Measures for the Administration of Registration and Filing of Medical Devices

It is an effective supporting measure of the Regulations:

On February 9, 2021, Premier of the State Council. Li Keqiang signed State Council Order No.739, promulgating the new Regulations on Supervision and Administration of Medical Devices. In order to implement the new Regulations, meet the reform  requirements  of the  examination and approval system for medical devices, establish a more scientific supervision and management  system  for  medical devices, and  strengthen the registration  management  of  medical  devices, the  State  Food and Drug Administration organized  the  revision  of the original Administrative  Measures  for  Registration  of  Medical  Devices and  Administrative  Measures  for  Registration  of  in Vitro Diagnostic Reagents.

Examination and approval system reform:

Add a special chapter on special registration procedures, and stipulate the registration procedures for innovative products and the priority registration procedures.

The emergency registration procedures are stipulated, and the inclusion scope and supporting policies of each procedure are defined.

Clear supervision responsibilities:

Improve the relevant provisions on risk control and on-site inspection of clinical trials, and establish a responsibility interview system.

To strengthen the implementation of the main responsibility of medical device registrants and filers, it is required to strengthen the life cycle quality management of medical devices, and take responsibility for the safety, effectiveness and quality control ability of medical devices

in the whole process  of  development ,  production , operation and use according to law.

The “streamline administration, delegate power, strengthen regulation and improve services” reform is simplified.

Simplify the requirements for registration and filing materials such as overseas listing documents and inspection reports.

Adjust the requirements for inspection reports of Class II an Class Ill medical devices, and make it clear that applicants for registration can submit self-inspection reports.

Post time: Oct-15-2021