G/TBT/W/556  
 
9 July 2018  
(18-4299) 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  
20 AND 21  JUNE 2018 
The following communication, dated 9 July 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 102 9 sent to 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 th e 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 duplic ative clinical trials to be 
conducted in China.  
4.  So far, the Chinese 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 Sep tember 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 w ith 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 ha s 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 w ould 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 b e accepted. As China was not in the position to 
fully answer these questions during the last Committee 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 transit ional 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 a dministrative fees G/TBT/W/556  
 
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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 place d 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 the  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 new  regulation allowing for acceptance of in -
house testing reports as well as 3rd party testing reports, as a response to the backlog caused by 
the the cancellation of testing fees. However, no specific timetable for adoption of this regulation 
could be revea led 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 
implementation measures or guidelines.  
11.  The EU appreciates the intentions of the Chinese go vernment 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 solution can be found to the benefit of 
regulators, manufacturers, and patients  who depend on advanced medical technology.  
 
 
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