Case
A local drug administration bureau received a report that a manufacturer through the network sales of a "multi-functional laser comb", advertised on the "hair growth and dense hair" effect, the structure and intended use of the product should belong to the second class of medical devices (0903-01) laser therapy equipment, the manufacturer did not obtain a "multi-functional laser comb" medical device registration certificate, allegedly in violation of the "Medical Device Supervision and Control" medical device registration certificate. Medical device registration certificate of the second class, the third class of medical devices".
Investigated, the enterprise has a medical device production license, engaged in the production and sale of medical equipment registration certificate "laser therapy equipment" products, but also the production and sale of electronic products without a medical device registration certificate "multi-function laser comb The "multifunctional laser comb". The "multifunctional laser comb" products by the local quality and technical supervision testing and record, the development of the product enterprise standards, in line with the requirements of the production and sale of electronic products; product appearance information and instructions for use of the product does not have "hair dense hair" efficacy of the expression, but its web page in the network sales have "hair dense hair". There is no "hair growth and dense hair" in the product appearance information and instruction manual, but there is "hair growth and dense hair" publicity on the web page of network sales.
Disagreements
Law enforcement officials were divided on whether the company's behavior was illegal and how it should be handled.
The first point of view that the enterprise behavior is not illegal. The reason is that the electronic products by the Quality Supervision Bureau testing and record, the development of the product enterprise standard, in line with the requirements of the production and sale of electronic products; the product appearance information and instructions for the expected purpose of no "hair dense hair" expression, there is no diagnosis and treatment process and results of disease, the scope of application and other information expression. In addition, the State Drug Administration did not specify the classification of the product is a medical device, so the product can not be recognized as a Class II medical device, so the production and sale of the product does not exist without a license. As for the product online sales page on the "hair dense hair" publicity, should be regarded as an electronic product sales advertisement, may be suspected of exaggerated publicity.
The second view is that the "multi-functional laser comb" should be managed as a medical device, and the enterprise's behavior violates the provisions of Article 81(1)(a) of the Regulations. Article 103 of the Regulations stipulates that "medical devices refer to instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related articles used directly or indirectly in the human body, including the required computer software; their utility is mainly obtained through physical means, not through pharmacological, immunological or metabolic means, or Although these modalities are involved, they play only an auxiliary role"; the purpose of medical devices is "diagnosis, prevention, monitoring, treatment or alleviation of disease", "diagnosis, monitoring, treatment, alleviation or functional compensation of injury", etc. The purpose of medical devices is "diagnosis, prevention, monitoring, treatment or relief of disease", "diagnosis, monitoring, treatment, relief or functional compensation of injury", etc. "Multifunctional laser comb" utility pathway is mainly through the wavelength of 650nm laser physical means, the intended purpose of "hair growth and dense hair", and the purpose of the aforementioned medical device is consistent.
Additionally, according to the product description of "0903-01 laser therapy equipment" in the "Classification Catalog of Medical Devices", "the use of weak lasers and human tissues of photochemical or biostimulation mechanism, to achieve the therapeutic purpose", the product is consistent with the above description, and complies with the provisions of the Regulations, and is also consistent with the purpose of the medical device. This product is consistent with the above description and conforms to the meaning of Article 103(1) of the Regulations on medical devices, and should be managed as Class II medical devices.
Analysis
Supporting the first point of view, the product is not a medical device. The reasons are as follows.
First of all, as to whether the product is a medical device, it is necessary to make a factual determination, i.e., from the appearance of the product, the intended purpose of the two aspects of the determination. Product appearance information, including the name, labeling and instructions for medical devices; intended purpose of the product, including labeling, instructions for use, operating manuals and other technical information, whether the intended purpose of medical devices. The product appearance information, intended purpose are not identified as a medical device.
Second, the need for legal determination. Whether the product is a medical device, the main legal judgment is based on Article 103 of the Regulations on the meaning of medical devices. Determine the product belongs to what category of medical devices, the main basis for a "Medical Device Classification Rules", the annex "Medical Device Classification Table" for clear provisions; second is the "Medical Device Classification Catalog"; in addition, the State Drug Administration has issued a part of the product as a medical device management of the definition and categorization of the document. The technical principles and characteristics of the product in question meet the requirements of the meaning of medical devices, and the description of the product is consistent with the "0903-01 laser therapy equipment" in the "Classification Catalog of Medical Devices", but the intended purpose of the product, the use of the product has changed substantially, and it cannot be determined that it is a medical device.
Third, should be based on the degree of risk of medical devices. Article 6 of the Regulations makes it clear that the state of medical devices in accordance with the degree of risk of the implementation of classification and management; evaluation of the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, methods of use and other factors. As there is no similar medical device with hair growth function, there is no comparable medical device standard for this product to refer to. The product's structural features utilize weak laser light, and the method of use is external, which comprehensively determines that its degree of risk is low, and the expected clinical effect is not easy to determine. Therefore, this product is more appropriately defined as an electronic product.
In addition, for routine supervision, inspection, complaints and reports involving the determination of product categories, the local provincial drug regulatory authorities to make a determination based on the actual situation, but also in accordance with the former State Food and Drug Administration General Office of the standardization of medical device product classification of the relevant work of the notice, the classification of the definition of the application.
In summary, the definition of medical devices need to be determined from the fact that the judgment, the legal judgment, the degree of risk and other aspects of the comprehensive consideration. The report of the company's production of daily electronic products, not identified medical device name and utility, the market is no similar medical device products, from the intended purpose, structural features, methods of use and other factors to consider a low degree of risk, the effect can not be clear products, so do not recognize as a medical device.
About the enterprise advertisement has "hair growth and dense hair" effect behavior, need to be investigated by the market supervision department, if it is found that the existence of false advertising facts, the enterprise violates the "Chinese people's *** and the State Advertisement Law" Article 28, should be punished according to the provisions of Article 55 of the Advertisement Law; if the false advertising harms the rights and interests of consumers, should be ordered to pay for the advertisement, and should be punished according to the provisions of the Advertisement Law. If the false advertisement harms the rights and interests of consumers, it shall be ordered to make compensation according to the provisions of Article 52 and Article 55 of the Law of the People's Republic of China on the Protection of Consumer Rights and Interests.