Technical Review

China CMDE.NMPA registration technical review report – Composite Plate System

Recently, China CMDE.NMPA published registration technical review report of composite plate system. Product name: Composite Plate System Product category: Class III Applicant name: CarboFix Orthopedics Ltd. Product structure and composition: This product consists of bone plates and bone screws. The bone plate is made of carbon fiber polyetheretherketone composite material. The material grade is PEEKPEEK-OPTIMA …

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China CMDE Technical Review 2023 Annual Report

China CMDE released its annual report of 2023. Some of the important data is as follows: 1.Submissions Overview 2.Emergency review 3.Time Spent for Review Application Type Product Classification Average Review Time Average expert consultation time Average Supplement time Total Time Initial Registration Class II 72 0 259 332 Class III 98 1 173 274 Class …

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Total 67 Guidance Documents Were Issued by CMDE in the year 2023

In the year 2023, China CMDE issued 67 guidance documents to help technical review and application submission preparation. The following is a list of the guidance documents: No. Guidance 1 Guidance for Registration Review of Novel Coronavirus (2019-nCoV) Antigen Detection Reagent (2023 No. 2) (2023-03-02) 2 Guidance for Registration Review of Novel Coronavirus (2019-nCoV) Antibody …

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Medical deivce consulting company

Summary of medical device technical review work in July 2023

The CMDE implements the decisions and deployments of the Party Central Committee, the State Council and the bureau’s party group, and conducts technical review, pre-review of supplementary materials, medical device technical consultation, approval of some administrative approval items, registration certificate number and data circulation, etc. in accordance with functions and procedures. various tasks. Status of …

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14 Medical Device Product Registration Review Guidelines Released

In order to further standardize the management of medical devices such as blood melting equipment, the Center for Device Evaluation of the State Food and Drug Administration organized and issued 14 guidelines for the registration and review of medical device products including the “Guidelines for the Registration and Review of Blood Melting Devices”: 1. Guidelines …

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Announcement of the NMPA on the release of documents such as the “Requirements for the File Review of Medical Device Product Registration Items”

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 …

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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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