1 April 2026 is an important regulatory point for RF beauty-device companies. China’s 2024 Announcement No. 84 states that relevant RF treatment and RF skin-treatment products within the adjusted catalogue may not be manufactured, imported or sold without required medical-device registration from that date.
1. Which products are targeted
The announcement connects with the catalogue adjustment for non-ablative RF treatment equipment. Official explanations focus on products acting on skin and subcutaneous tissue and causing pathological or physiological changes to achieve an intended purpose.
2. Does every RF product require registration?
No single conclusion follows merely from the presence of an RF module. Energy, structure, body area, temperature rise and intended purpose may differ. However, “daily care,” “home use” or “beauty salon use” are not automatic exclusions. The company must show what the real product does.
3. Companies with an existing non-medical result
- Confirm the result and current model are identical.
- Check frequency, power, levels and handpieces.
- Review software changes that alter output.
- Review instructions, livestreams and training for treatment claims.
- Check distributor wording.
4. Companies without a clear route
Freeze the sample and parameters, verify output and temperature, document actual effects and business purpose, and compare the feasibility, cost and commercial value of medical registration with a genuine non-medical redesign.
5. Main risks
Avoid selling an unregistered product that meets the medical-device definition, filing a low-output version while selling a high-output version, relying on another company’s result, or changing only the product name.
RF routing is product-specific and should be assessed against the announcement, catalogue and verified technical facts.