The only medical device law “Regulations for the Supervision and Administration of Medical Devices” is updated again on May 19th,2017 and signed by the premier LI Keqiang as State Council Decree No. 680. The last version, State Council Decree No. 650 was issued and became effective just two years ago.
It is well-known that the China FDA (CFDA) has been working on the medical device regulation update and often issue regulations in a very fast speed in the last two years. However, it is very astonishing for the industry to see that the highest law can be updated twice with only a two-year period.
In the new law, four things are changed:
- The sites for conducting medical device clinical trial are not just limited to those certificated by the CFDA any more. Instead, as long as the sites follow the medical device good clinical practice (GCP) properly, sites can conduct a trial after filing the local provincial FDA and health bureau. The prerequisite condition of the sites and the filing guidelines will be issued in the near future.
- The term of “large medical equipment” is defined. The large medical equipment is the medical devices with complicated operating techniques, large amount of investment, high operation cost, largely effect on medical service cost and listed for special regulations. With regards to setup large medical equipment, health institutions shall follow the allocating plan made by the national Health and Family Planning Commission (NHFPC). The setup of large medical equipment shall comply with the demands in function and clinical services of the health institution. The health institution shall have appropriate technical conditions, supporting facilities, and qualified professional technical personnel. The setup of large medical equipment must be approved by the HFPC above provincial level and the permission license for large medical equipment must be obtained.
- More requirements for health institution where medical devices are used are specified. Health institutions must have the appropriate storage and conditions, must provide training to the users, use the device strictly according to the product manual and operation practices.
- CFDA shall enhance selective inspections in medical device manufacturers, distributors, health institutions. It is not allowed to charge any testing fees or other fess during selective inspections. The cost shall be covered in the governmental finance budget. CFDA above provincial level shall issue medical device quality report according to the inspection results.
Reference: State Council Decree No. 680, http://www.gov.cn/zhengce/content/2017-05/19/content_5195283.htm