As in most countries, in Russia a medical product can be admitted to the domestic market only when and if it has been found in conformity with technical and medical safety regulations pertaining to this particular product.
Assessment of conformity of medical equipment and products to existing safety standards is carried out by the Russian Health Ministry's department called ROSZDRAVNADZOR and Federal State Scientific Certification Center for Medical Products. If found in conformity, the product gets entered in the Federal Registry, and the applicant receives the "Registration" certificate.
Rosstandard handles all interaction with the Russian authorities on behalf of the exporter/manufacturer of medical products, makes sure that the submitted dossiers are complete, and the processing is done without delays.
For medical devices and materials, along with the registration, Russian regulations require a Declaration of TR CU Conformity. Only a legal entity of one of the Customs Union counties can be the applicant for a foreign imported product. It creates a major problem for very many exporters who do not have a representative in Russia, or do not want to to single out one local distributor out of their whole network.
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The documents to be submitted with the application include but are not limited to:
- Letter of the manufacturer;
- Power of Attorney to the authorized agent/consultant;
- Application form;
- Brief description of the medical product;
- Pictures of the product;
- Advertising materials and relevant publications;
- Existing registration documents and licenses;
- Certificate of the medical product as a measurement tool (if applicable);
- Documents certifying the conformity of the medical product to the national or international requirements;
- Risk analysis
- Operational manual
The term of registration is unlimited for medical devices and equipment, and 5 years for medical products
Samples must be shipped officially to your local importer or representative. They will be accepted for testing only if accompanied with due customs documents. A permit from ROSZDRAVNADZOR is necessary to import samples in Russia. To obtain a permit, a number of documents have to be submitted with the application. If all the documents are in good order, the authorities would issue the samples importation permit within 1-2 weeks.
Manufacturer/exporter must inform Russian Federal Authorities of any contingencies that may require amendments in the registration papers.
Russian Health Ministry will renew or amend the Registration license if:
- License has expired;
- Manufacturer's name has changed;
- Another manufacturer is producing it;
- Product's name has changed;
- Product has been upgraded or modernized;
- Application area or usage directions have changed;
- Producer has changed specifications or regulations;
- Changes do not conform to Russian or international standards;
- New materials in the product contact with human body.
Once the Federal Registration has been obtained, you will need to apply for a Customs Union TR CU Declaration of Conformity.
Depending on the product and tests, the overall cost may range from a few thousand to several tens of thousand USD.
The costs comprise:
Consulting fee; Translation and authentication of translation;
Health Ministry Experts fee; Tests and clinical studies; State Registration fee; Russian VAT.
Typically, it takes from 6 to 18 months. In a worst case scenario, it takes forever. We make sure that the processing takes not more than 3 months.
A color presentation is available for download in the PDF format at www.rosstandard.com/medproducts.pdf.