The Problems Existing In The Medical Devices In Our Country And Its Countermeasures

Medical devices are special products which are closely related to the health of the public and the safety of life. Medical devices cover a wide range of technology fields and have a wide industry span. Their specialization is very strong. Medical devices also have various categories. Many products contain high scientific and technological content. Some frontier science and technologies, like the gene, Nanotechnology, information, will absorb by Medical devices field and benefit the human beings. Medical devices industry develops rapidly, and Medical devices have more and more effect on human beings' health and play an increasingly important role in the process of people's lives. At the same time, because of biological contamination, biological incompatibility, electromagnetic pollution and other potential hazards. Medical devices' safety and effectiveness have become the focus of the whole society. For Medical devices, which have potential risks to human beings and relate closely to human beings' health, every country has obligatory responsibility to protect the consumers' rights. Although Medical devices industry in our country has developed fast, it is still at its initial stage. The indifference in responsibilities, quantity, law-abiding and credit of Some Medical devices manufacturing enterprises as well as their dishonesty and irregular operations, has intensified the safety lapses of Medical devices production. So it has a profound significance to analyze the problems existing in Medical Devices Administrative Supervision and discuss the effective countermeasures.Based on the collecting of mass data on Medical Devices regulation and summarizing the experience of practice in Medical Devices regulation, the thesis sums up the main problems existing in Medical Devices Administrative Supervision. By analyzing these problems, it will find the deep reasons why they exist. Then put forward countermeasures through comparison with the international mature methods of Medical Devices regulation.The research bases on Medical Devices Administrative Supervision practice of our country, and sums up the problems existing in Medical Devices Administrative Supervision comprehensively and objectively. For example, the insufficiency of regulations, the limitations of supervising personnel's professional skills; insufficiency in technical support; the inconsistence between informatization construction and times; the concept of service needs to strengthening and the regulatory mode needs innovating and so on. Then the thesis analyzes the countermeasure on Medical Devices Administrative Supervision one by one. At last it puts forward six countermeasures by comparison with the international mature methods of Medical Devices regulation, including funding a fair and transparent legislation system; perfecting laws and regulations; increasing capital investment and perfecting infrastructure; improving professional skills and founding a high quality team; increasing technical support t and integrating technical resources; using modern information technology to realize scientific decision and long-term supervision. All of these are for perfecting the regulations and systems of Medical Devices Supervision. They also set a reference for carrying out Medical Devices Administrative Supervision effectively. What's more, they are great helpful for our country founding a scientific, effective and honest Medical Devices Government agencies; realizing Scientific supervision; promoting Medical Devices Profession development; raising the Medical treatment ability of the whole country and the Medical care level of the people.