NMPA issues the Announcement on the Requirements for Filing Review of Registration Items of Medical Device Products (Interim)

As per the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of Review & Approval System to Encourage Innovation in Drugs and Medical Devices (General Office [2017] No. 42), in conjunction with the roll out of electronic application of medical device registration, according to the Provisions for Medical Device Registration (former CFDA Decree No. 4) and the requirements of other documents, NMPA organized the formulation of the Requirements for Filing Review of Registration Items of Medical Device Products (Interim), which has been released on July 10, 2019, and shall enter into force as from September 1, 2019. 

The NMPA Center for Medical Device Evaluation shall examine the dossiers of the corresponding applications in accordance with the requirements for filing review in the case-acceptance process, to judge the integrity, compliance and consistency of the application dossiers entering the technical review process. The filing review does not analyze the rationality and adequacy of product safety and effectiveness evaluation, and does not judge the product risk benefit ratio. It is applicable to applications such as medical device registration, licensing alterations, and clinical trial approval.