and one 
or more accessories. Not all of these parts are required to be either partially or totally 
implantable, but there is a  need to specify some requirements of non -implantable parts 
and accessories if they could affect the safety or performance of the implantable device.  G/TBT/N/CHN/1724  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human  health or safety; Protection of the environment; Quality 
requirements  
8. Relevant documents:   
- 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  24 months after approval  
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  
E_mail: tbt@customs.gov.cn  
https://members.wto.org/crnattachments/2023/TBT/CHN/23_8860_ 00_x.pdf