Legal analysis: medical device, refers to the human body alone or in combination with the use of instruments, equipment, appliances, materials or other items, including the required software; its use on the human body surface and in the body's role is not pharmacological, immunological or metabolic means of obtaining, but there may be these means of participation and play a certain role in assisting; the use of its intended purpose: (a) the (i) the prevention, diagnosis, treatment, monitoring, and mitigation of disease; (ii) the diagnosis, treatment, monitoring, mitigation, and compensation of injury or disability; (iii) the study, substitution, and regulation of anatomical or physiological processes; and (iv) pregnancy control. A substandard medical device is a product that fails to meet medical quality or assurance. Medical device industry is a multidisciplinary cross, knowledge-intensive, capital-intensive high-tech industry with high entry threshold. At present, the overall level of medical equipment in Chinese medical institutions is still very low, in the national primary health care institutions of medical devices and equipment, there are about 15% of the products before and after the 1970s, and 60% of the products before the mid-1980s, and the process of their upgrading and replacement is a process of releasing demand, which will ensure that in the next 10 years or even a longer period of time, China's medical device market The rapid growth of China's medical device market will be guaranteed in the next 10 years or even longer. Although there is a gap between China's medical device industry and that of developed countries, the speed of development of China's medical device industry has impressed the world. Penalties are determined by the scale of production and the consequences of unqualified products, generally a warning and confiscation of illegally produced products and illegal income.
Legal basis: "Supervision and Administration of Medical Devices Regulations"
Article 15, paragraph 1 The production of medical devices, should be in line with national standards for medical devices; there is no national standards, should be in line with the industry standards for medical devices.
Article 37 violation of the provisions of these regulations, the production of medical devices does not meet the national standards for medical devices or industry standards, by the people's government at or above the county level of the drug regulatory department shall be warned and ordered to stop production, confiscation of illegal production of products and illegal income.
"Chinese People's **** and State Product Quality Law" Article 17, paragraph 3 Supervision and sampling of products with serious quality problems, according to the relevant provisions of Chapter V of this Law shall be punished.