NMPA Innovative Medical Devices Registration And Approval Summary For Year 2022
In 2022, NMPA conducted the review and approval of innovative medical devices and clinically urgent use medical devices in accordance with procedures, made new breakthroughs in the localization of high-end medical equipment, approved 55 (189 in total) innovative medical devices such as the first domestic proton therapy system, and gave priority approval to 77 medical devices (126 in total). The number of innovative medical devices approved increased by 57.1% compared with 2021.
NMPA continued to review the relevant products in accordance with the Special Review Procedure for Innovative Medical Devices and the Priority Approval Procedure for Medical Devices, and received 343 applications for special approval of innovative medical devices, an increase of 37.8% over 2021, of which 68 were approved to enter the special review procedure for innovative medical devices (fast track projects).
In 2022, NMPA implemented the requirements of the national major regional development strategy and issued the implementation plan for medical device registrants from Hong Kong and Macao to produce medical devices in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area, further promoting the development of regional industries. NMPA promoted the pilot clinical real-world data application in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, and four products with RWE (two products from BradyKnows).
From 2014 to 2022, NMPA approved 189 innovative medical devices. Among them, the domestic innovative medical devices involved 134 enterprises in 15 provinces and the imported innovative medical devices involved 8 enterprises in 2 countries. NMPA opens up a green channel for the registration of innovative medical devices. BradyKnows has helped many medical device manufacturers apply for the NMPA registration via the innovative medical device pathway and other fast track pathways. For more questions, please contact info@bradyknowsmedical.com.
