On April 23rd, China CMDE issued the draft guidance “Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)”. CMDE called for public comments on the draft guidelines before May 6th.
On April 11, 2024, CMDE released the 2024 medical device registration review guideline preparation plan. Please refer to the following list: Plan for the formulation of guidelines for registration review of Class III medical devices No. Guiding principle name 1 Guidelines for Magnetic Resonance Safety Evaluation of Medical Devices 2 Guidelines for Registration Review of …
China CMDE Medical Device Registration Review Guidelines Preparation Plan in 2024 Read More »
Recently, China CMDE adjusts the digital certificate management method as follows: Starting from April 15, 2024, the management of CA certificates and other matters will be transferred to the CA certificate issuing agency (Beijing Digital Certification Co., Ltd.). CA certificate applications, information changes, renewals, renewals and re-issuances, etc., shall be handled by the medical device …
On April 11st, 2024, China CMDE. NMPA issued “Guidelines for Registration Review of Acellular Matrix Soft Tissue Wound Repair Materials Products (Draft)”. CMDE called for public comments on the guidelines before May 10th.
On April 10,2024, China CMDE.NMPA released Guidelines for Substantial Equivalence Review —clinical evaluation of absorbable surgical sutures (2024 No.15). Contact us for original documents.
On March 25, 2024, China CMDE has compiled three medical device registration review guidelines: ” Guidelines for Registration Review –Antibacterial Performance Evaluation of Orthopedic Implants”, ” Guidelines for Registration Review –Type I Collagen Cartilage Repair Products”, and ” Guidelines for Registration Review –Oral Repair Membranes”. CMDE called for public comments on these guidelines before April …
China CMDE call for public comments on 3 Draf Guidelines Read More »
On March 26th, 2024, China CMDE.NMPA released “Guidelines for Registration Review of High-Frequency Surgical Equipment “(2023 Revised Edition). Contact us for the original document.
CMDE is starting the preparation of the ” Guidelines for Registration Review of Metal Bone Marrow Aspiration Needle”, ” Guidelines for Registration Review of Memory Alloy Rib Plating System”, ” Guidelines for Registration Review of Mesh for Skull Repairing”, ” Guidelines for Registration Review of Sternal Strapping/Grasping Fixation System”, “Guidelines for the Registration Review of …
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 »
On March 19, 2024, CMDE.NMPA released “Guidelines for Registration Review of Medical Device Usability Engineering”. Log in for original document.
