In order to promote high-quality development of the medical device industry and better meet public health needs, the NMPA has published a draft copy of "Announcement on The Production Transfer of Imported Medical Devices Having Received Registration Certificate”.
This announcement is applicable to all class II and III medical devices, which have China imported medical device certificate, and more specifically to foreign registrants who have investments from Chinese firms. The scope of this scheme is applicable to firms from Hong Kong, Macau and Taiwan registrants, who have establishments in China.
The announcement describes three major parts:
- Scope of application;
- Registration requirements; and
- Other aspects.
Content of the announcement covers “registration applications”, “declaration of materials”, “relevant acceptance”, and “procedure of reviewing and approval”. At the same time, the announcement also puts forward certain requirements for foreign-controlled investment enterprises established by import registrants in China, such as post-marketing surveillance activity.
The announcement also requires that domestic registrants who have obtained a medical device registration certificate apply for a manufacturing license, in accordance to the Medical Device Manufacturing Supervision and Administration Measures. Furthermore, the manufacturers need to ensure that their medical devices meet China standards and NMPA-approved product technical requirements. The manufacturers shall also strengthen the quality management of medical devices throughout the life cycle.