As in most countries, medical product can be admitted to the domestic market in Russia only when and if it has been found in conformity with technical and medical safety regulations pertaining to this particular product. Russia has its own national standards; such as testing which is required for products that already possess CE marking, US Food and Drug Administration 510(k) clearance or other national approvals. Products that have been for sale f.e. on the US and European markets for many years require product testing to Russian standards as well.
Any distribution of medical devices and pharmaceutical products (import, customs clearance, sales, manufacturing, use and maintenance) within the Russian Federation is subject to stringent laws. Any distribution without the appropriate permits from the appropriate governmental authorities is illegal and forbidden.
DENTAL CONSULT Ltd. provides a full range of services associated with obtaining the registration certificate required for the distribution of medical devices within the Russian Federation.
Registration certificate of medical products (medical equipment) is an official document issued by Russian Federal Service for the Supervision of Public Health and Social Development for medical products. Registration Certificate confirms permission to import, sell and use medical products in Russia. According to the Russian legislation all medical products must be registered in Federal Service for the Supervision of Public Health and Social Development.
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All types of consent documents for import/export of medical products
Registration Certificate of medical products (medical equipment) of Federal Service for the Supervision of Public Health and Social Development
Government Registration Certificate of medical products (medical equipment) is an official document which is issued by Russian Federal Service for the Supervision of Public Health and Social Development for medical products (medical equipment). Registration Certificate confirms the permission to import, sell and use medical products in Russia. According to the Russian legislation all medical products must be registered in Federal Service for the Supervision of Public Health and Social Development, have Government Registration Certificate and must be entered in the state register for registration (re-registration) of medical products (medical equipment). According to the technical regulations after the Manufacturer obtains the registration certificate to start import his distributor should obtain Declaration of Conformity.
The documents to be prepared by foreign producers for registration of medical products in the Russian Federation.
List of documents that should be prepared by foreign producers for registration and certification of medical products in Russia (receipt of Registration Certificate by Federal Service for the Supervision of Public Health and Social Development, Obligatory Certificate GOST R and Hygiene Certificate by Federal Agency for Health and Consumer Rights):
В 1. Certificate of incorporation;*Documents are issued by the public agency which registers companies, firms and organizations. To these belong Chamber of Commerce and Industry, Companies house, Administration of Ownership, land courts etc.
2. Documents confirming the production conditions of medical products:*
- Certificate /declaration of conformity of production conditions and quality of the product with the requirements of European directive - РЎР• 93/42 (for chemical agents and analyzers - РЎР• 98/79);
- Certificate of conformity of production conditions with requirements ISO 9001:2000, ISO 13485:2003;
- National certificates of quality management system;
- Other documents.
3. Here are the documents confirming the conformity of medical product with product or specification requirements and standards *:
- Declaration of conformity (for registered medical products with potential risk classes1 and 2 a);
- Certificate of Conformity (for registered medical product with risk classes 2Р±, 3);
- Free Sale Certificate;
- Other documents issued by the agency that controls the distribution of medical products in the market (registration certificate).
4. Letter from a producer which confirms the desire to have the medical product registered and re-registered in the Russian Federation (to make a record that the products were not modified and the technical documentation was not changed)*.
5. Power of Attorney issued to the Russian company in the case the latter carries on registration of products.*
*Note:
The above mentioned documents should be formalized in accordance with the International Law Requirements:
- if the country which files the documents signed the 1961 Hague Convention, abolishing the requirement of legalization for foreign public documents the above mentioned documents should be apostilled:
- if the country which files the documents did not sign the Convention the documents should be legalized by the Russian Embassy;В
- if the country which files the documents has the bilateral Agreement on Legal Aid with Russia the documents are notarized;
В 6. Copies of test reports
7. Maintenance manual should be informative enough for effective and safe operation of the registered product by medical staff in medical institutions for which this product is designed.
As a rule, Maintenance manual consists of the following parts:
- introduction;
- requirements for operating personnel;
- description and operation;
- usage;
- maintenance and repair (working steps in the case of troubleshooting of medical equipmРµnt);
- storage;
- transportation;
- disassembly and utilization;
8. Advertisement leaflets, photos (13x18)