In February 2023, NMPA approved 162 medical devices, including 19 Class III imported products, 22 Class II imported products, and 120 Class III domestic products.
Below is a list of approved Class III and Class II imported products in February 2023.
Medical Device/IVD
Manufacturer
Category
OR3O Dual Mobility System
Smith & Nephew, Inc.
Class III
AOSept Plus with HydraGlyde lens case solution
Alcon Laboratories, Inc.
Class III
V-Loc 180 Absorbable Wound Closure Device
Covidien llc
Class III
HOYA iSert Preloaded Intraocular Lens
HOYA Medical Singapore Pte. Ltd.
Class III
Aspiration catheter
Genoss Co., Ltd.
Class III
Dextile™ Anatomical Mesh
Sofradim Production
Class III
Railway Sheathless Access System
Cordis Corporation
Class III
Endoscopic Linear Cutter Reload Kits with Gripping Surface Technology
Starting from 2020, impacted by the COVID-19, the China NMPA extended the supplemental phase for the medical device registration over one year.
In a recent notice from the NMPA, with the release of the COVID-19 prevention measures in China, the NMPA has changed the requirements for the supplemental phase as follows:
For registration submission that received the supplemental notice before February 20, 2023, the supplementary phase will still be extended to 2 years.
For registration submission that receives the supplemental notice after February 20, 2023 (including February 20), the supplemental phase will be reverted back to 1 year.
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).
