China CMDE call for public comments on 3 Draf Guidelines

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 »

Preparation and Revisions for 6 Guidelines.

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 …

Preparation and Revisions for 6 Guidelines. Read More »

What Are the Required Validation and Verification for Sterile Medical Devices Production?

Sterile medical devices, which have direct or indirect contact with the human blood system or human tissue, play a critical role in the patients’ safety.  More stringent requirements regarding the production process control and quality control are required by China GMP. The following are some examples of validation and verification items, which may help you …

What Are the Required Validation and Verification for Sterile Medical Devices Production? Read More »

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”.

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 …

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”. Read More »

Four Guidelines for Registration Review were released by CMDE.NMPA

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 »