Import medical equipment in the mass popularity on China's regulatory challenges

Perlong medical equipment nets information: in recent years, our country's medical level has undergone earth-shaking changes, but our country's medical equipment level is not not keep pace, and the domestic many high-end medical equipment all rely on imports, and some small import household medical equipment has been flying into common people's home. The overseas import medical equipment for its high-end sex, advanced and non-substitutability, gradually become public self rehabilitation auxiliary methods and medical institutions of medical level symbol. But with the import of medical equipment related hot degree, our country for such products management regulations are few and far between. The Chinese this medical equipment has the very big relations too look up.

Medical device field and involving multiple disciplines, belong to many kinds of combination and highly sophisticated technology integration, covers almost engineering, chemical, electronic, digital and traditional and modern science and technology of all subjects. For this kind of high-end technology, professional and research institutions have deficits, and what's more, administrative supervision personnel. Therefore, the regulation of existing fear it's okay to be psychological. At present, the function of human body from general used in chemical form, function in the human body way, expected purpose, etc to define the medical equipment. Different form, the way, the purpose of medical devices to diversity, from prevention, diagnosis, treatment, care and ease, compensation, anatomy of physiological processes to research, alternative, and regulate and control of pregnancy, almost involve medical and health service life of the use of all means. And the realization methods of different function use each are not identical, discriminant standard also differ in thousands ways, trying to KuiBanJianBao, with changeless should the possibility is very small.

At present, the special used to adjust the medical equipment production, trading, use the validity of the behavior of the highest regulations issued by the state council is the medical equipment supervision and management regulation "(hereinafter referred to as the regulations) and the regulations formulated according to the administrative rules. And for medical equipment production, use behavior has regulatory role and the "product quality standard". With people from the relevance of speaking, medical equipment supervision should be strict with, and higher than normal product, but from the current "byelaw" the legal effect below "product quality standard" situation, it is difficult to do this.

With the rapid development of the international trade and domestic demand increasing, the import of medical devices and the market share of imports in geometry class growth. At the same time, the development of modern science and technology makes imports more and more high-end medical devices, renewal faster and faster, the Internet sales and modern logistics also broke the traditional sales mode. And the 1990 s make the medical equipment supervision and management regulation "is based on the economic and technology development in the background, it is difficult to adjust the effective involving import medical equipment production, management and use, etc.

Article : From Perlong medical (http://www.pl999.net/)
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