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.