New regulations for customized medical devices in China

On July 4^th, NMPA issued “customized medical device supervision and management regulations (Trial Version) (NMPA order No. 53 2019)” implemented from January 1^st, 2020. The target of the regulations is to meet the clinical personalized demands and ensure the effectiveness and safety of customized medical devices.

The requirements for the medical device manufacturers:

1. Professional and technical personnel required for the development and production of customized medical devices;

2. Have customized medical device development capabilities and research foundation;

3. Have the same type of medical device registration certificate and corresponding manufacturing license for mass production according to the standard specifications (the overseas production enterprise shall hold the enterprise qualification certificate issued by the competent authority of the medical device in the country where the registration or production address is located);

4. Have the same type of production capacity and production experience of mass-produced medical devices according to standard specifications, and comply with the corresponding quality management system.

Medical device manufacturers should work with medical institutions (clinics, hospitals etc.) as the co-applicants for customized medical device filing, and should filing the record to local FDA before producing or using customized medical devices. Customized medical devices only be provided to the filed medical institutions for the particular patients. Customized medical devices must not be commissioned to be manufactured by a third-party manufacturer.

CIRS Comments

This is the first regulation for customized medical devices. Medical device customization is the trend to future personalized treatment. The domestic and overseas medical device manufacturers who are able to produce customized medical devices should carefully understand the regulation and penetrate in the market in advance.