Latest News

Preparation of the “Guidelines for Registration and Review of Dengue Virus NS1 Antigen Detection Reagents” and “Guidelines for Registration Review of Helicobacter Pylori Resistance Gene Detection Reagents”.

CMDE, Latest News / By

China CMDE is starting the preparation of the “Guidelines for Registration and Review of Dengue Virus NS1 Antigen Detection Reagents” and “Guidelines for Registration Review of Helicobacter Pylori Resistance Gene Detection Reagents”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with …

Preparation of the “Guidelines for Registration and Review of Dengue Virus NS1 Antigen Detection Reagents” and “Guidelines for Registration Review of Helicobacter Pylori Resistance Gene Detection Reagents”. Read More »

Four Guidelines for Registration Review were released by CMDE.NMPA

CMDE, Guidelines, Guiding Principles, Latest News / By

On March 18, 2024, China CMDE.NMPA released four medical device registration review guidelines: 1.“Guidelines for registration review of Corneal topography”, 2.“Guidelines for registration review of Laparoscopic surgery system – Part 2: Animal study necessity analysis and protocol design requirements”, 3.” Guidelines for Registration Review of Laparoscopic Surgical Systems Part 3: Three-Dimensional Endoscopy”, 4.” Guidelines for …

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Preparation of “Guideline for Registration and Review of Human T Lymphocytic Leukemia Virus Antibody Detection Reagents”

CMDE, Guidelines, Guiding Principles, Latest News, NMPA, NMPA News, Others / By

CMDE is starting the preparation of the “Guideline for Registration and Review of Human T Lymphocytic Leukemia Virus Antibody Detection Reagents” and “Guideline for Registration and Review of Human Leukocyte Antigen (HLA) Gene DNA Typing Detection Reagents”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research …

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Medical Device Registration and Licensing Information in China Province

Latest News, NMPA / By

As of January 31, 2024，the medical device registration and licensing information in China provinces is as follows: No. Provinces Domestic medical device products Medical Device Manufacturing Medical device Distribution On-Line Sales Filing Third-Party Platform for Medical Device Sales Registration Registration License（pcs） Filing（pcs） Permit（pcs） Filing（pcs） Permit （pcs） Filing（pcs） 1 Beijing 8124 4087 770 671 2883 43808 …

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The Accredited laboratories List for GB 9706.1-2020 and YY 9706.102-2021

Announcement, Latest News, NMPA News / By

Till January 8,2024, China National Institutes of Food and Drug Control has issued 1000+ CMA Certificates related to 75 PCS of newly released GB 9706 series and YY 9706 Series Standards. The Accredited laboratories List for GB 9706.1-2020 and YY 9706.102-2021 are released at the same time. This is to help the manufacturers to conform …

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China CMDE Releases Draft of Guideline for Comments 

CMDE, Draft for Comments, Guidelines, Latest News / By

On January 23, 2024, CMDE publicly sought opinions on the “Guideline for the Technical Review of the Registration of Phacoemulsification and Vitrectomy Devices and Accessories in Ophthalmology (Revised 2023).”  This guideline aims to assist registration applicants in standardizing the preparation and writing of registration application materials for ophthalmic phacoemulsification and vitrectomy devices and accessories. It …

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Batch of Innovative Medical Devices Undergoes Special Review Process 

Announcement, CMDE, Latest News / By

Document Number: No. 1 of 2024  On January 22, 2024, the China CMDE announced that seven innovative medical devices, including the cardiac pulse electric field ablation system of Insight Lifetech Co., Ltd., and the interventional ventricular assist system of Xinqing Medical (Suzhou) Co., Ltd., have entered the special review process.  Special Instruction: Entry into the …

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The China CMDE has released a draft of the Guideline for the Registration review of Monkeypox Virus Nucleic Acid Detection Reagents 

CMDE, Draft for Comments, Guidelines, Latest News / By

Date Issued: January 18, 2024  This guideline outlines the essential criteria for monkeypox virus nucleic acid detection reagents. Applicants must assess the applicability based on the specific characteristics of their product. If the guideline is not applicable, it is imperative to provide rationale and the corresponding scientific basis. Additionally, applicants should enhance and refine the …

The China CMDE has released a draft of the Guideline for the Registration review of Monkeypox Virus Nucleic Acid Detection Reagents  Read More »

The China CMDE issued guideline for real-world research design and statistical analysis of medical devices

Announcement, CMDE, Guidelines, Latest News / By

Document Number：No. 3, 2024 Date Issued:  January 15, 2024 To further guide the standardized development of real-world research on medical devices, CMDE has formulated this guideline. It serves as a guiding document for registration applicants and technical reviewers. This guideline applies to real-world research on medical devices but is not applicable to real-world research on IVD( in vitro diagnostics）. …

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