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.
