DATE: JUL 10 2024 / SOURCE: YICAI
(Yicai) July 10 -- Chinese regulators have pushed back the deadline by which manufacturers of radio frequency beauty devices, such as skin tightening machines, need to register as medical products by two years, to give them more time to meet the tough standards or to develop new products.
The deadline has now been extended to April 1, 2026, after which those radio frequency beauty devices that have not obtained a Class III medical certificate, which is the highest level of medical device certification, will not be allowed to be produced, imported or sold, the National Medical Products Administration said on July 8.
Since the new rules were rolled out in March 2022, not a single manufacturer of radio frequency beauty devices has successfully obtained the certification. It normally takes two or more years for a company to complete the registration cycle.
Regulators decreed at the time that in the interests of public safety, the orderly development of the sector as well as the progress of research and development, beauty devices that use radio frequency waves must obtain the highest level of medical device certification by April 1 this year.
The National Medical Products Administration has decided to extend the buffer period, as due to the impact of the Covid-19 pandemic, it is taking companies more time to prepare the application and supplementary materials, it said.
As the new regulations prepare to take effect, many radio frequency beauty instrument makers, most of which are home appliance firms, have been clearing out existing inventory and have gradually stopped selling these products.
Leading manufacturer Amiro, which recently said it is applying for a Class III medical device certification, is rumored to have laid off a lot of workers recently.
The new rules have also affected Japanese beauty instrument giant Ya-Man. Its China sales plunged 37 percent in the 12 months ended April 30 from a year earlier to JPY11.3 billion (USD70 million), dragging down the Tokyo-based company's net profit 90 percent year-on-year to JPY398 million (USD2.4 million), according to its annual report. Revenue plunged 26 percent to JPY32 billion.