China Regulatory Round-up for Medical Devices in March 2021

On March 17, 2021, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) issued regulatory guidelines (draft) for 22 medical devices:

• Technical Guidelines for the Registration of Minimally Invasive Fascial Closure Devices for Disposable Use (Draft)

• Technical Guidelines for the Registration of Disposable Ureteral Introducer Sheaths (Draft)

• Technical Review Guidelines for Registration of Low Temperature Gas Sterilizers (Draft)

• Guiding Principles for Technical Review of Registration of Arthroscopic Passive Surgical Instrument Products (Draft)

• Technical Guidelines for Product Registration of Prothrombin Time Activated Partial Thromboplastin Time Prothrombin Time Fibrinogen Assay Reagents (Draf)

• Technical Guidelines for Registration of Circumcision Anastomosis Products (Draft)

• Technical Guidelines for Registration Review of Folic Acid Determination Reagents (Draft)

• Guidelines for the Registration Technical Review of X-ray Imaging Equipment Containing Pediatric Applications (Draft)

• Guidelines for the Registration Technical Review of Reagents for the Determination of Anti-Müllerian Tubulin (Draft)

• Technical Guidelines for Registration of Neonatal Blue Light Therapy Instrument Products (Draft)

• Guiding Principles for the Technical Review of Registration of Root Canal Preparation Machines (Draft)

• Guiding Principles for Technical Review of Registration of Orthodontic Wires (Draft)

• Guiding Principles for the Technical Review of the Registration of Gait Training Equipment Products (Draft)

• Guiding Principles for the Technical Review of the Registration of Dental Desensitizer Products (Draft)

• Technical Guidelines for Registration of Mesh Nebulizers (Draft)

• Technical Review Guidelines for the Registration of Pepsinogen III Assay Reagents (Draft)

• Guiding Principles for the Registration Technical Review of Fluorescence Immunochromatography Analyzers (Draft)

• Guiding Principles for the Registration Technical Review of Blood Cell Analyzers (Draft)

• Guidelines for the Registration and Technical Review of Retinol Binding Protein Assay Kits (Immunoturbidimetric Method) (Draft)

• Guidelines for the Registration Technical Review of Ultrasonic Transcranial Doppler Flow Analyzer (Draft)

• Guiding Principles for the Technical Review of Registration of Non-vascular Vascular Guidewire Products (Draft)

• Technical Guidelines for Registration of Anesthesia Mask Products (Draft)

On March 3, 2021, the CMDE also announced their plans to formulate the technical guidelines for products monitoring non-invasive blood / glucose, and solicits input from the medical device industry.

By Jacky Li. Contact Cisema if you would like to learn more.