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.
