Issue of permission to import medical devices into the territory of the Russian Federation for the purposes of the state registration
Documents received on paper from an applicant / Documents received in electronic form via the electronic system of inter-agency cooperation
To obtain an IMPORT LICENCE for medical devices an applicant submits an application signed by the head of a legal entity (other person having the right to act on behalf of this legal entity) or by an individual entrepreneur (his/her legal representative) to Roszdravnadzor. The application should contain the following information:
1) name of a medical device with indication of component parts, quantity, manufacturing number, serial or batch number, date of manufacture of a medical device, shelf life and (or) operational lifetime;
2) intended use of a medical device as established by the manufacturer;
3) full and abbreviated (if any) name, type of business entity of an applicant, address of applicant’s location, state registration number of a note on creation of a legal entity or an individual entrepreneur, applicant’s residential address, applicants identification document data, state registration number of a note on the state registration of an individual entrepreneur, telephone and e-mail (if any);
4) information about institutions where technical tests, toxicological studies, clinical trials, as well as tests aimed at approval of a type of measuring told (with respect to medical devices referred to measuring tools in government regulation of the uniformity of measurements) will be conducted.
Following should be attached to the application:
1) Copies of contracts for conducting required trials (studies) with identification of a quantity of medical devices;
2) A copy of a document confirming the powers of manufacturer’s authorized representative.
Five working days from the date of the receipt of an application and documents
Free of charge
Organizations for documents submission, business hours, contacts, responsible officers
4, Slavyanskaya Square bld.1, Moscow, 109074.
Monday to Thursday: 9:00 am - 6:00 pm
Friday: 9:00 am – 4:45 pm;
Lunch break: 1:00 pm – 1:45 pm.
Andreeva Olesya – Chief specialist expert.
Tel.: +7 (499) 578-02-68
Mishustin Stanislav – Lead specialist expert, Tel.: +7 (499) 578-02-01