Medical devices refer to instruments, equipment, appliances; their purpose is:
(1) disease diagnosis, prevention, monitoring, treatment, or alleviation;
(2) injury diagnosis, Monitoring, treatment, alleviation, or functional compensation;
(3) inspection, substitution, adjustment, or support of physiological structure or physiological process;
(4) life support or maintenance;
(5) pregnancy control;
(6) The samples are examined to provide information for medical or diagnostic purposes. The state implements classified management of medical devices according to the degree of risk. The first category of medical devices has low risk and implements product filing and production filing management. The second and third categories of medical devices have moderate risks and higher risks and implement product registration, production license management, operation filing, and license management.
There are some tips for purchasing medical device products are as follows:
1. Go to an enterprise with the medical device operating qualifications to purchase.
2. When purchasing, check whether the selected medical device product has a registration approval number or product record number; whether the medical device manufacturer has a production license number or a production record number.
3. Check whether the purchased medical device products have conformity certification documents.
4. Log on to the website of the State Drug Administration to verify the registration (recording) information of the purchased products and the enterprise production license (recording) information.
5. Read the product manual carefully and don't trust the promotion.
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