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RF beauty equipment will be included in three types of medical devices

The New Year is approaching, less than 4 months from the radio frequency beauty equipment into the supervision of three types of medical devices, some brand businesses are rushing to clean up the inventory before the landing of the new regulations, and some brands are applying for Class III medical device qualifications.

So what does radio frequency beauty equipment specifically refer to?

Step 1: Purpose

In order to further standardize the management of RF beauty equipment, the National Food and Drug Administration organ Audit Center has organized the formulation of the "Guiding Principles for the Registration Review of RF beauty Equipment".

2. Definition:

The RF beauty equipment mentioned in the principle refers to the use of RF current of a specific frequency (usually more than 200kHz) or electric field (usually 13.56 or 40.68MHz) and other electrical energy acting on human tissues to produce thermal effects, in order to treat skin relaxation, reduce skin wrinkles, shrink pores, tighten/enhance skin tissue, or treat acne, scars, etc. Or devices that reduce fat (fat softening or decomposition) and other effects. These devices will be in accordance with the requirements of the announcement of the State Food and Drug Administration on the adjustment of part of the content of the "Medical Device Classification Catalogue", the classification code is 09-07-02, and the management is according to the third class medical devices.

3. Relevant standards:

Electromagnetic compatibility shall comply with the requirements of YY 9706.102 (YY 0505) standard.

Electrical safety, should meet the requirements of GB 9706.1 standard.

BTL Testing Group covers electromagnetic compatibility, safety, reliability, chemistry, mobile communication and other testing fields, and has rich execution experience, and can provide preliminary testing and mapping services for the majority of RF beauty brands to reduce the risk of failing tests submitted for approval. Welcome to inquire.


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