G/TBT/N/CHN/1723  
11 April 2023  
(23-2566) 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); (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 i mplantable medical devices — Part 
2: Cardiac pacemakers; (55 page(s), in Chinese)  
6. Description of content:  This document specifies requirements for cardiac pacemakers.  
This document applies to those active implantable medical devices intended to treat 
bradyarrhythmias and devices that provide therapies for cardiac resynchronization.  
This document also applies to some non -implantable parts and accessories of the devices.  
The tests that are specified in this document are type tests, and are to be carried o ut on 
samples of a device to show compliance.  
The electrical characteristics of the implantable pulse generator or lead are determined 
either by the appropriate method detailed in this particular document or by any other 
method demonstrated to have an accuracy equal to, or better than, the method spec ified. 
In case of dispute, the method detailed in this particular document applies.  
NOTE  
The device that is commonly referred to as an active implantable medical device can in 
fact 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 performa nce of the implantable 
device.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Protection of the environment; Quality 
requirements  G/TBT/N/CHN/1723  
 
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  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_8859_00_x.pdf