On 21 September 2016, the Department of Medical Device Supervision of the China Food and Drug Administration (CFDA) published the Guidelines to Medical Device Manufacturers for the Quality Control and Release of Finished Products (Draft for Public Comment) (the Guidelines). The comment period expired on 30 September 2016 and the final version of the Guidelines would be issues soon.

The Guidelines is an extension and supplement to the requirements on the quality control requirement under the Quality Management Standards for Medical Device Production (the Standards), last revised by the CFDA on 29 December 2014. Based on the Standards, the Guidelines sets out in greater detail the requirements on quality control with respect to procurement, production and sale of medical devices to be followed by the Chinese medical device manufacturers (the Medical Device Manufacturers).

In particular, the Guidelines requires the Medical Device Manufacturers to implement quality control and inspection procedures in the following three(3) areas:

  1. procurement of key materials, spare parts and components;
  2. production, especially the defined “key process” and “special production process”; and
  3. release of the finished products to the market.

Medical Device Manufacturers are required to apply China’s mandatory national requirements and industry standards in priority if they are different from the international standards and set up and implement data analysis procedure in order to monitor the quality control process closely.

Please note that Medical Device Manufacturers refers to domestic funded enterprises and foreign invested enterprises who are licensed by CFDA to produce medical devices in China. The Guidelines does not apply to foreign manufacturers.

Special thanks to Emma Che for her assistance in drafting this post.