  
  
G/TBT/N/CHN/1410  
13 March 2020  
(20-1986) 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:  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 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
electrical equipment; Instruments and appliances used in medical, surgical, dental or 
veterinary sciences, including scintigraphic apparatus, other electro -medical apparatus and 
sight-testing instruments (HS 9018); Medi cal equipment (ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  National 
Standard of the P.R.C., Medical Electrical Equipment —Part 1: General Requirements for 
Basic Safety and Essential Performance (313 page(s), in Chinese)  
6. Description of content:  This part is applicable to medical electrical equipment and 
medical electrical system. This part specifies general requirements for basic safety and 
basic performance of medical electrical equipment and medical electrical system.  
7. Objective and rationa le, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements  
8. Relevant documents:   
- 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  36 months after adoption  
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 57954630 / 57954627  
E_mail: tbt@customs.gov.cn  
https://members.wto.org/crnattachments/2020/TBT/CHN/20_1917_00_x.pdf  
 