China Tightens Regulations On Radiofrequency Beauty Treatment Devices
2023-11-20
In a significant regulatory update, China’s National Medical Products Administration (NMPA) has announced a comprehensive overhaul of the classification and supervision of radiofrequency (RF) beauty treatment devices. The changes mark a transition from lenient oversight to stringent regulation, aligning with the administration’s commitment to ensuring consumer safety and product efficacy.
The regulatory history of radiofrequency (RF) beauty treatment devices in China can be summarized as follows:
Initial Non-Medical Device Classification (2004-2012): Initially, devices such as “beauty wrinkle removers” were classified as non-medical devices by the Chinese regulatory authorities. This classification meant that they were not subject to the stringent regulations that apply to medical devices.
On August 6, 2004, CFDA document number [2004] 385, the “beauty wrinkle remover” was defined as a non-medical device.
On December 10, 2012, CFDA document number [2012] 361, the “skin beauty device” was defined as a non-medical device. The description of the device includes a main unit and accessories, such as an ultrasonic probe, high-frequency pulse probe, iontophoresis probe, exfoliation probe, and far-infrared probe. It is not used for medical purposes and is only used for facial cleansing, exfoliation, wrinkle removal, pigment lightening, and skin tightening.
Transition to Class II Medical Device Supervision (2017): In 2017, the Chinese regulatory body, which was then known as the State Food and Drug Administration, reclassified RF superficial treatment devices as Class II medical devices. This reclassification marked the beginning of more stringent oversight, as Class II devices are subject to greater regulatory controls than non-medical devices, including requirements for registration and compliance with certain standards.
On August 31, 2017, in Announcement No. 104 of 2017, “The Administration’s Announcement on the Release of the Medical Device Classification Catalog,” radiofrequency superficial treatment devices were for the first time explicitly regulated as Class II medical devices.
On September 4, 2017, in Announcement No. 143 of 2017, “The Administration’s Notice on Implementing the <Medical Device Classification Catalog> and Related Matters,” it was explicitly stated that from the time of the catalog’s release, the classification results in the catalog are to be considered accurate, and previous classification results are invalid.
Experimentation with Mixed Class II and III Management (2021): In April 2021, the National Institutes for Food and Drug Control issued a draft for comment that proposed classifying RF beauty products as either Class II or Class III medical devices. The classification was to be based on factors such as the depth of energy penetration and the potential harm to the human body. This indicated a move towards even stricter regulation, as Class III devices are subject to the highest level of regulatory control.
Adoption of Class III Medical Device Supervision (2022): In March 2022, the National Medical Products Administration (NMPA) announced that all RF skin treatment devices would be regulated as Class III medical devices. This classification subjects these devices to the most rigorous regulatory requirements, including pre-market approval and quality control measures. Additionally, it was mandated that from April 1, 2024, only enterprises with medical device production qualifications would be allowed to manufacture and sell these products.
Throughout the regulatory history, the Chinese authorities have adjusted their approach to the oversight of RF beauty treatment devices, gradually moving from a more lenient classification to a more stringent one, reflecting an increased focus on consumer safety and product efficacy. Manufacturers have been given transition periods to comply with the new regulations.
BradyKnows Medical will continue to monitor these developments and provide updates on how these changes impact manufacturers and consumers in the beauty treatment device industry.
For more information on the evolving regulatory landscape for medical devices in China, stay tuned to BradyKnows Medical via info@bradyknowsmedical.com.
