Guidelines

Notice on Public Solicitation of Opinions on 3 Medical Device Registration Review Guidelines including “Guidelines for Clinical Evaluation and Review of the Same Type of Absorbable Surgical Sutures (Draft for Comment)”

According to the relevant requirements of the State Drug Administration’s 2022 medical device registration review guidelines formulation and revision plan, the Center for Device Evaluation organized the compilation of 3 medical device registration reviews including the “Guidelines for the Clinical Evaluation and Registration Review of Absorbable Surgical Sutures of the Same Variety” The Guiding Principles …

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Guidelines for filling in application materials for classification and definition of medical devices

1. Purpose In order to implement the relevant requirements of the State Food and Drug Administration for the management of medical device classification, guide the applicants for the classification and definition of medical devices to fill in the application materials and supplementary materials (hereinafter referred to as the application materials), according to the “General Office …

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Key Points of Technical Review of Laparoscopic Surgical System

In order to further standardize the management of laparoscopic surgery systems, the CMDE organized the revision of the “Key Points for Technical Review of Laparoscopic Surgery Systems” (2023 revision), which is hereby released: Key Points of Technical Review of Laparoscopic Surgical System(2023 revision) This review point is intended to guide registration applicants in the preparation …

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Guidelines for Medical Device Registration Review in 2023 Prepare Plan

Formulation plan for guiding principles for registration review of Class III medical devices In order to further strengthen the guiding role of the guiding principles for medical device registration review in the registration application and technical review work, the CMDE organized and drafted a compilation plan for the guidelines for medical device registration review, which …

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