Eight Ministries Issue Joint Notice to Strengthen Comprehensive Regulation and Law Enforcement in the Medical Aesthetics Industry
On April 27, eight departments, including the General Office of the National Health Commission, the Secretariat of the Cyberspace Administration of China, the General Office of the Ministry of Education, the General Office of the Ministry of Public Security, the General Office of the Ministry of Commerce, the General Office of the General Administration of Customs, the General Office of the State Administration for Market Regulation, and the Comprehensive Department of the National Medical Products Administration, jointly issued the “Notice on Further Strengthening Comprehensive Supervision and Law Enforcement in Medical Aesthetics” (Guo Wei Ban Jian Du Fa [2020] No. 4).
Notice Addressing the Recent Resurgence of Irregularities in Medical Aesthetics: It Emphasizes Strengthening the Primary Responsibility of Self-Regulation for Medical Institutions Providing Aesthetic Services, and Proposes Three Key Measures—Standardizing Medical Aesthetic Services, Regulating the Production, Distribution, and Use of Pharmaceuticals and Medical Devices, and Standardizing the Publication of Medical Aesthetic Advertisements.
Furthermore, the Notice proposes additional measures, including leveraging the self-regulatory role of industry associations, enhancing inter-departmental coordination to strengthen government oversight, and reinforcing public supervision, with the aim of purifying the medical aesthetics market.
In response to the irregularities in the medical aesthetics industry, seven departments, including the former National Health and Family Planning Commission, jointly deployed a one-year special campaign from 2017 to 2018 to severely crack down on illegal medical aesthetic practices, achieving certain results. Recently, supervision has revealed a resurgence of such irregularities. To further purify the medical aesthetics market, safeguard the public’s physical health and life safety, and implement the requirements of the “Guiding Opinions of the General Office of the State Council on Reforming and Improving the Comprehensive Supervision System for the Healthcare Industry” (Guo Ban Fa [2018] No. 63), notice is hereby given on strengthening comprehensive regulatory enforcement in medical aesthetics:
(I) Standardize medical aesthetic services.Medical aesthetic services shall be provided within medical institutions that have lawfully established relevant medical aesthetic specialties, in accordance with the filed medical aesthetic service items, and shall be implemented by attending physicians or by licensed physicians under the supervision of attending physicians.No entity or individual shall provide medical aesthetic services without meeting the statutory requirements. Medical aesthetic institutions and medical personnel must fulfill their primary responsibility for self-management, conduct self-inspections and rectifications of lawful practice as required, and promptly report on the status of such self-inspections and rectifications. They shall prioritize medical quality and safety, and standardize medical aesthetic service practices in accordance with relevant regulatory standards.
(II) Standardize the production, distribution, and use of drugs and medical devices. Drugs marketed within China, as well as Class II and Class III medical devices, are subject to product registration management; products without registration approval shall not be marketed. Entities that have not legally obtained the necessary qualifications for the production or distribution of drugs and medical devices shall not engage in such activities. Manufacturers and distributors of drugs and medical devices shall strengthen management in accordance with the requirements of laws and regulations such as the Drug Administration Law and the Regulations on the Supervision and Administration of Medical Devices, produce in compliance with the law, and operate lawfully. They shall not sell drugs and medical devices to user entities lacking valid qualifications.Medical aesthetic institutions shall purchase drugs and medical devices from enterprises qualified for production and operation, implement incoming inspection systems, ensure rational use according to indications, and strictly control the use of toxic drugs and narcotic drugs.
(3) Regulate the publication of medical aesthetics advertisements. Medical aesthetics advertisements are classified as medical advertisements; non-medical institutions are prohibited from publishing medical advertisements.Medical aesthetic institutions shall publish medical aesthetic advertisements in accordance with the provisions of the Advertising Law and the Measures for the Administration of Medical Advertisements. Such advertisements must be reviewed by the health administrative department and published strictly in accordance with the approved content. Institutions are prohibited from altering the content of the Medical Advertisement Review Certificate when publishing advertisements, from publishing or disguising medical advertisements through news formats or special medical information service programs (columns), and from engaging in false advertising.
All regions and departments should actively foster the growth and development of industry organizations related to medical aesthetics and lifestyle beauty, such as associations and societies. Further streamlining administration and delegating power is required to support these industry organizations in playing their role in self-regulation. Communication and collaboration with relevant industry organizations should be strengthened, enhancing information sharing and coordinated supervision, while taking industry self-regulation performance as an important reference for regulatory purposes.
Industry organizations at all levels related to medical aesthetics shall further improve industry management, strengthen the formulation, revision, and implementation of group standards for medical aesthetics, and promote the institutionalization of industry self-discipline. They shall enhance self-discipline, self-inspection, training, and guidance for industry members, urge them to effectively strengthen medical quality and safety management, conduct regular self-inspections and rectifications to ensure lawful practice, and strictly adhere to legal requirements. Through lawful credit evaluations and other measures, they shall further improve and innovate methods of industry self-regulation. Additionally, they shall strengthen public science education and regularly release typical cases or incidents in medical aesthetics, as well as risk warnings regarding medical aesthetic procedures and the use of pharmaceuticals and medical devices.
Industry associations related to lifestyle beauty at all levels shall conduct grassroots legal publicity and education, strengthen self-discipline guidance and risk warnings for lifestyle beauty establishments, and urge member entities to learn from cases of illegal provision of medical aesthetic services by such establishments, ensuring lawful and standardized operations without engaging in any medical aesthetic procedures.
All regions and departments must strengthen inter-departmental coordination, improve mechanisms for information sharing between departments, innovate regulatory measures, enforce strict supervision and law enforcement, enhance the linkage between administrative law enforcement and criminal justice, and severely crack down on illegal medical aesthetic practices.
Health administrative departments must strictly regulate the approval and verification management of medical aesthetic institutions. Medical aesthetic departments shall be classified under secondary-level clinical specialties, file records for medical aesthetic service items as required, and resolutely handle non-compliant institutions in accordance with laws and regulations. Information disclosure and sharing should be strengthened by integrating electronic registration data of medical institutions, physicians, and nurses into the credit information sharing platform of national health administrative authorities. The system for querying information on medical institutions and physicians shall be continuously improved to promote the public disclosure of practice information by medical aesthetic institutions. Medical quality control organizations at all levels should leverage their roles to enhance medical quality and safety management, intensify supervisory law enforcement, severely crack down on unlicensed medical practices, and seriously investigate and penalize illegal or non-compliant practice behaviors by medical aesthetic institutions and medical personnel.
Cyberspace administration authorities shall, in accordance with the law, handle adverse information related to internet-based medical aesthetics as identified by relevant departments, and investigate and penalize websites that violate laws and regulations.
Education authorities shall collaborate to strengthen public science education and guide the public to seek medical care safely.
Public security organs shall strengthen coordination and cooperation with relevant departments, and severely crack down on criminal activities such as the production and sale of counterfeit and substandard drugs, as well as illegal medical practice, in accordance with the law.
Commerce departments must urge e-commerce platforms to strictly fulfill their primary responsibilities and, in accordance with the principle of consistency between online and offline operations, require third-party platforms to cooperate with relevant authorities in strengthening oversight of in-platform merchants selling medical aesthetic drugs and medical devices, as well as their associated products and services.
Customs authorities shall strengthen supervision over the import of pharmaceuticals and medical devices, and severely crack down on illegal activities such as smuggling of pharmaceuticals and medical devices.
Market supervision and administration departments shall conduct random inspections of lifestyle beauty establishments in accordance with the “double-random, one-public” mechanism, and promptly notify health administrative authorities when such establishments are suspected of providing medical aesthetic services without proper qualifications during routine supervision. Strengthen oversight of price violations and unfair competition practices in the medical aesthetics industry. Enhance regulation of medical aesthetic advertising, and investigate and penalize false or illegal medical aesthetic advertisements in accordance with the law.
Drug regulatory authorities (or departments assuming drug regulatory responsibilities) shall strengthen supervision and inspection of drug and medical device manufacturers, distributors, and medical institutions in accordance with their duties, and investigate and penalize drugs and medical devices that fail to meet statutory requirements in accordance with the law.
All regions and departments must implement the requirements of the administrative law enforcement publicity system, further strengthen information disclosure, and promptly publish administrative law enforcement information related to medical aesthetics—such as administrative licensing, inspections, and penalties—on influential local media outlets, websites, and the official websites of administrative authorities. Medical aesthetic institutions shall timely and comprehensively disclose practice-related information concerning medical aesthetic services to facilitate public inquiry.
All regions and departments must further intensify efforts to promote laws, regulations, and public science education related to medical aesthetics. Through diverse channels and methods, widespread publicity should be conducted to enhance the awareness of lawful practice among medical institutions and healthcare professionals, improve the public’s awareness of safe medical care, and strengthen their ability to identify legitimate services.
Actively promote and advocate that individuals seeking medical aesthetic services choose licensed medical institutions and qualified practitioners, proactively verify the credentials of medical aesthetic institutions, request medical records and receipts, consciously refrain from receiving medical aesthetic services provided by non-medical institutions or unlicensed personnel, reject counterfeit, substandard, “three-no” products (no manufacturer name, no production date, no quality certification), or medical aesthetic drugs and devices of unknown origin, and promptly report any illegal activities to the relevant authorities.
All localities and departments must strengthen public oversight, explore the establishment of a reward-based system for complaints and reports regarding medical aesthetics, broaden channels for such complaints and reports, and improve mechanisms for public supervision. Upon receiving complaints or reports, each department shall promptly verify those falling within its jurisdiction, handle them strictly in accordance with the law, and provide timely feedback on the outcomes to the concerned parties; for matters falling under the jurisdiction of other departments, they shall be promptly transferred or referred to the relevant departments for verification and handling.
Source: Bureau of Comprehensive Supervision, National Health Commission