China Regulatory Round-up for Medical Devices in November and December 2020

China Regulatory Guidelines Issued / Updated

1 GB (Guobiao) mandatory standard for transfusion sets will be implemented on June 1, 2022, whilst 2 GB mandatory standards for medical electrical equipment will be implemented on May 1, 2023.

The NMPA issued regulatory guidelines (including drafts) for 16 medical devices throughout November and December 2020:

Technical review guidelines for household in-vitro diagnostic devices
Technical review guidelines for specific protein immunoassay devices
Technical review guidelines for prolactin detection reagents
Technical review guidelines for total triiodothyronine detection reagents
Technical review guidelines for 25 hyrdroxyvitamin D detection reagents
Technical review guidelines for serum amyloid A detection reagents
Technical review guidelines for rheumatoid factor detection reagents
Technical review guidelines for nomenclature of orthopaedic surgical instruments
Technical review guidelines for nomenclature of blood transfusion, dialysis and cardiopulmonary bypass devices
Technical review guidelines for nomenclature of passive surgical instruments
Technical review guidelines for nomenclature of passive implantable devices
Technical review guidelines for nomenclature of disinfection and sterilization devices
Technical review guidelines for electronic upper gastrointestinal endoscope
Technical review guidelines for fundus camera
Technical review guidelines (draft) for biodegradable magnesium orthopaedic implants
Technical review guidelines (draft) for the use of in-vitro diagnostic reagents overseas clinical trial data

China Fast-Track Approval Updates

Amongst the applicants of the 5 medical devices pending for registration approval via the Special Review Procedure for Innovative Medical Devices, the application of the intraocular lens was submitted by Alcon Laboratories, Incorporated, an American-Swiss medical company specializing in eye care products.

The Hepatitis B virus PCR fluorescence quantitative detection kit is pending for registration approval via the Procedure for Prioritized Review, and considered as a major project in China’s national science and technology field. The applicant is a local manufacturer in Suzhou, China.

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