Documents for state registration (reregistration) and issue of the registration certificate on the medical devices and medical equipment of foreign production

1)An application

2)A document issued by the producer confirming guarantee and service maintenance of the medical product, the medical equipment

3)The original or a copy of documents certified in the manner established by the law confirming the quality of the medical product, the medical equipment issued in the country of production

4)Protocols andcertificates of sanitary and hygienic testing of medical product, medical equipment taken by accredited laboratories (centers);

5)Protocols andcertificates of clinical trials of medical products, medical equipment taken by accredited health organizations (if available);


6)Instruction on the application of the medical product or the operation manual for the medical equipment;

7)Description of the marking (sample or model), packaging of medical products,