The procedure for the import of medical products to Russia with the aim of registration (hereinafter — Import) was adopted by the Order of the Russian Ministry of Healthcare No. 7n dated 15 June, 2012 (hereinafter — Order).
The permit for import of medical products allows the applicant to proceed to a one-time import to Russia of medical products for state registration within six months from the date of permit issue. The delay for granting an import permit or for notifying of refusal of import permit is 5 working days from the submission of the application and the supporting documents. The import permit is granted free of charge.
Documents to submit to Roszdravnadzor to obtain an import permit:
- Application signed by the head of the legal entity (or any other person authorized to act in the name of the legal entity) or by the individual entrepreneur (or their authorized representative), mentioning:
- name of the medical product accompanied with the list of accessories, quantity, works number, serial or lot number, manufacturing date, shelf life and/or working life;
- purpose of the medical products as determined by the manufacturer;
- full and (if applicable) shortened name, form of incorporation of the applicant, their address (location), state legal entity incorporation number or individual entrepreneur registration number, their place of residence, ID details, state registration number of the individual entrepreneur state registration, telephone number and e-mail (if applicable);
- data on organisations where it is planned to have the technical tests, toxicity tests, clinical trials and pattern evaluation of measuring instruments (applicable to medical products classified as measuring instruments by the state regulator for the purpose of standardization of measures; the list of such products is adopted by the Russian Ministry of Healthcare) carried out;
- Copies of agreements for performing the required trials (tests) with the mention of the required quantity of medical products;
- Copy of the document confirming the powers of the authorized representative of the manufacturer.