NMPA Updated Medical Device Classification Catalog (No. 101 Of 2023)

In accordance with the relevant requirements of the Regulations for the Supervision and Administration of Medical Devices (Order 739) and the Procedures for Dynamic Adjustment of the Medical Device Classification Catalog, NMPA is adjusting Medical Device Classification Catalog periodically.

On Aug 17, NMPA announced the adjustment of the classification content about 58 types of medical devices. For example, some devices as “ultrasound surgical equipment accessories” under Classification Code 01-01-03 on the Catalog were adjusted from the original Class II to Class III, e.g., ultrasound cutting and hemostatic electrode, ultrasound soft tissue surgical electrode, ultrasound suction surgical electrode.

If the registration of such devices with category adjustment has been accepted during the review process, NMPA will continue to review your project, and approve if meeting the requirements, but the certificate will be granted with the expiry date of Dec 31, 2025.

For the products with certificate as Class II, the certificate is still valid by Dec 31, 2025, and meanwhile, the manufacturer should conduct and complete the certificate modification on category information adjustment.  

BradyKnows elite team has extensive regulatory and quality experiences in China. If you need identify how to handle your registration in China, please contact info@bradyknowsmedical.com.