NMPA 2020 Annual Report on Medical Device Mandatory Standards

On February 5, 2021, the NMPA (National Medical Products Administration) issued a report covering a breakdown of the total existing and new standards for medical devices in 2020. According to the report, China has implemented a total of 1,758 mandatory standards for medical devices: that’s 1,532 YY standards, and 226 GB standards.

Top 5 Product Scopes with the Most Standards

• Medical laboratory equipment: 242 standards (14%)
• General and microsurgical instruments: 202 standards (11%)
• Orthopedics and surgical instruments: 198 standards (11%)
• Dentistry products: 169 standards (10%)
• Medical X-ray equipment: 138 standards (9%)

By the end of 2020, a total of 561 standards have been revised by the NMPA exceeding the “five-year plan” target (500 standards) by 12%.

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