On April 23rd, China CMDE issued the draft guidance “Guidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)”.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 »
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 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.
On March 18, 2024, CMDE.NMPA issued the “Guideline for Registration Review of Monkeypox Virus Nucleic Acid Detection Reagents” Log in for original documents.
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 …
Release date:2024-01-09 The Guiding Principles for Medical Device Registration Review (hereinafter referred to as the Guiding Principles), as a new tool, method, and standard for medical device technical evaluation, play an important role in improving scientific evaluation capabilities and promoting the high-quality development of the industry. CMDE adheres to the principle of scientificity and constructs a …
China CMDE has issued 613 guidelines for medical device registration review Read More »
