The Department of General Affairs of the National Medical Products Administration ("NMPA) has recently issued the Circular on Implementing Measures for the Reform of "Separating Business Licenses from Operating Permits" to Further Advance the Reform of the Medical Device Evaluation, Examination and Approval System (the "Circular").
The Circular stresses the need to fully implement specific measures in the following five aspects that are rolled out for the reform in delinking business licenses from operating permits. The first is shortening the time frame needed for the examination and approval; the second is introducing optimal measures in favor of the medical innovations and the marketing of medical device products urgently needed in clinical treatment; the third is accelerating and optimizing the examination of a quality system to be registered; the fourth is simplifying materials requested for the examination and approval; and the fifth is publicly revealing the examination and approval procedures, acceptance conditions, processing criteria, and the processing progress. Among others, the Circular states that the time frame needed for the examination and approval of an application filed for registering a type of domestically-produced Class II medical device will be adjusted, requiring that the food and drug regulator accepting an application for registering a type of domestically-produced Class II medical device shall make a decision within 14 working days upon receipt of the evaluation opinions.