In August 2023, the National Medical Products Administration (NMPA) announced adjusting some contents of the “Medical Device Classification Catalog”, which involves 58 medical device classifications.

The important adjustments are as follows:

1.

Refining the description, intended use, name, and category 01-01-03 “Ultrasound Surgical Equipment Accessories” into two categories, one for dissector/ scalpels used in conjunction with the main unit of ultrasound surgical system for soft tissue, which is upgraded to Class III; and the other one for dissector/ scalpels used in conjunction with the main unit of ultrasound surgical system for bone and dental, which remains Class II.

2.

Adding category 01-10-06 “Breast rotary biopsy system and accessories” under the category 01-10 “Other surgical equipment”, which is classified as a Class III device.

Starting from the date of this announcement, new applications should adhere to the aforementioned adjustments. 

Applications that were accepted by NMPA prior to this announcement but still under review will be assessed based on the original category. Upon approval, the certificate's expiration date will be limited to December 31, 2025, and the adjusted category will be noted in the certificate's remarks.
For medical devices that have already obtained approval as class II devices, their certificates will remain valid until December 31, 2025. Applicants must amend the certificate before this deadline. If the certificate's expiration date falls within the transition period, applicants can apply for an extension in accordance with the original category, provided no adverse events have occurred.

You can find comprehensive details of these adjustments in the Annex: "Table of Adjusted Sections in the Medical Device Classification Catalog".

 

 

Reference:

NMPA Announcement on Adjusting Parts of the "Medical Device Classification Catalog"