Medical device registration in the Russian Federation
Medical device GOST certification in the Russian Federation  

     One of the important directions of activity Farm-Invest ZAO is to provide services in preparation, organization and support process of registration of medical equipment and medical devices of national and foreign production, as well as support procedure for obtaining Registration Certificate, Certificates of Conformity (GOST) and sanitary-epidemiological conclusion.

    Draw your attention to the fact that:

• Medical device regulation requires that medical devices / medical equipment must be tested in granting approval. Tests should be made in Russia.
• Foreign medical devices / medical equipment must conform to Russian standards which are not the same as European or International standards.
• Certificates which devices already has been given will only help you and us coordinate the process of registration and certification in Russian.

     Medical devices and medical equipment can’t be sold without Registration Certificates and GOST on the territory of Russian Federation. Both certificates are required for foreign medical devices or they will be stopped upon by Russian Customs.

    We will assist in preparing the necessary documentation, prepare registration file according to Russian regulations, organization of technical, toxicological, clinical (medical) and other tests.

    We always will be pleased to respond to all your questions and consult you.

    LIST of documents for registration important devices

Item	Name of the document	Requirements
1.	Application	""Submitted in hardcopy (3 copies) and in electronic format by the applicant – by all means a Russian company (applicant), which will be presented in the Registration Certificate as the recipient of said Registration Certificate
2.	Table of analogs (as an annex to the Application and Regulatory Document) – if necessary	Has a set form. If necessary is submitted together with the Application and Regulatory Document
3.	Power of attorney for the Applicant from the manufacturer	Submitted by the manufacturer (has a set form, ApostilleM is a must)
4.	Document of the manufacturer registration as legal entity	Submitted by the manufacturer – Apostille is a must
5.	Certificate for the production quality control system ISO 13485 ISO 9001	Submitted by the manufacturer – Apostille is a must
6.	Product Certificate:     1. СЕ certificate.     2. Registration at national Min. of Health     3. Certificate of conformance to requirements of MDD 93/42/ЕЕС.     4. Declaration of conformity, etc.     5. FREE SALE CERTIFICATE     6. FDA	Submitted by the manufacturer – Apostille is a must (for products of safety class 1 and 2а a declaration of conformance may be enough, for 2b and 3 – a certificate issued by a third party may be necessary, i.e. TUV, or local Ministry of Health etc.)
7.	Instruction on application/operating manual	In Russian, first copy is a hardcopy, second one – in an electronic format;
8.	Illustrated advertising material
9.	In case of re-registration – a copy of the Registration Certificate	Applicant company head’s signature and seal on each page, otherwise – notarization
ADDITIONAL INFORMATION necessary for testing
1.	class of risk
2.	Set of operation documents (description with specifications, operating manual (in Russian and in English (German), Certificate)