In recent years, imported medical devices have entered the medical field and the ordinary people's homes at an increasing speed. Due to their high-end, advanced and irreplaceable, they have gradually become a symbol of the public's self-healing and even the medical level of medical institutions. What is not appropriate is that the relevant regulatory work has not been followed up. Apart from the influence of some external factors, the most important reason is the supervisor's look up on the subject of supervision.
Supervision is not easy
As a result of the property, medical device supervision is not easy, and the supervision of imported medical devices is particularly difficult.
Medical devices cover a wide range of fields and disciplines. They are a subtle combination of highly diverse technologies and highly integrated, covering almost all disciplines of engineering and chemistry, electronics, digital and other traditional and modern technologies. For this high-end technology, professionals and research institutions are still far behind, not to mention administrative supervisors. Therefore, it is normal to have timidity in its supervision.
At present, medical devices are generally defined in terms of functional physicochemical forms for the human body, ways of acting on the human body, and intended purposes. Different forms, methods, and purposes determine the diversity of medical devices, from prevention, diagnosis, treatment, monitoring, mitigation, compensation, dissection to research, replacement, regulation, and pregnancy control of physiological processes, involving almost all medical and service life and health. The use of all means. The implementation of different functional uses is different, and the criteria for judging are also very different. It is very unlikely to try to see the leopard and change it.
In addition, medical devices have the duality of both medical and civilian use. The function of the medical device is partly realized by the medical technicians of the medical institution through medical activities, and the other part is self-realized by the patient according to the function of the medical device, or assisted by the help of others. Some medical devices are clearly used by both doctors and civilians, and some are used by both doctors and civilians. If the regulator can still put the medical devices of the operating and using units into the regulatory field of vision, it is difficult to balance the non-disposable and consumed medical devices that the patients purchase for their own use.
Lack of law and regulations and lag
Can existing laws and regulations support the supervision of medical devices, especially imported medical devices?
At present, the most effective regulations specifically for adjusting the production, operation and use of medical devices are the Regulations on the Supervision and Administration of Medical Devices promulgated by the State Council (hereinafter referred to as the “Regulationsâ€) and the departmental regulations formulated in accordance with the Regulations. The Product Quality Law is also used to adjust the production and use of medical devices. In terms of relevance to human beings, the supervision of medical devices should be stricter and higher than the general products, but it is still difficult to achieve this from the current legal status of the Regulations is lower than the current status of the Product Quality Law.
So far, there is no law, regulation or regulation specifically for importing medical devices, which is incompatible with the current import volume, technical content, usage and regulatory requirements of imported medical devices. In addition, the existing laws, regulations and regulations lack the operational provisions for regulating the importation, sale, use, inspection and maintenance, and disposal of imported medical devices.
With the rapid development of international trade and increasing domestic demand, the import volume and market share of imported medical devices have grown geometrically. At the same time, the development of modern science and technology has made imported medical devices more and more high-end, and the speed of renewal has become faster and faster. Internet sales and modern logistics have also broken the traditional sales model. The "Regulations on the Supervision and Administration of Medical Devices" formulated in the 1990s was based on the economic and technological development of the time. It is difficult to effectively adjust the current production, operation and use of imported medical devices.
"Three less" phenomenon seeking cause
The phenomenon of “three less†in the supervision of imported medical devices, which has fewer active checks, fewer problems, and fewer penalties, can be attributed to the true performance of the regulators.
One is the fear of intertwining and discouragement. On the one hand, it is thought that imports must be better than domestic ones. The so-called high-tech products must be of high quality and legal compliance. On the other hand, the fear of foreign products leads to fear of regulatory psychology, and it is not as good as it can be managed. Regardless of. As a result, it is not difficult to understand that supervision is stopped at importing medical devices.
Second, the variety is complex and difficult to distinguish. The medical device system is complex. There are only 42 systems in the Catalogue of Medical Devices published by the State Food and Drug Administration, and each system has several categories, subjects, varieties, and specifications. Each model is divided into different categories, and different categories have different regulatory requirements. Therefore, it is really difficult to make legal and illegal analysis and judgment in order to identify the mechanical and non-mechanical, mechanical and pharmaceutical, imported and domestically produced, and determine the management category of medical devices in the first time and on the first site.
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