Our country will classify and managing the medical equipment

Our country will classify and managing the medical equipment
Our country will classify and managing the medical equipment
Www.xinhuanet.com Beijing 9 Special despatch of the 6th of moon (reporter Chen Fei) The State Council legal system office 6 Japan announces <>Stipulate, the country classifies and managing the medical equipment. The draft stipulates, according to the risk that anticipated purpose, structural characteristic, occupation mode, performance of the medical equipment,etc. may be produced to the human body, divide it into three kinds: It is the first type medical equipment that the risk intensity is lower; A high one of risk intensity is the third type medical equipment, such as plant into the human body or is used for supporting, maintaining the medical equipment of the life etc.; It is the second type medical equipment that the intensity circle of the risk is between the first kind and the third type medical equipment. Among them, the country will put the first type medical equipment on record and managing, will implement registration management to the second kind, the third type medical equipment. The draft stipulates, the first type medical equipment is put on record, does not need to carry on the clinical trial. Apply for the registration of second kind, the third type medical equipment, should carry on the clinical trial, however, it is one of the following situations, can avoid carrying on the clinical trial: Working mechanism is clear, designs finalizing the design, it should be by and there is no serious bad incident record for many yearsing that the production technology is ripe, clinical, do not change regular use; Through non- clinical performance evaluation, can prove its security and validity; Use the data got to analyze and appraise clinically or through the clinical trial to the like product, can prove its security and validity. The draft stipulates, import the first type medical equipment, should be put on record to the national food pharmaceuticals administration department at the same time; Import the second kind, the third type medical equipment, should apply for the registration of products to the national food pharmaceuticals administration department.


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