CMDE release 4 guidance for medical device product registration review
On February 5, 2024, China CMDE released 4 guidance documents for ME Equipment submission and review as the following: Login for more information.
Notice on Adjusting the Business Scope of eRPS (2024 No. 7)
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. …
Notice on Adjusting the Business Scope of eRPS (2024 No. 7) Read More »
Total 71 Frequently Asked Questions in 2023 Were Issued by CMDE
Here are 10 of 71 frequently asked questions: If you have any specific questions, we can help you to check the list and interpretate the answers from the CMDE.
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 …
Total 106 public review reports published by CMDE in 2023
CMDE publish a total of 106 product technical reviews reports in 2023. The following is the list of the reports:
Total of 30 Articles Published in Technical Review Forum in 2023
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
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 …
Total 67 Guidance Documents Were Issued by CMDE in the year 2023 Read More »
The Accredited laboratories List for GB 9706.1-2020 and YY 9706.102-2021
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 …
The Accredited laboratories List for GB 9706.1-2020 and YY 9706.102-2021 Read More »
Technical Review Report for Registration of Intravascular Shock Wave Therapy Devices
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 …
Technical Review Report for Registration of Intravascular Shock Wave Therapy Devices Read More »
Gold Marker Kit Gets Priority Approval
China CMDE reviewed Gold Marker Kit for soft tissue on January 22, 2024. It gets priority approval because of its innovation advantage. This is a device urgently needed in clinical practice while there is not any similar approved medical device in China. This device registration applicant is Naslund Medical AB. Should you have any questions, …