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 …
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 …
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 …
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).
Remark： 1.The time in this table is working days. 2.Average time of deficiency response = total time of deficiency response /total number of completed and transferred submissions with deficiencies. 3.Total time = average review time+ average time of expert consultation + average time of deficiency response. 4.Average time for Class II and III products = …
CMDE is soliciting participation in the revision and preparation of the “Guidance for Registration Review of Platelet-rich Plasma Preparation Device” and the “Guidance on Conditional Approval of Medical Devices (2024 Revised Edition)”. It invites domestic and foreign manufacturers, research institutions, and clinical institutions with relevant experience to actively participate. Interested parties are invited to fill …
Two guidelines are solicited for participating units Read More »
CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department July 5, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics (Video) July 12, 2024 Dept 3/4 of Technical Review Dept 5 of Technical Review (Video) July 19, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics …
China CMDE is starting the preparation of the “Guidelines for Registration Review of Carbon Dioxide Laser Therapy Devices”. Companies participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with relevant work experience are invited to actively participate. Companies interested in participating in the …
Guidelines for Registration Review of Carbon Dioxide Laser Therapy Devices Read More »
NMPA has launched the e-Notice system regarding medical device registration decision starting from June 1, 2024, according to Announcement #68, 2024. The documents include Reject to Registration, Termination of Submission Review, Reject to IFU Modification, etc. Applicants can search the submission review status of in the NMPA Portal. The above e-Notice has the same legal …
Announcement of e-Notice of Medical Device Registration Read More »
