REGISTRATION CERTIFICATE of MEDICAL EQUIPMENT, PRODUCTS of MEDICAL PURPOSE, MEDICAMENTS And NEW MEDICAL TECHNOLOGIES of ROSZDRAVNADZOR (Health Control) of the Ministry of Health and Social Development

In conformity with Russian the legislation, for export of medical equipment, products of medical purpose, medicines and new medical technologies to Russia foreign companies are obliged to obtain Registration certificates of Rospotrebnadzor of the Russian Federation, and also to issue Certificates of Conformity of GOST-R and Sanitary-and-epidemiologic conclusion certificates.
But it is necessary to point out that from the January , the 1st 2007 for the medicines it will be a must to obtain the Declaration of Conformity instead of the Certificate of Conformity and Sanitary-and-Epidemiological Conclusion Certificate. For that purpose forign manufacturers or distributors will have to found a branch or representative office in Russia, registered in accordance with Russian Legislation.

The list of documents necessary for the Registration Certificates of Roszdravnadzor:

1. The letter of the organization-manufacturer.
2. The power of attorney from the organization-manufacturer to the authorized legal person (addressed to its head) for obtaining the registration.
3. The application for registration/re-registration of a medical product.
4. The information about the medical product, containing a brief data concerning its purpose and the basic characteristics (in Russian).
5. A photo (size: not less than 130x180 mm) of a medical product.
6. Advertising illustrative materials (if they are).
7. Documents of registration of the organization-manufacturer in the country of the organization-manufacturer.
8. Documents of registration of a medical product as a measuring device/instrument in the country of the organization-manufacturer and-or other countries.
9. A. Foreign Documents (national or international), testifying that the medical product conform to the requirements of national or international normative documents;
    B. Documents (national or international), describing conditions of its manufacturing.
10. The instruction of the organization-manufacturer for the medical product (in Russian).

The above documents in bold type should be legalized in the country of firm-manufacturer, in other words, they must pass the procedure of assurance of the Russian consulate or to have an apostille. Fullfilling the order NIIC "PromEK" translates the documentation and fills in all the necessary forms of documents!

The terms to obtain the Registration Certificates of Roszdravnadzor:
Medical Equipment and products of medical purpose: 2-3 months;
Medicines and Pharmaceuticals - up to 6 monts;
New Medical Technologies - 2-6 months.