CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department November 1, 2024 Dept 3/4 of Technical Review Dept 5 of Technical Review (On-Site) November 08, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics General Operation Dept (On-Site) November 15, 2024 Dept 1/2 of Technical Review Dept 1 of …
As of August 31st, the medical device licensing and filing 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 9640 4801 768 715 2868 44657 …
Information related to medical device registration licenses in China（As of August 31） Read More »
On August 28, 2024, China NMPA issued the Medical Device Administration Law of the People’s Republic of China (Draft) for public comment. NMPA called for public comment before September 28, 2024.
CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department September 6, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics (On-Site) September 13, 2024 Dept 3/4 of Technical Review Dept 5 of Technical Review (On-Site) September 20, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics …
No. Product Name Name of the filing person Production address Filing date Status 1 Screwdriver Neobiotech Co., Ltd. 104, 24/102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 10F, 36, Digital-ro 27-gil, Guro-gu, Seoul, KOREA 2024-07-31 Change 2 Sinus Lift Kit Neobiotech Co., Ltd. 104, 24/102, 103, 104-1, 104-2, 105, 106, 205, …
NMPA registration information for imported Class I medical devices in July 2024 Read More »
As of July 31st, the medical device licensing and filing 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 9589 4701 771 716 2872 45088 …
Information related to medical device registration licenses in China（As of July 31） Read More »
On August 12, 2024, the CMDE issued 12 guidelines. The list is as follows: 1. Guidelines for registration review of hydrogel dressings 2. Guidelines for registration review of dialysate filters 3. Guidelines for registration review of single-use side hole blunt needle technology 4. Guidelines for registration review of disposable intravenous indwelling needle 5. Guiding principles …
On August 9, the national centralized unit of standardized technology for clinical evaluation of medical devices issued 2 industry standard drafts “Medical device real-world data terms and definitions” and “IVD reagents clinical trial biological sample management requirements “ and called for public comments on the draft standards before October 8. For more infomation, please contact …
The following is the summary of China CMDE medical device technical review in June 2024: Submissions Overview In Process of Technical Review:1066 Technical Review Completed:964 Submissions Accepted Document Review:1010 Submissions Accepted:1817 Filing Modification :892 Import Class I Device Filing:160 RFEs and Responses to RFEs RFE released: 381 RFE Response Accepted: 411 Advisory Meetings Meeting initiated: …
Summary of medical device technical review in June 2024 Read More »
It is recommended to refer to the requirements of GB/T 16886.1 standard, including at least cytotoxicity, sensitization, irritation or intradermal reaction, material mediated thermogenicity, acute systemic toxicity, subacute toxicity, subchronic toxicity, chronic toxicity, implantation reaction, blood compatibility, genotoxicity, carcinogenicity (if applicable).
