Notice on Adjusting the Business Scope of eRPS (2024 No. 7)

Announcement, CMDE / By

The electronic Regulated Product Submission (eRPS) was implemented starting from June 24, 2019. However, NMPA has announced its decision of excluding the registration submission from the eRPS system in order to make it more convenient to the applicants. Meanwhile, NMPA issued the electronics documents structure to help the applicants to prepare the submission dossier.     …

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China CMDE Technical Review 2023 Annual Report

CMDE, Technical Review / By

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 of 30 Articles Published in Technical Review Forum in 2023

CMDE / By

CMDE regularly publishes the opinions of reviewers from various departments regarding cutting-edge information, international supervision, review work, etc. These articles are great help to the industry to get more understanding to the technical review key concerns. Shoot us your questions, we can check for you and interpret the opinions for you.

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

CMDE, Guidelines, Technical Review / By

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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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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Technical Review Report for Registration of Intravascular Shock Wave Therapy Devices 

CMDE / By

China CMDE released the Technical Review Report for Registration of Intravascular Shock Wave Therapy Devices on January 11, 2024. This is a Class III device applied by Lepu (Beijing) Medical Device Co., LTD. The products are used for the pretreatment and balloon dilation of primary coronary artery calcified lesions in adult patients, and the main …

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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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