Medical devices

Import licence for medical devices allows an applicant to perform a one-time import of medical devices into the territory of the Russian Federation for the purposes of the state registration within six months from the date of issue thereof.

The Import licence or rejection notification shall be issued within 5 working days from the date of the receipt of an application and other documents. The service is provided free of charge.

Documents required by Roszdravnadzor to obtain the Import licence:

1. Application signed by the head of a legal entity (or other person having the right to act on behalf of this legal entity)or by an individual entrepreneur (his/her legal representative) and containing the following information:

• 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;

• Inteded use of a medical device as established by a manufacturer;

• full and abbreviated (if any) name, type of incorporation of a legal 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,  applicant’s identification document data, state registration number of a note on the state registration of an individual entrepreneur, telephone and (if any) e-mail;

• information about institutions in which it is planned to conduct technical tests, toxicological studies, clinical trials, as well as tests aimed at approval of a type of measuring tools (with  respect to medical devices referred to measuring tools in the field of government regulation of the uniformity of measurements);

2. Copies of contracts for conducting required trials (studies) with identification of a quantity of medical devices;

3. A copy of a document confirming the powers of manufacturer’s authorized representative.

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.

Timeframe

Five working days from the date of the receipt of an application and documents

State duty

Free of charge

Organizations for documents submission, business hours, contacts, responsible officers

Mailing address:

4, Slavyanskaya  Square bld.1, Moscow, 109012.

Business hours:

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

e-mail: meddevices@roszdravnadzor.ru