A food and drug administration received a report that the "multifunctional laser comb" sold by a production enterprise through the Internet has the effect of "growing hair and thickening hair" in advertising, and the product structure and expected use should belong to the second-class medical device (0903-0 1) laser treatment equipment. The manufacturer has not obtained the registration certificate of "Multifunctional Laser Comb" medical devices, which is suspected of violating the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the Regulations).
After investigation, the company has a medical device production license, engaged in the production and sales of "laser therapy equipment" products with medical device registration certificate, and also produced and sold electronic products "multifunctional laser comb" without medical device registration certificate. The product of "Multifunctional Laser Comb" has been tested and put on record by the local Bureau of Quality and Technical Supervision, and the enterprise standard of the product has been formulated, which meets the requirements of the production and sales of electronic products. There is no expression of the effect of "hair growth and secret hair" in the product appearance information and instructions, but there is propaganda of "hair growth and secret hair" on the web page of online sales.
divergence
Whether the above-mentioned behavior of enterprises is illegal or not, and how to deal with it, there are differences among law enforcement personnel.
The first view is that the behavior of enterprises is not illegal. The reason is that electronic products have been tested and filed by the Quality Supervision Bureau, and the product enterprise standards have been formulated, which meets the requirements of electronic product production and sales; The product appearance information and instructions do not describe the intended use of "Hair Growth and Dense Hair", and do not describe the process and results of disease diagnosis and treatment, application scope and other information. In addition, the State Administration of Medical Supplies has not clearly stipulated that this product belongs to medical devices, so it cannot be recognized as the second class of medical devices, so there is no unlicensed production in the production and sales of this product. As for the product online sales page with "secret hair growth" propaganda, it should be regarded as the advertising language used in electronic product sales, which may be suspected of exaggerating propaganda.
The second view is that "multifunctional laser combs" should be managed as medical devices, and the behavior of enterprises violates the provisions of Item (1) of Paragraph 1 of Article 81 of the Regulations. Article 103 of the Regulations stipulates that "medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including necessary computer software; Its utility is mainly obtained through physical means, not through pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role "; The purposes of medical devices are "diagnosis, prevention, monitoring, treatment or mitigation of diseases" and "diagnosis, monitoring, treatment, mitigation or functional compensation of injuries". The practical way of "multifunctional laser comb" is mainly obtained by the physical way of laser with wavelength of 650nm, and the expected purpose is to "grow hair and thicken hair", which is consistent with the purpose of the above medical devices.
In addition, according to the product description of "0903-0 1 Laser Treatment Equipment" in the Catalogue of Medical Devices, "the mechanism of photochemical or biological stimulation between low-level laser and human tissues is used to achieve the purpose of treatment", which is consistent with the above description and conforms to the meaning of medical devices in the first paragraph of Article 103 of the Regulations, and should be managed as the second type of medical devices.
Comment and analysis
Support the first view, the product does not belong to medical devices. The reasons are as follows.
First of all, whether a product belongs to a medical device needs to be judged from the fact, that is, from the appearance and expected use of the product. Product appearance information, including name, label and instructions, marked as medical devices; The expected purposes include product labels, instructions for use, operation manuals and other technical materials. And whether the logo has the intended use of medical devices. The appearance information and intended use of the products involved are not identified as medical devices.
Second, legal judgment is needed. Whether a product belongs to a medical device or not is mainly based on the provisions of Article 103 of the Provisions on the Meaning of Medical Devices. The main basis for determining what kind of medical device the product belongs to is as follows: First, the Classification Rules of Medical Devices and its annex, the Classification Judgment Table of Medical Devices, are clearly defined; The second is the classification catalogue of medical devices; In addition, National Medical Products Administration also issued the definition and classification documents of whether some products are used as medical device management. The technical principle and characteristics of the products involved meet the requirements of the meaning of medical devices, and the product description is consistent with "0903-0 1 laser therapy equipment" in the Catalogue of Medical Devices, but the expected use and use of the products have changed substantially, so it is impossible to identify them as medical devices.
Third, it should be judged according to the risk degree of medical devices. Article 6 of the "Regulations" makes it clear that the state implements classified management of medical devices according to the degree of risk; To evaluate the risk degree of medical devices, the expected use, structural characteristics and use methods of medical devices should be considered. Because there is no similar medical device with hair growth function, there is no similar medical device standard for this product. The structural feature of this product is the use of weak laser, and the use method is external use. Comprehensive judgment shows that the risk is low and the expected clinical effect is not easy to judge. So this product is more suitable to be defined as an electronic product.
In addition, the determination of product categories involved in daily supervision and inspection, complaints and reports shall be judged by the local provincial drug regulatory authorities according to the actual situation, and the classification definition may also be applied according to the Notice on Standardizing the Classification of Medical Device Products issued by the former General Office of the US Food and Drug Administration.
To sum up, the definition of medical devices needs to be comprehensively considered from the aspects of fact judgment, legal judgment and risk degree. In this report, the daily-use electronic products produced by enterprises do not identify the name and purpose of medical devices, and there are no similar medical device products on the market. Considering the expected use, structural characteristics, methods of use and other factors, it is a low-risk and unclear product, so it is not recognized as a medical device.
The behavior of "secret hair growth" in enterprise advertisements needs to be investigated by market supervision departments. If the illegal facts of false advertising are found, the enterprise violates Article 28 of the Advertising Law of People's Republic of China (PRC) and shall be punished according to the provisions of Article 55 of the Advertising Law; False advertisements that harm consumers' rights and interests shall be ordered to pay compensation in accordance with the provisions of Articles 52 and 55 of the Law of People's Republic of China (PRC) on the Protection of Consumers' Rights and Interests.