- (1) Starting from April 1, products of radio frequency (RF) therapeutic apparatus and skin therapeutic apparatus, such as portable RF, which belong to the category no. 09-07-02 radio frequency therapy (non-ablation) equipment, the application for product registration shall be made in accordance with the provisions of the measures for the registration and filing of Medical Devices (Order No. 47). Consequently, starting from April 1, the production, import and sale of radio frequency therapeutic apparatus and skin therapeutic apparatus products without an obtained medical device registration certificate in accordance with the law shall not be allowed.
- (2) Please further note that a total of 10 kinds of medical devices, such as 02-15-14 clamp devices, were adjusted in the classification catalogue of Medical Devices.
- (3) Lastly, products related to “14-10-08 liquid dressing”, are adjusted from Class I to Class II. Related products are provided with non-sterile materials and act as a physical barrier by forming a protective layer on the wound surface. Liquid dressings used for the care of superficial wounds, such as small wounds, abrasions and cuts, shall, from the date of this announcement, apply for registration in accordance with the provisions of the measures for the registration and filing of medical devices (Order No. 47). For those who have already filed as a class I medical devices before January 1 2022 according to the 2017 edition of the medical device classification catalogue, the registration shall remain valid until April 1 2023. However, from April 1 2023 onwards, such products may no longer be produced, imported or sold without a medical device registration certificate according to the new classification.
Announcement of NMPA on Adjusting Part of the "Medical Device Classification Catalog" (No. 30 of 2022)
Announcement of NMPA on Adjusting Part of the "Medical Device Classification Catalog" (No. 25 of 2022)