In March 2024, NMPA approved 325 medical devices, including 29 Class III imported products, 30 Class II imported products, and 265 Class III domestic products.
Below is a list of approved Class III and Class II imported products in March 2024.
Medical Device/IVD
Manufacturer
Category
Hemodialysis Treatment Equipment
Baxter Healthcare SA
Class III
Princess VOLUME Lidocaine
CROMA-PHARMA GmbH
Class III
Introcan Safety 2 Closed IV Catheter
B. Braun Melsungen AG
Class III
Arthrex Fracture Plates and Screws
Arthrex, Inc.
Class III
Sonopet iQ Ultrasonic Aspirator System
Stryker Instruments
Class III
Diode laser system
Lumenis Ltd.
Class III
Sonopet iQ Ultrasonic Aspirator System Accessories
In order to further guide applicants in determining the specific clinical evaluation paths for their registration, the Medical Device Review Center has issued a notice for the release of clinical evaluation recommended paths for a new batch of specific products. This is based on the 2022 notices, “Notice on the Release of Clinical Evaluation Recommended Paths for Products Related to Subcategories 11, 12, 13, 14, 15, 17, and 22 of the Medical Device Classification Catalog (2022 Notice No. 20)”, “Notice on the Release of Clinical Evaluation Recommended Paths for Products Related to Subcategories 02, 03, 05, 06, 16, 18, and 20 of the Medical Device Classification Catalog (2022 Notice No. 24)”, and “Notice on the Release of Clinical Evaluation Recommended Paths for Products Related to Subcategories 01, 04, 07, 08, 09, 10, 19, and 21 of the Medical Device Classification Catalog (2022 Notice No. 30)”.
In June 2021, the new Regulations on the Supervision and Administration of Medical Devices officially came into effect, marking the full implementation of the medical device registrant system. In July 2023, an experience exchange meeting on implementing manufacturing quality management standards under the medical device registrant system was held. It emphasized the need for provincial drug regulatory departments to strengthen quality supervision throughout the entire lifecycle of medical devices and further implement local regulatory responsibilities. Attention was also drawn to different types of registrants, such as those engaging in cross-regional contract, multi-point contract, and self-manufacturing to contract manufacturing, with targeted regulatory measures to mitigate risks.
NMPA medical device classification results in 2024
On April 9, 2024, the National Medical Products Administration’s Medical Device Standard Management Center issued the “Summary of the First Medical Device Classification Results for 2024.” It has been reported that this summary includes a total of 223 medical device product classifications, with 13 related to the field of medical aesthetics. Among these, there are 4 products recommended to be managed as Class III medical devices, 5 products recommended to be managed as Class II medical devices, 1 product recommended not to be managed as a medical device, 2 products recommended to be defined through the procedure for determining the management attributes of drug-device combination products, and 1 product recommended to be determined based on specific circumstances.
