China Likely to Manage Portable RF Machines as Medical Devices

China NIFDC promulgated the draft Guidelines for Defining the Classification of Radio Frequency Products, which defines three types of radio frequency products as medical devices. The industry estimates that portable RF machines may belong to the first type of RF products and will be managed as medical devices.

Recently, China National Institute for Food and Drug (hereafter referred to as NIFDC) promulgated the draft Guidelines for Defining the Classification of Radio Frequency Products (hereafter referred to as the Guidelines) for public consultation. The Guidelines was released to standardize the management of all products that use radio frequency to achieve the purpose of medical beauty.

As per the Guidelines, the following three types of radio frequency products are all defined as medical devices and subject to the management of category II or III of medical devices.

Type	Product Description
1	The RF products that use radio frequency energy to act on the human body (including but not limited to skin tissue, deep subcutaneous soft tissue, etc.) to apply hot compress through local superficial gentle heating, improve blood circulation, etc.
2	The RF products that use radio frequency energy to act on the human body (including but not limited to skin tissue and deep subcutaneous soft tissue, etc.), to cause pathological/physiological changes in tissues and cells, and may cause potential impact or damage to the human body (such as edema, erythema, burn, micro scar, subcutaneous fat necrosis or collapse, and other possible clinical diseases)
3	The RF products that are directly used for (including but not limited to) fat-dissolving, shaping, scar treatment, an obvious change of skin quality or other medical treatments, and may cause potential impact or damage to the human body (such as immediate tissue contraction response, tissue degeneration, cell apoptosis, etc.)

Table 1 Three Types of RF Products

According to China's medical device regulation, medical devices are divided into 3 categories: I, II and III. Category II and III require clinical testing, and registration with the provincial Medical Products Administration (commonly abbreviated as MPA) and National Medical Products Administration (commonly abbreviated as NMPA) respectively, while category I only require filing. Therefore, all the above-mentioned RF products require clinical testing and registration.

The Guidelines have generated widespread buzz in the industry. It is estimated that the portable RF machines likely belong to the first type of RF products (see Table 1) and will obviously be managed as medical devices. Currently in China, the majority of portable RF machines are managed as small household electrical appliances, which are subject to far less requirements than that for medical devices and do not require mandatory testing. If the portable RF machines are categorized as medical devices, there will be a tremendous impact and great burden on related companies. They will face a high cost of clinical testing, strict product and registration requirements, complicated document preparation, and a time-consuming registration process. But according to usual practice a transition period should be granted for companies before full implementation.