Import permission

Organization of obtaining permits for the import of a test sample, organization of on-site tests on the territory of the Russian Federation and abroad (for foreign-made medical devices)

Application form

Import Permission for Medical Devices in the Russian Federation

In the Russian Federation, the circulation and use of medical devices are regulated by the Federal Law No. 323-FZ of November 21, 2011, “On the Fundamentals of Health Protection of Citizens in the Russian Federation.”

Specifically, Article 38 defines medical devices, categorizes them into classes based on potential application risks, and mandates that all medical devices circulated within Russia (including imports) must be registered in a manner prescribed by the Russian government, thus requiring a Registration Certificate (RC).

Circulating medical devices without an RC can lead to administrative or criminal liability under Article 238.1 of the Criminal Code of the Russian Federation. Penalties may increase further if such unregistered medical devices cause harm to one or more individuals.

An import permission or notification is a vital document for the temporary import of samples for testing and subsequent registration of foreign medical products to obtain an RC.

What is an Import Permission

The procedure for importing medical devices into the Russian Federation for state registration is established by the Order of the Ministry of Health of Russia dated May 2, 2023, No. 201n “On the Approval of the Procedure for the Importation of Medical Devices into the Russian Federation for State Registration” (hereinafter referred to as the Order). This Order is effective from September 1, 2023, until September 1, 2029.

The import permission for a medical device is a one-time authorization, granting the applicant the right to import medical devices into the Russian Federation for state registration. This includes modifications to the documents in the registration dossier that require technical tests, toxicological studies, clinical trials, and tests for type approval of measuring instruments.

Importation of medical devices into the Russian Federation for state registration, including changes to registration documents, is carried out by the manufacturer, the manufacturer’s authorized representative, or the person importing the medical device into the Russian Federation for its state registration (hereinafter referred to as the applicant).

Information Required for Submission to Roszdravnadzor to Obtain Import Permition

Information provided to Roszdravnadzor for obtaining import permission includes:

Notification of the intent to import a medical device, using a personal account in the federal state information system “Unified Portal of State and Municipal Services (Functions),” specifying:

Name of the medical device with indication of the model (if applicable), version (if applicable), equipment of the medical device (if applicable), accessories (if any), quantity, serial number, batch number or lot number (if applicable), date of manufacture of the medical device, its shelf life (if applicable);
Date and number of the registration certificate (for notifications of importing a medical device for changes to the documents of a previously registered medical device).
Intended use of the medical device as established by the manufacturer.
Information about the applicant and the document confirming the authority of the manufacturer’s authorized representative.
Name of the manufacturer of the medical device and the address of its location, address of the place of production of the medical device;
Information about the organizations where technical tests, toxicological studies, clinical trials, and tests for approval of the type of measuring instruments (for medical devices related to measuring instruments in the field of state regulation of ensuring measurement unity) are planned to be conducted, indicating the date and contract number for conducting tests (studies).

Medical Device Import and Field Testing Process

The quantity of imported medical device samples is determined based on the recommendations of testing organizations, considering the device’s risk class and the volume of required tests.

For medical devices that require obtaining permit documentation (e.g., licenses) for testing or installation, conducting major repairs, or building separate capital structures, technical and clinical tests may be conducted by specialists of the testing organization on the manufacturer’s territory or in an organization where the medical device is placed and/or approved for use according to the legislation of that country. For example, field tests are provided for devices such as MRI, CT, X-ray installations, linear accelerators, etc. In all other cases, samples of the medical device must be presented for testing for state registration and must be imported into the Russian Federation in accordance with the law, by obtaining Import Permission.

Our company has extensive experience in conducting field tests and has longstanding direct cooperation with agencies organizing field tests (visa processing, ticket arrangements, and all conditions for staying in the country of departure).

Import permission