NMPA Encourages High-quality Development Of Medical Device Industry

In 2021, NMPA continues to encourage high-quality development of medical device industry through innovation pathway, priority pathway, real world data pilot pathway, AI and combo support.

Innovation pathway

In 2021, NMPA approved 35 innovative medical devices such as coronary blood flow reserve fraction calculation software. By the end of 2021, 134 innovative medical devices have been approved to meet the needs of the patients to use high-level medical devices.

Priority pathway

According to the approval procedure of priority medical devices, 19 medical devices such as genetic deafness gene detection kit were approved. By the end of 2021, 49 priority medical devices were approved, so as to better meet the needs of clinical use.

AI support

NMPA established a biomaterial innovation cooperation platform, cooperating with MIIT to launch the task of artificial intelligence medical device innovation, creating a master document registration system, accelerating the approval of new materials, new technologies and new products, and helping the high-quality innovation and development of the industry.

Real world data pilot pathway

NMPA continues to support the construction of key areas such as Hainan Boao Lecheng International Medical Tourism Pilot Area and Guangdong-HongKong-Macao Great Bay Area, guiding the import of a small amount of medical devices urgently needed in clinic use, steadily promoting the pilot application of clinical real-world data, and approved the second product (“femtosecond laser ophthalmic treatment system”) using clinical real-world data.

Combo support

NMPA also optimized the approval certification requirements of drug-device combination products, issued the notice on matters related to the registration of drug-device combination products (No. 52, 2021), and speed up the approval of drug-device combination products with clinical value. BradyKnows has extensive experiences in innovation pathway, priority pathway, Hainan real world data pathway, AI and combo registration. Please feel free to reach out to info@bradyknowsmedical.com for any questions in China.