G/TBT/W/569  
 
29 November 2018  
(18-7547) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
CHINA — REGULATIONS FOR THE SUPERVISION AND ADMINISTRATION O F MEDICAL 
DEVICES (ORDER NO. 6 50 OF THE STATE COUN CIL) 
STATEMENT BY THE EUR OPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS  TO TRADE  
14 AND 15  NOVEMBER  2018 
The following communication, dated 22  November 2018, is being circulated at the request of the 
delegation of the European Union . 
_______________  
1.  The European Union would like to reiterate its concerns on the Chinese regula tions regarding 
medical devices notified under G/TBT/N/ CHN/1022 to G/TBT/N/CHN/ 1026 and G/TBT/N/CHN/ 1029 
sent to the Chinese authorities on 23 June 2014 and subsequently raised in the TBT Committee 
meetings.  
2.  The EU would like to refer to its concerns previously raised in the TBT Committee in relation to 
the issue of the clinical trials required for the registration in China for Class II or Class III medical 
devices, the delays in this registration procedure, a nd the requirement to register the medical 
devices in the country of origin.  
3.  The EU maintains its concerns with regard to the unnecessary duplicative clinical trials to be 
conducted in China.  
4.  The four catalogues listing medical devices exempted from clin ical trials published so far by the 
Chinese FDA represent a very small number of medical devices compared with other markets. In 
addition to these catalogues, Article 17 of the Order No. 650 stipulates that "substantially equivalent " 
medical devices may be  exempted from clinical trials. However, in practice, exemption from clinical 
trials based on Article 17 has only been granted for a few medical devices and a very small number 
of in-vitro medical devices.  
5.  The EU would  like to ask again for clarification o f whether the clinical trials would have to be 
performed for class II and III in -vitro diagnostic medical devices on Chinese populations living in a 
Chinese mainland environment, and whether results of testing on Chinese populations living abroad 
or on non -Chinese populations would not be accepted. The EU kindly requests China to provide 
clarification on this issue; in particular whether data from clinical trials abroad are sufficient.  
6.  The EU would like to once more request a transitional period of three y ears for the 
electromagnetic compatibility (EMC) testing to be carried out in internationally accredited 
laboratories. The EU would also like to ask China to issue guidelines detailing the relevant processes 
for the EMC testing. To date China did not clari fy whether these issues have already been addressed.  
7.  The EU would like to point out once more that the implementation of Order No. 650 of China's 
Ministry of Finance and National Development and Reform Commission removing the administrative 
fees for medica l device registration testing has led to an immediate and negative impact on the 
availability of testing services critical to the registration process.  
8.  Many labs no longer guarantee timelines for the completion of testing nor accept product testing 
respons ibilities that involve domestic or overseas travel for on -site testing in the manufacturer's G/TBT/W/569  
 
- 2 - 
 
  home city or country. This leads to significant increase of costs and delays in the registration process 
for new products.  
9.  The EU would appreciate receiving inform ation from the Chinese government about the 
development, publishing, and other related implementing measures of announced regulation 
allowing for acceptance of in -house testing reports, and 3rd party testing reports, as a response to 
the backlog caused by the the cancellation of testing fees.  
10.  The EU appreciates the intentions of the Chinese government to reduce expense and complexity 
within the regulatory system. The EU would like to bring the unexpected negative consequences to 
China's attention in the ho pe that a solution can be found to the benefit of regulators, manufacturers, 
and patients who depend on advanced medical technology.  
__________