regulations.

in order to ensure the safety and effectiveness of medical instruments, safeguarding human health and life safety, regulations stipulated in terms of dealing with medical device registration of medical equipment products and for the record, medical equipment production, Cheap Titans Jerseys medical device operation and use, adverse events recall, supervision and inspection.

regulations make clear, the national medical instrument according to the degree of risk management. The first is the risk degree is low, the conventional management can ensure safe, effective medical instrument; the second category is moderate risk, the need for strict control of management in order to ensure safe, effective medical instruments; third is a high risk, the need to take Cheap Cowboys Jerseys special measures to strictly control the management in order to ensure safe, effective medical instrument.

Classification rules of

state food and drug supervision and administration department is responsible for the development of medical equipment and classified catalogue, and according to the medical device production, management, use, timely medical risk analysis, evaluation, adjustment to the catalogue. Cheap Steelers Jerseys

byelaw points out, the development of medical devices shall abide by the principles of safety, efficiency and saving principle. The State encourages research and innovation of medical equipment, play the role of the market mechanism, promote the popularization and application of new technologies to promote the development of medical equipment, medical equipment industry. Medical devices shall comply with the mandatory national standard of medical devices; there is no mandatory national standards for medical devices, shall comply with the mandatory industry standards. Disposable medical device directory by the food and drug supervision and Administration Department of the State Council health health departments Cheap Bengals Jerseys formulate, adjust and publish.

The provisions of the law responsibility for illegal production, management, use of medical devices and illegal conduct medical device clinical trials, the publication of false medical advertising behavior of

regulations.

has one of the following three cases, namely, production, management has not obtained the registration certificate of medical devices second, third types of medical equipment; unauthorized engaged in second types, third types of medical equipment production activities; unauthorized engaged in third types of medical equipment management, regulations, by the county level above people's Cheap Texans Jerseys State Food and drug supervision and administration department shall confiscate the illegal income, illegal production and management of medical equipment and used for the illegal production and management tools, equipment, raw materials and other articles; lack of illegal production and operation of the medical value of the amount of 10000 yuan, and impose a fine of 50000 yuan and 100000 yuan; value the amount of 10000 yuan, and the value of the amount of 10 more than 20 times the fine; if the circumstances are serious, the medical licensing relevant responsible person and enterprise applications will not be accepted within 5 years.

regulations also stipulate, in violation of the present regulations, which constitutes a crime, shall be investigated for criminal responsibility according to law; cause person, property or other damages, it shall bear liability for compensation.