2019 Annual Report, Strengthening Scheme and Updates on Medical Device Mandatory Standards

On July 7, the NMPA (National Medical Products Administration) issued a notice addressing 6 action items to strengthen the mandatory standards for medical devices by:

• Requiring all government units to acknowledge the standards’ legal status and significance
• Enhancing the systematic procedure for standard updates
• Enhancing the drafting and implementation procedures for standards
• Training internal units to ensure the standards are successfully implemented and enforced
• Streamlining the execution of technical review and evaluation procedures
• Analyzing the effectiveness of standards to improve the quality

Mandatory standards in China are called GB standards (Guo Biao or national standards) and YY standards (industry standards). The notice explains the importance of the management and administration of mandatory standards, and expects more standards to be implemented in the near future.

On July 8, the NMPA issued a report covering the progress of China’s “five-year plan” and included a breakdown of the total existing and new standards for medical devices in 2019. According to the report, China has implemented a total of 1671 mandatory standards for medical devices, while 1451 of them are YY standards, 220 are GB standards.

Top 5 Product Scopes with the Most Standards

• Medical electrical products and equipment: 339 standards (20.3%)
• IVDs: 243 standards (14.5%)
• Surgical implants: 209 standards (12.5%)
• Dentistry products: 163 standards (9.8%)
• Infusion products and equipment: 148 standards (9.8%)

By the end of 2019, 447 standards have been revised by the NMPA achieving 89% of the “five-year plan” target (500 standards). Currently, China is a member of the IMDRF (International Medical Device Regulation Forum), and contributed to transfrom 582 (90%) of the 670 ISO and IEC standards into Chinese standards. As a result, the China requirements are becoming clearer for overseas importing medical device product.

On June 30, the NMPA announced a list of new and amended YY standards:

• 41 newly added YY standards
• 2 amended YY standards (First Link and Second Link)

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