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 …
On June 7, China NMPA held a meeting to review and approve the “Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)”. It will come into effect on October 1, 2024.
China NMPA canceled a total of 4 medical device registration certificates of the following 3 companies based on their applications. (1)Brain aneurysm clip, Registration Certificate Number: 国械注准20163131005. (2)Titanium mesh screw system for skull repair, Registration Certificate Number: 国械注准20173130706. (1) Zirconia ceramic blocks for all-ceramic dentures, Registration Certificate Number:国械注进20222170163. (1) Spinal Fixation System, Registration Certificate Number: …
4 Medical Device Registration Certificates Were Cancelled by China NMPA 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 »
The following is the summary of medical device technical review in April 2024: Submissions Overview In Process of Technical Review:1500 Technical Review Completed:1439 Submissions Accepted Document Review:1629 Submissions Accepted:2401 Filing Modification :939 Import Class I Device Filing:262 RFEs and Responses to RFEs RFE released: 659 RFE Response Accepted: 561 Advisory Meetings Meeting initiated: 14 Meeting …
Summary of medical device technical review in April 2024 Read More »
In April 2024, China NMPA approved 292 medical devices, including 37 Class III imported products, 30 Class II imported products, and 224 Class III domestic products. China NMPA is constantly upgrading regulations and guidelines for medical device regulatory, clinical affairs and post market surveillance in latest years. GVM Medical LLC has extensive experience to support …
China CMDE recently issued an interpretation of the guidelines for Registration Review of Medical Device Usability Engineering. In this document, China CMDE interpreted the background of the guideline. It is also to follow the medical device regulators in US and CE. Class II/III registration shall follow the guideline, but IVD is excluded. The key points …
According to Announcement No. 30-2022, RF therapy and RF skin therapy devices (Product code #09-07-02) shall be regulated as Class III medical devices. Announcement No. 30-2022 mainly provided new requirements of the classification and regulation of RF devices intended to be used in the aesthetic field. The following aspects represent the current thinking of NMPA. …
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 …
CMDE is starting the preparation of the “Guideline for Registration Review of Human KRAS Mutation Gene Detection Reagents (PCR Method)”, “Guideline for Registration Review of Glucose-6-Phosphate Dehydrogenase Detection Reagents” and “Guideline for Registration Review of Enzyme Detection Reagents Traceability” . Companies participating in the preparation work are now being solicited, and domestic and foreign production …
