Arrangement of import licenses

Permission to import Medical Devicess

Import licenses to medical devices for the purpose of their state registration is a mandatory document for the registration of foreign medical products. It gives the right to a one-time import of a foreign medical device into the territory of Russia. Moreover, only the number of units required for testing can be imported. The permit is valid for 6 months from the date of its issuance. The markings indicated in it, the factory unit numbers and the serial and batch numbers must match those placed on the samples.

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We remind you that the import permit does not replace the State Customs Declaration. GTD must be obtained, because laboratories do not have the right to test samples without this paper.

Documents for import licenses

To get licenses to import a medical device into the territory of the Russian Federation, you need to apply to Roszdravnazor:

Applications from a legal entity that needs to obtain a permit.
Copies of contracts for technical and other tests
A copy of the power of attorney from the manufacturer of the medical device to an authorized person.

An application can only be submitted by an authorized person of a foreign manufacturer. The letter of Roszdravnadzor dated April 3, 2014 No. 01I-444/14 regulated the application form. In the text of the application, you need to specify:

The name and configuration of the medical device, the number of units. For each unit, you will need factory numbers, batch and series numbers, date of manufacture and expiration date or operation.
Purpose specified by the manufacturer
Full and abbreviated name of the applicant’s legal entity, organizational and legal form and all other data. For legal entities — office addresses and contacts, for individuals

Issuance of an import permit

According to the regulations, Roszdravnadzor must issue an import permit within five working days from the date of submission of documents. There is no state fee for this service. You can apply for an import permit electronically through a Single portal. Therefore, the procedure does not take much time.

Grounds for refusal of import permit

The regulations do not provide for reasons for refusing to accept documents for permission to import medical devices, but Roszdravnadzor can refuse to issue the permit itself. There are only three reasons for this:

Not all the necessary documents have been provided, or there is not enough information in the documents.
The import of a medical device is prohibited by an international agreement or a decision of the Government of the Russian Federation.
Roszdravnadzor has information about unaccounted-for risks and side effects detected during monitoring.

In any other case, the agency will allow the import of a medical device for testing and registration