In order to further deepen the reform of the review and approval system and encourage the innovation of medical devices, in accordance with the “Administrative Measures for Registration and Filing of Medical Devices” (State Administration of Market Regulation Order No. 47), “Administrative Measures for Registration and Filing of Administration Order No. 48), “Announcement of the State Drug Administration on Publishing the Requirements for Application Materials for Registration of Medical Devices and the Format of Approval Documents” (No. 121 of 2021), “Announcement of the State Announcement on Application Dossier Requirements and Format of Approval Documents” (No. 122, 2021) and “National Drug Administration’s Announcement on Matters Concerning the Implementation of the “Measures for the Administration of Registration and Filing of Medical Devices” and “Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents” ” (2021 No. 76) and other relevant requirements, the State Drug Administration organized a comprehensive revision of the current “Medical Device Product Registration Item File Review Requirements (Trial)” and other documents.
The Medical Device Technical Evaluation Center of the State Drug Administration shall review the application materials of the corresponding application in accordance with the revised filing review requirements during the acceptance process, and conduct a review on the completeness, compliance and consistency of the application materials entering the technical review process. judge. The file review does not analyze the rationality and adequacy of the product safety and effectiveness evaluation, and does not judge the product risk-benefit ratio. The filing review is applicable to application matters such as medical device registration, change of licensing items, and approval of clinical trials.