Submission type Product classification Average review time(days) Average time of expert consultation(days) Average time of deficiency response(days) Total time(days) Product registration Class II 72 0 293 365 Class III 99 1 164 265 Class II and III 96 1 180 278 Change of registration Class II 51 0 69 120 Class III 72 0 73 …
CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department May 10, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics General Operation Dept May 17, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics May 24, 2024 Dept 3/4 /5 of Technical Review May 31, 2024 …
As of March 31, 2024，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 9549 4194 817 710 2832 44041 …
Information related to medical device registration licenses in China Read More »
On April 3, 2024, CMDE issued a notice to publicly solicit participating companies in the medical device clinical evaluation industry standard formulation project. Standards to be initiated or modified in 2024： Qualification for the applicants: Companies interested in participating in the compilation work are requested to fill in the “2024 Medical Device Clinical Evaluation Industry …
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 …
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 …
Four Guidelines for Registration Review were released by CMDE.NMPA Read More »
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 …
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 …
Medical Device Registration and Licensing Information in China Province Read More »
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 »
