Writing Specification For Periodic Risk Evaluation Report Of Medical Devices (NMPA No.46 2020)(Final)

1.RECITALS

In order to guide and standardize medical device registrants and filers (hereinafter referred to as registrants) to write Periodic risk evaluation reports, this specification is formulated in accordance with the Administrative Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices ( No.1 Order of the State Administration for Marketing Regulation and the People’s Republic of China) (hereinafter referred to as the Measures). The registrant mentioned in this specification has the same connotation as the holder of medical device marketing license mentioned in the Measures. This specification is a technical document guiding medical device registrants to draft and write periodic risk evaluation reports, and it is also an important basis for medical device adverse event monitoring institutions to evaluate periodic risk evaluation reports.

As a guiding document in principle, this Specification is formulated based on the current understanding of periodic risk evaluation reports and puts forward general requirements for writing. However, the actual situation is diverse, and it is difficult to cover all aspects. Specific issues not covered by this Specification should be studied and determined from reality. At the same time, with the accumulation of experience of medical device registrants summarizing medical device safety information regularly, the change of regulatory requirements, and the continuous development of science and technology, this specification will be adjusted in due course.