On March 3, less than a month after the RF instrument and RF instrument products were included in the management of the third class of medical devices. There are three main categories of medical devices, namely Class I, Class II and Class III. Among them, the first category is the filing system, which has a low threshold. Clinical trials are required to apply for Class III medical devices, and the current production of household RF beauty devices is basically engaged in the field of home appliances and has no background and experience in registering Class III medical device products. It is foreseeable that most of the small and medium-sized RF beauty device companies that do not have the strength of R&D funds will withdraw from the market in this adjustment. With the RF beauty device clearly in accordance with the medical device supervision, the entire market will usher in great changes.
From "small household appliances" to "medical devices".
The medical standard is higher than the standard of household appliances. After the implementation of the new regulations, all products must meet the requirements of domestic medical device supervision before they can be marketed. Previously, household radio frequency beauty instrument products are managed in accordance with the market standard of "small household appliances", according to the Food and Drug Administration 2014 No. 198 document, high-frequency ** beauty instrument is not managed as a medical device, the document on the "high-frequency ** beauty instrument" The definition of "mainly composed of the host, high-frequency transmitter, power cord and stylus." Radiofrequency technology is used to act on the human body to achieve the contraction of collagen fibers and the deposition of new collagen fibers, and increase the elasticity of collagen fibers. For tightening sagging, reducing wrinkles and folds, and improving appearance".
The home RF beauty instrument market is developing rapidly, and according to public statistics, the market size of China's home RF beauty instrument has exceeded 10 billion. In March 2022, the State Food and Drug Administration issued an announcement (No. 30 of 2022) on adjusting part of the content of the "Classification Catalogue of Medical Devices", clarifying that radio frequency and radio frequency instruments are included in the management of the three categories of medical device catalogs, and from April 1, 2024, enterprises that have not obtained medical device production and business licenses (filing) shall not engage in the production and sales of related products.
In April 2023, the Center for Medical Device Technology Evaluation of the State Food and Drug Administration issued the "Guiding Principles for the Registration and Review of Radio Frequency Beauty Devices", which clarified that the classification code of radio frequency beauty devices is 09-07-02 and is managed as Class III medical devices, and clarifies the specific requirements such as the key points of registration review, main risk points, and applicable standards for such products. Among them, the clinical evaluation requirements mention that radio frequency beauty equipment is not a product that is exempt from clinical evaluation, and clinical evaluation should be carried out with reference to the recommended path for clinical evaluation of related products in sub-catalog 09 "physical ** device" of the "Medical Device Classification Catalog".
Liang Hong, a reviewer of the second review department of the instrument review center, said that handheld household radio frequency beauty equipment usually has a low output energy and is used by users in the home environment, but it can be seen from the problems found before such as scalding, leakage, poor contact, and excessive heavy metals that such products have certain safety risks, so they are unified into the management of Class III medical devices, and further refine the requirements for the safety and effectiveness of products. Li Ting, director of the Technical Regulations Department of the Guangdong Research Institute of New Biomaterials and High-end Medical Devices, believes that China's inclusion of household radio frequency beauty products in the third class of medical devices for supervision means that the market access threshold requirements have been increased.
The market reshuffle intensified.
After the release of the "Guidelines for the Registration and Review of Radio Frequency Beauty Devices", domestic manufacturers began to sort out the information and submit registration applications to the State Food and Drug Administration. However, the current production of household radio frequency beauty equipment enterprises, originally basically engaged in the field of home appliances. A person engaged in household radio frequency beauty devices bluntly said to a reporter from Beijing Business Daily that "the process is crossing the river by feeling the stones".
A reporter from Beijing Business Daily learned that the registration process of the three types of medical devices mainly includes the optimization of product design, development and optimization in accordance with the medical standard period, the completion of medical device registration test reports, clinical trials and registration review by the State Bureau. Among them, the time for product design, development and optimization according to the medical standard period is 6-12 months; The clinical trial takes 12-24 months; The medical device registration test report includes safety test, EMC test and full performance test, which takes 4-8 months.
The relevant person in charge of a domestic medical device company told a reporter from Beijing Business Daily that it takes a long time to apply for Class III medical devices from submission of registration to application. It takes half a year from the submission of the registration to the first supplement, which is to supplement the research materials or demonstration data. The defense process takes about 3 months. There are still administrative approval and other processes, and if you are constantly required to supplement the order, it will take about 2-3 years.
The EU actually has similar regulatory policies," according to Su Jing, secretary-general of Tsinghua University's Center for Global Development and Health Communication, but the EU's transition period is five years before the policy is officially implemented. "After the issuance of the new regulations, we immediately began to prepare for the registration of Class III medical devices," according to a relevant source from a domestic RF beauty device manufacturer. The person bluntly said that in accordance with the procedures and timeliness stipulated in the "Administrative Measures for the Registration and Filing of Medical Devices", it will take about 3 to complete the entire processFor more than 5 years, it is objectively impossible to obtain the registration certificate of Class III medical devices before April 1, 2024.
In addition to time, funding is also a challenge. It has been revealed that the application cost of Class III medical devices is millions of yuan. Li Ting said that there are some differences in the supervision of RF beauty products in the world, and the United States will supervise household RF beauty products according to Class II medical devices; The European Union classifies it as a Class IIA (Class II medical device with the same level of risk). China has included household radio frequency beauty products in the third class of medical devices for supervision, and the market access threshold requirements have been raised. The safety, effectiveness and controllability of the whole life cycle of medical device products are the core, which means that the design and production of medical device products put forward high requirements for the professionalism, technology and understanding of relevant regulatory policies. In addition, relevant enterprises also need to have strong financial strength and management capabilities. Beijing Business Daily reporter Yao Qian.