1. New Requirements for RF Therapeutic Apparatus
Starting from April 1, products of radio frequency (RF) therapeutic apparatus and skin therapeutic apparatus, such as portable RF, which fall under category no. 09-07-02 (radio frequency therapy, non-ablation equipment), are required to register their products according to the guidelines set forth in Order No. 47 for the registration and filing of Medical Devices. Consequently, beginning April 1, the production, import, and sale of these radio frequency therapeutic products without a valid medical device registration certificate will not be permitted.
2. Adjustments to Medical Device Classification
It is important to note that a total of 10 kinds of medical devices, including clamp devices classified under 02-15-14, have undergone adjustments in the medical device classification catalog.
3. Changes for Liquid Dressing Products
Products related to "14-10-08 liquid dressing" are now classified from Class I to Class II. These products, which provide non-sterile materials acting as a physical barrier on the wound surface, will require registration according to the measures for registration and filing of medical devices (Order No. 47). Liquid dressings intended for caring for superficial wounds (e.g., small wounds, abrasions, cuts) must comply with these new requirements immediately following this announcement. Those who previously filed these products as Class I medical devices before January 1, 2022, under the 2017 edition of the medical device classification catalog, will have their registrations maintained until April 1, 2023. However, from that date onward, these products must have a medical device registration certificate based on the new classification for production, import, or sale.
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Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |