The list of the documents submitted to the Federal Board For Public Health Services and Social Development Supervision for registering products used for medical purposes

1. List of submitted documents - in 2 copies;
2. Application for registering the products used for medical purposes - in 2 copies ¹;
3. The document which confirms the payment of the state tax (in the cases provided by the Russian legislation);
4. Certificate (or reference) for a product used for medical purposes *;
5. The documents which confirm the manufacturer registration as of legal entity: an extract from the Uniform State Register of legal entities (ЕГРЮЛ), an extract from the Company Register, which shall be issued by an authorized body in the country where the manufacturer is registered *;
6. Power of Attorney or an authenticated copy of the contract (in the case when the applicant is not the manufacturer of a product used for medical purposes), the above documents shall specify the authorities of the applicant (including the execution of Registration Certificate on the applicant’s name) *;
7. The documents which confirm the conformity of medical product manufacturing conditions with the requirements of the legislation of Russian Federation and the international specifications*: Qualification Tests Certificate and/or License for manufacturing medical equipment, Certificate/Declaration* of conformity of manufacturing conditions and the quality of production with the requirements of European guideline СЕ 93/42 (for reagents and analyzers SE 98/79), Certificate/of conformity of product manufacturing conditions with the requirements of ISO 9001:2000 standard and/or ISO 13485:2003;
8. A draft of the standard document ¹ together with the documents which confirm the conformity of a product used for medical purposes with either the requirements, or the specifications, or standards (test records required for this kind of products: acceptance technical tests (for electrical devices the EMS report is needed), toxicological tests, medical tests (minimum 2х reports from various medical institutions);
9. Operation Manual for a product used for medical purposes ¹;
10. A draft manual for a medical application when registering the physiotherapeutic devices and reagents (sets) for diagnostics (in vitro), which is supposed to be independently used by the end user ¹, and which shall be approved by the head of the establishment which conducted the medical tests.