The import of medical products for the purpose of state registration is defined by the regulation of the health department of the Russian Federation no. 7 of June 15, 2012.
For importing medical devices in the Russian Federation, authorization has to be obtained in advance. The approval is granted by the Federal Authority of health control Roszdravnadzor. The authorization is valid until 6 months after the date of issue.
The following documentations are required to apply for an import license:
- Application with following indications:
- product specification with components, quantity, manufacturing number, serial number, manufacturing date, lifetime
- scope of application of the medical products
- name of the manufacturer, address, legal form, registry number
- name and address of the testing laboratory
- Copy of the contract with the testing laboratory, that will conduct the tests
- Authorization of the representative
All documents have to be presented in Russian. Documentations in German or English have to be translated. The translation has to be certified by a notary.
Schmidt & Schmidt supports you importing medical products and their following state registration. Please send us a request for further details about the procedure and the prices.