Starting from April 1, 2024, radiofrequency therapy devicesRadiofrequency skin therapy deviceClass products not obtained in accordance with the lawMedical Device RegistrationThe certificate prohibits production, import, and sale. Moreover, according to the Guiding Principles for Registration and Review of Radiofrequency Beauty Devices (No. 8 of 2023), radiofrequency beauty devices managed under Class III medical device management still need to undergo registration before obtaining a registration certificateclinical trialThis means that the entry threshold for radiofrequency beauty devices has significantly increased.

The home beauty device market is experiencing a major reshuffle

After the implementation of the new regulations, beauty device companies will not only need to invest more funds in research and development, experimentation, clinical evaluation, and production, but their existing sales and promotion systems will also undergo earth shaking changes. Clinical certification requires a long time, and it is not an exaggeration to calculate it in years. As a result, a large number of unqualified Internet brands will be eliminated.

At present, most radiofrequency beauty devices are used throughcelebrity endorsementPromote through live streaming sales, KOL/KOC seeding, and other methods, but according to regulations, whether it is operating enterprises, agents, ordealerAny circulation involving Class III medical devices must hold Class IIIBusiness license of medical devices.

And also《Advertising Law》According to regulations, medical device products cannot be recommended by advertising spokespersons, and even if advertisements are to be published, they must be reviewed by relevant departments. Simply put, after the implementation of the new regulations, beauty devices cannot be promoted through the above-mentioned methods.

What are three types of medical devices?

              A type of medical deviceIt refers to medical devices that can ensure their safety and effectiveness through routine management. Generally, the registration certificate is approved and issued by the Municipal Food and Drug Administration. Its operation does not require a Medical Device Business License, it only needs to register with the Industry and Commerce Bureau. For example: external useadhesive bandageIt should be noted that not all "hemostatic patches" are of the same category. Some are second-class medical devices and some are chemical drugs, which depend on the properties of their products.
              Class II medical devicesIt refers to medical devices whose safety and effectiveness should be controlled. Generally, the provincial food and drug supervision and administration bureau is responsible for approving and issuing registration certificates. For example: thermometers, blood pressure monitors, condoms (condoms), etc. The country has issued two batches that do not require application《Medical Device Operating Enterprise License》The second category of medical devices, with a first batch of thirteen, includes thermometers, blood pressure monitorsMedical degreasing cottonMedical degreased gauze, medical hygiene masks, magnetic therapy equipment, household useblood glucose meterBlood glucose test strips, pregnancy diagnostic test strips (early pregnancy test strips), condomsContraceptive capWheelchairs, medical sterile gauze. There are six products in the second batch that do not require the application for a Medical Device Business License:Electronic blood pressure and pulse meterPlum blossom needle, triangular needle, acupuncture and moxibustion needle, ovulation test paper, portable oxygen generator.
Three types of medical devicesIt refers to implantation into the human body; Used to support and sustain life; Medical devices that pose potential risks to the human body and require strict control over their safety and effectiveness. Usually byState Food and Drug AdministrationTo approve and issue registration certificates.