2021 China Medical Device Standards Catalogue Released

On May 26, 2021, the NMPA (National Medical Products Administration) announced the project to implement and revise a total of 77 medical device industry standards in 2021.

On June 4, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA released a catalogue covering a total of 1,791 medical industry standards that are currently in effect.

The first chapter of the catalogue consists of the following sections:

1. QMS (Quality Management System)
2. UDI (Unique Device Identification)
3. Packaging of Medical Device
4. Biological Evaluation of Medical Device
5. General Requirements of Medical Electrical Equipment
6. General Technology for Disinfection and Sterilization

The second chapter of the catalogue consists of 32 sections including:

• Surgical Instruments
• Medical Biological Protection
• Medical X-ray Equipment and Appliances
• Medical Laboratories and In Vitro Diagnostic Instruments and Reagents

The catalogue lists out the national standards first before listing the industry standards for each section whilst the standards follow the order of their standard number.

National standards in China are called GB standards (Guo Biao) and industry standards are called YY standards. As of May 2021, there is a total of 1,564 YY standards and 227 GB standards.

By Jacky Li. Contact Cisema if you want to learn more.