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LIST OF DOCUMENTS REQUIRED FOR CONSIDERATION OF A QUESTION OF REGISTRATION OF MEDICAL PRODUCTS OF FOREIGN ORIGIN

The list of documents for registration of imported medical products
a) a copy of the document confirming the authority of the authorized representative of the manufacturer;
b) information about regulatory documentation for the medical device;
c) technical documentation of the manufacturer for the medical device;
d) operational documentation of the manufacturer for the medical device, including application data sheet and operating instructions of the medical device;
e) photographic image of the visual appearance of the medical device with the accessories necessary for the intended application of the medical device (at least 18 x 24 centimeters of size);
f) documents confirming the results of technical tests of medical products;
g) documents confirming the results of toxicological tests of medical products, the use of which requires a contact with the human body;
h) documents that verify the test results of the medical device in order to confirm the type of measuring equipment (concerning medical devices related to measuring equipment in the sphere of government regulation of providing the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);
i) list of documents;
j) information supporting clinical efficacy and safety of medical devices (if available);
k) a draft plan of clinical testing of the medical device with necessary materials that substantiate this draft plan(if available).