G/TBT/W/488  
 
19 April 2018  
(18-2429) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 CHINA — REGULATIONS FOR THE SUPERVISION AND ADMI NISTRATION OF MEDICA L 
DEVICES (ORDER NO. 6 50 OF THE STATE COUN CIL) 
STATEMENT BY THE EUR OPEAN UNION TO THE C OMMITTEE ON TECHNICA L BARRIERS TO TRADE  
21 AND 22 MARCH 2018  
The following communication, dated 16 April 2018, is being circulated at the request of the 
delegation of the European Union .  
 
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1.  The European Union would like to reiterate its concerns on the Chinese regulations regarding 
medical devices notified under CHN/1022 to 1026 and 10 29 sent t o the Chinese authorities on 
23 June 2014 and subsequently raised in recent TBT Committees.  
2.  The EU would like to refer to its concerns raised during the last meetings of the Committee in 
relation to the issue of the clinical trials required for t he registration in China for Class II or Class 
III medical devices, the delays in this registration procedure, and the requirement to register the 
medical devices in the country of origin.  
3.  The EU maintains its concerns with regard to the unnecessary dupli cative clinical trials to be 
conducted in China.  
4.  So far, the C hinese FDA has published four catalogues with  medical devices exempted from 
clinical trials – the first  list with 567 devices in August 2014,  the second one  with an additional 359 
devices in Se ptember 2016 , the third one  - covering  only 28 devices – was published for public  
consultation in May 2017 , and on 31.10.2017. a fourth  list of 164 medical devices exempted from 
clinical trials has been released.  This is still a very  small number 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  only a few medical devices and  a 
very small number  of in-vitro medical devices  (around 131 out of the total 1118 devices are in -
vitro medical devices) . 
5.  The EU would like to ask again for  a clarification 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 population would not be accepted. As China was not in the position to 
fully answer these questions during the last Co mmittee meeting, the EU asks  China again for 
further clarification on this issue; in particular whether data from clinical trials abroad are 
sufficient.  
6.  The EU  also reiterated the request for China to continue accepting electromagnetic 
compatibility (EMC) testing carried out in internationally accredited laboratories and remove the 
requirement for in -country  testing. The EU once more asks  China to grant a transi tional period of 
three years and to issue guidelines detailing the relevant processes.  
7.  In relation to the implementation of Order No. 650 the EU has noticed  that China's Ministry of 
Finance and National Development and Reform Commission recently cancelled administrative fees G/TBT/W/488  
 
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  in an effort to reduce cost and complexity to manufacturers but that this has had a negative effect 
on resources for medical device registration testing.  
8.  The goal of the government in issuing the Notice to alleviate the cost burden plac ed on 
enterprises from fees associated with administrative approvals is an important one and well worth 
pursuing. However, the implementation of this policy has resulted in an immediate and negative 
impact on availability of testing services critical to th e registration process.  
9.  Many labs have indicated they will no longer guarantee timelines for completion of testing nor 
will they accept product testing responsibilities that involve domestic or overseas travel for on -site 
testing in the manufacturer's home  city or country. This will lead to significant increase of costs 
and delays in the registration process for new products.  
10.  At the meeting of the DG GROW -CFDA working group on medical devices on 20 November 
2018 CFDA informed about its intention to issue ne w regulation allowing for acceptance of i n-
house testing report s as well as 3rd party testing report s, as a response to the backlog caused by 
the the cancellation of  testing fee s. However, no specific timetable for adoption of this regulation 
could be revealed at the meeting. The EU would appreciate information from the Chinese 
government about the development and publishing of this regulation, as well as other related 
implementati on measures  or guidelines . 
11.  The EU appreciates the intentions of the Chinese government to reduce expenses and 
complexity within the regulatory system. The EU would like to bring the unexpected negative 
consequences to China's  attention in the hope that a s olution can be found to the benefit of 
regulators, manufacturers, and patients who depend on advanced medical technology.  
 
 
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