NMPA: The Classification Catalogue of Medical Devices has been greatly adjusted!

On October 31, the NMPA issued the Notice on Seeking Adjustment Opinions on the Classified Catalogue of Medical Devices (hereinafter referred to as the “Notice”), asking for adjustment opinions on the 57 categories of medical devices related to the Classified Catalogue of Medical Devices.

The notice said that according to the Working Procedure for Dynamic Adjustment of the Classification Catalog of Medical Devices and relevant requirements, the Medical Device Standard Management Center of the NMPA, on the basis of collecting the adjustment opinions of the Classification Catalog of Medical Devices in the early stage, organized the professional group of the Medical Device Classification Technical Committee to study and form the dynamic adjustment opinions of the Classification Catalog of Medical Devices, and now solicits opinions from the public.

A total of 18 categories of medical instruments have been adjusted this time, including active surgical instruments, passive surgical instruments, neural and cardiovascular surgical instruments, orthopedic surgical instruments, medical imaging instruments, medical diagnosis and monitoring, 9 physical therapy instruments, blood transfusion, dialysis and extracorporeal circulation instruments, passive implantation instruments, injection, nursing and protection instruments, ophthalmic instruments, stomatological instruments, gynecology and obstetrics, assisted reproductive and contraceptive instruments, medical software， clinical laboratory instruments. Among them, the adjustment of passive implant device is the most, with 15 items in total.

At the same time, some product supervision categories have changed. For example, ultrasonic hemostatic scalpel, breast rotary cutting biopsy system and accessories, intracranial thrombus removal stent, intracranial thrombus removal device, mechanical perfusion and transportation equipment for isolated organs, left atrial appendage clamping system, artificial cornea and other medical devices will be supervised in accordance with the standards of Class III medical devices in the future.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

By Alliance of Medical Device Distributors

Translated & edited  | Bradyknows