This year, CCTV 3·15 Evening Party once again exposed the chaos in medical aesthetics industry, with cosmetic products being used for injections. The program revealed that certain manufacturers were selling products originally classified as Class III medical devices as cosmetic products at large exhibitions.
Cosmetic products are only intended for use on the surface of the skin and should not be injected. According to the regulations of the National Medical Products Administration (NMPA), injectable filler medical aesthetic products, such as hyaluronic acid and mesotherapy are classified as Class III medical devices. Compared to cosmetic products, medical devices have longer research and development cycles and require significant funding, often involving animal experiments and clinical trials to verify safety and efficacy. Only those with the certification of Class III medical device, can be sold and used.
In recent years, the medical aesthetics industry has experienced rapid growth, but with it comes the proliferation of illegal activities, such as unlicensed business practices, operating beyond authorized areas, and using unapproved drugs and medical devices. These illegal activities pose a serious threat to the health, safety, and financial well-being of consumers.
To further regulate the operation and use of medical aesthetic products, on May 28, 2021, the National Health Commission NMPA, and six other departments jointly issued a notice titled "Special Campaign to Crack Down on Illegal Medical Aesthetic Services". The notice stipulated that the special campaign would be carried out nationwide from June to December 2021.
In December 2022, the NMPA reported seven typical cases of illegal medical aesthetic drugs and devices, all of which involved operating without proper certification or qualifications.
In addition to injectable filler products, injection equipment and beauty devices used in medical aesthetics are also belong to medical devices, as follows：
The following are some adjustments to medical aesthetic devices management categories and regulatory requirements:
In May 2018，the NMPA classified "portable intense pulsed light hair removal" as Class II medical devices, and required that since January 1, 2023, products in this category must obtain medical device registration certificates in order to be manufactured, imported and sold legally.
In March 2022，the NMPA classified facial implant threads/lifting threads and mesotherapy (sodium hyaluronate solution) as Class III medical devices. Radiofrequency skin treatment devices were also classified as Class III medical devices, and as of April 1, 2024, products in this category must obtain medical device registration certificates in order to be manufactured, imported, and sold legally.
As more regulatory policies are put in place, we can expect to see more nationwide joint efforts to crack down on illegal activities and promote greater regulation and safety in the medical aesthetics industry, ultimately protecting the health and financial well-being of consumers.
Information source: Regulatory policies and cases are sourced from the NMPA official website
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As a CRO company providing clinical trial services. LINKS CRO focus on innovation, high-risk implantation(intervention) medical device, with one-stop clinical trial solutions for the whole process of medical device research and development.The headquarters of LINKS is based in Shanghai, with subsidiary branches in Beijing, Shanghai, Guangzhou, and Shenzhen, in addition to ten regional offices. The current workforce comprises almost 200 employees, with technical personnel making up over 85% and dispersed across almost 30 cities nationwide.
Key Services include CRO, SMO, CER, Audit, Post-market research, core laboratory registration both domestically and overseas, innovation declaration, Expert Consultancy, and overseas enterprise agency services.
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