On April 12, 2023, China’s Medical Device Technology Review Center of the State Food and Drug Administration issued the “Guiding Principles for Registration Review of Radiofrequency Beauty Equipment (No. 8, 2023)”. Industry insiders said that this is to prepare for "on April 1, 2024 next year, radio frequency beauty instruments will be officially included in the management of third-class medical devices."

Starting from April 1, 2024, radiofrequency therapy devices and radiofrequency skin therapy products may not be produced, imported, or sold without obtaining a medical device registration certificate in accordance with the law. Moreover, according to the "Guiding Principles for Registration Review of Radiofrequency Beauty Equipment (No. 8, 2023)", radiofrequency beauty devices managed according to the three categories of medical devices still need to conduct clinical trials before obtaining a registration certificate, which means that radiofrequency beauty devices are allowed to enter the market. The threshold has been raised significantly. Industry insiders generally believe that beauty devices will enter a real reshuffle and the bonus period is over!

After the implementation of the new regulations, beauty device companies will not only have to invest more in research and development, experiments, clinical evaluation and production, but the existing sales and promotion system will also undergo earth-shaking changes. Clinical certification takes a long time, even in years. As a result, a large number of unqualified Internet brands will be eliminated.

At present, most radio frequency beauty devices are promoted through celebrity endorsements, live broadcasts, KOL/KOC, etc. However, according to regulations, whether it is an operating enterprise, agent or distributor, anyone involved in the circulation of third-class medical devices, Must hold a Class III medical device business license.

Moreover, the Advertising Law stipulates that medical device products cannot use advertising spokespersons to make recommendations. Even if they are to be advertised, they must be reviewed by relevant departments. In other words, after the new regulations are implemented, beauty devices cannot be promoted through the above methods.

What are Class III medical devices?

Class I medical devices refer to medical devices whose safety and effectiveness can be guaranteed through routine management. Generally, the Municipal Food and Drug Administration will review and approve and issue a registration certificate. Its operations do not require a "Medical Device Business License" and only need to register with the Industry and Commerce Bureau. For example: external hemostatic patch. It should be noted that not all "hemostatic patches" are Class I. Some are Class II medical devices, and some are chemical drugs. These are determined based on the nature of the product itself.

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Generally, the provincial Food and Drug Administration will review and approve and issue a registration certificate. For example: thermometer, blood pressure monitor, condoms (condoms), etc. The state has successively released two batches of second-class medical devices that do not need to apply for a "Medical Device Business Enterprise License". The first batch contains 13 products. Its products are: thermometers, sphygmomanometers, medical absorbent cotton, medical absorbent gauze, and medical hygiene products. Masks, magnetic therapy equipment, household blood glucose meters, blood glucose test strips, pregnancy diagnostic test strips (early pregnancy test side test strips), condoms, contraceptive caps, wheelchairs, and medical sterile gauze. There are six products in the second batch that do not need to apply for a "Medical Device Business License": electronic blood pressure pulse meters, plum blossom needles, three-edged needles, acupuncture needles, ovulation detection test strips, and portable oxygen generators.

Class III medical devices refer to medical devices that are implanted in the human body; used to support and maintain life; and are potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled. Generally, the State Food and Drug Administration will review and approve and issue a registration certificate.

UE Power cooperates with many domestic and foreign beauty instrument manufacturers to provide medical-grade power adapters and professional EMC laboratories to help customers complete product transformation and upgrades.