We provide services for the registration of medical devices of all classes according to national rules, as well as according to the new rules of the EAEU

Registration of medical devices is a prerequisite for their import, use, sale, and production on the territory of the Russian Federation.

FDA, CE and certificates of other countries are not valid in Russia

Need services for registration of medical devices?

Registration services

Registration of a medical device
Making changes to the registration certificate
Checking of documentation package
Obtaining permission to import of the medical device
Final preparation of the document package

Accompanying tests in the registration process

Toxicological tests
Technological tests
Clinical tests

Companies that trust us

General scheme for registering medical devices in Russia

PREPARATION STAGE

The developer provides technical specifications for a medical device

30 days
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Preparing documents (technical specifications, operating instructions etc.)

60 - 120 days

Technical and toxicological testing of medical devices

Tests for type approval of measuring instruments (if necessary, from 120 days)

STAGE 1
30 days
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Completion and submission of documents for medical device registration to Roszdravnadzor

Working on Roszdravnadzor comments

30 - 50 days

Review of documents

Quality, effectiveness and safety testing according to the submitted documents

Permission for clinical testing

STAGE 2
20 days
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Preparing documents for clinical testing of medical device

30 - 180 days

Clinical testing of medical device

30 - 40 days

Quality, effectiveness and safety testing

Making a decision on state registration or refusal of state registration*

* In case of refusal, the Applicant has the right to apply again for Stage 1. In case of registration of the 1st class medical devices, Stage 1 of registering process is skipped.

At least 230 days are required to obtain a registration certificate in Russia with MEDICA

МD – medical devices

Developer

Laboratory/medical organization

Roszdravnadzor