The Department of General Affairs of the National Medical Products Administration ("NMPA") has recently issued the 2019 Programs for Enactment and Revision of Medical Device Industry Standards and also distributed a circular to clarify arrangements for relevant work.
The 2019 Programs for Enactment and Revision of Medical Device Industry Standards outline a total of 93 programs which include "formulating a standard for freezers for medical use", "amending the standard for intradermal needling" and "amending the General Technical Specifications for Medical Diagnostic X-ray Equipment". For each scheduled program, details about the suggested nature of the standard, the specific responsible technical committee or the responsible entity, and which entity will undertake the program, are clearly provided. According to the circular, the medical device standardization technical committee or the responsible entity that will undertake the task of enacting or amending a standard shall ensure effective work on the organization of the standard drafting process, verification, consultation, and technical examination, seek extensive opinions and improve the communication and coordination with related parties, in order to ensure the technical contents of each standard are scientific, reasonable, feasible and compliant with requirements set out in relevant policies.