China beauty device rules: Regulator indicates radiofrequency products will be classed as medical item

China’s National Institute for Food and Drug (NIFDC) recently published a trio of documents soliciting public opinion on the regulation of portable radiofrequency (RF) beauty devices.

RF therapy is a non-surgical procedure that generates heat to stimulate collagen to tighten and firm the skin.

Aside from being a staple on salon menus, brands such as TriPollar, YA-MAN, NEWA and Panasonic have developed portable versions that claim to be safe and effective enough to deliver anti-ageing results at home.

The NIFDC stated that the guidelines were released to standardise the management of all products that use RF.

“The goal is to promote the high-quality development and scientific supervision of radiofrequency beauty products, standardise the review and approval of such products from the source.”​

The NIFDC worked with several departments, including the Medical Device Standards Management Center, to compile the guidelines.

Proper classification

In an effort to properly classify them, the document listed three definitions for RF devices, namely devices that use RF to gently heat the skin, cause pathological or physiological changes in human tissues and cells, or cause ‘obvious change of skin quality’.

The NIFDC noted that it was imperative to establish a clear definition to avoid confusion, especially as more portable RF devices appear on the market.

“At present, radiofrequency technology products are widely used in other fields such as in daily life, in addition to their applications in the medical field. At the same time, there are many types of radiofrequency beauty products with different structures and uses.”​

According to these definitions, portable RF beauty devices would likely fall into the first subcategory.

The NIFDC proposed that all three subdivisions should be defined as medical devices. According to China’s current medical device management, medical devices are subdivided into three categories.

The first category only requires filing, however, the second and third tier of medical devices also require clinical testing and registration with the provincial Medical Products Administration and National Medical Products Administration.

The guidelines suggested that due to the level of risk, RF products should be categorised as a level two or three medical device.

“According to the risk level of RF beauty products, the management category should not be lower than category II.”​

China’s beauty device boom​

According to Daxue Consulting, China is the largest beauty device market in Asia, surpassing $1bn in sales.

It is expected to continue growing as these devices gain more attention thanks to the evolving beauty needs of Chinese consumers.

Last year, Japanese beauty major Shiseido established a joint venture with Japanese beauty device company YA-MAN to develop four products, including a face and eye care device under the new brand EFFECTIM.

The beauty devices utilise Super Treatment Essential Method (STEM) Multi Force, a new technology developed by the company.

One of the aims of EFFECTIM was to target the lucrative China market, which it expected to grow at a CAGR of over 50% during the forecast period of 2017 to 2020.

Shiseido had predicted that the market for beauty devices in China would account for 70% of the market in Asia, especially since it has observed the market growing scientifically amid the COVID-19 pandemic and the rise of at-home treatments.