Considering the fact that Radio Frequency (RF) technology products are widely used in daily life and medical applications, the NIFDC (National Institute for Food and Drug Control) announced the technical guidelines (draft) for the product classification of radio frequency beauty products on April 16, 2021. Once implemented, RF devices for beauty treatments will very likely be regulated as class II or class III medical devices.
The draft proposes how the scope and classification would apply to RF beauty devices as below:
Product Scope
– Products using radio frequency energy on the human body (including but not limited to skin tissues and deep subcutaneous soft tissues) to achieve mild heating of the upper skin layer, improve blood circulation, etc.
– Products using radio frequency energy on the human body (including but not limited to skin tissues and deep subcutaneous soft tissues) to achieve human tissue, cellular pathology or physiological changes that may potentially impact or injure the body (such as edema, erythema, burns, microscopic scarring, subcutaneous fat necrosis collapse and other clinical conditions)
– Products that may directly be used for lipolysis, shaping, scar treatment, obvious changes in skin quality or other medical treatments that may potentially impact or injure the body (such as immediate tissue contraction reaction, tissue degeneration, cell apoptosis, etc.)
Classification of RF beauty products
Class II
Products emitting radio frequency energy that only reaches the dermis layer of the skin for the purpose of:
– mild heat generation
– improving blood circulation
without
– injuring the tissues below the dermis layer
– causing sudden reaction of tissue contraction
– degenerating the skin tissue or skin cells
– causing irreversible thermal injury (above first-degree burn)
Class III
Products emitting radio frequency energy that reaches below the dermis layer of the skin including the oral cavity and mucosa, or products using harmful treatment methods (potentially causing injuries to the skin) for the purpose of achieving human tissue, cellular pathology or physiological changes that may potentially impact or injure the body with the following results:
Edema or damage the barrier functions of the skin (dry or sensitive skin);
– Pain to the skin;
– First-degree burn or above (showing erythema reactions to the skin);
– Hyperpigmentation;
– Scarring; or
– Blisters
High-energy radio frequency products that may directly be used for lipolysis, shaping, scar treatment, obvious changes in skin quality or other medical treatments that may potentially impact or injure the body with the following irreversible results:
– Immediate tissue contraction reaction;
– Tissue degeneration;
– Cell apoptosis;
– Cell ablation; or
– Cell coagulation
The NIFDC is currently soliciting public comments on the draft until May 3, 2021.
By Jacky Li. Contact Cisema if you would like to learn more.
