China Gives Radio Frequency Beauty Device Makers More Time to Meet Higher Standards

(Yicai) July 10 — Chinese regulators have pushed back by two years the deadline for makers of radio-frequency beauty devices such as skin-tightening devices to register as high-end medical devices, giving them more time to meet stringent standards or develop new products.

That deadline has been extended to April 1, 2026. After that date, radio frequency cosmetic devices that have not obtained Class III medical certification, the highest level of certification for medical devices, will not be allowed to be manufactured, imported or sold, the National Medical Products Administration said July 8.

No manufacturer of radiofrequency cosmetic devices has successfully achieved certification since the new regulations were introduced in March 2022. It typically takes a company two or more years to complete the registration cycle.

Regulators then decided that, in the interests of public safety, the proper development of the sector, and the progress of research and development, cosmetic devices using radio waves must achieve the highest level of medical device certification by April 1 this year.

The National Agency for Medical Products has decided to extend the buffer period because due to the impact of the Covid-19 pandemic, companies need more time to prepare the application and supporting materials, it said.

As the new regulations come into effect, many manufacturers of radio frequency beauty devices, most of which are home appliance companies, have begun selling off their stocks and phasing out sales of the products.

Rumor has it that leading manufacturer Amiro, which recently announced it was seeking Class III medical device certification, has recently laid off a number of employees.

The new rules also hit Japanese beauty-device giant Ya-Man. Its sales in China fell 37 percent in the 12 months to April 30 from a year earlier to 11.3 billion yen ($70 million), cutting the Tokyo-based company’s net profit 90 percent year-on-year to 398 million yen ($2.4 million), according to its annual report. Revenue fell 26 percent to 32 billion yen.

Editors: Dou Shicong, Kim Taylor