In the process of registration of medical devices in the Russian Federation there are two difficulties. And we can deal with them:

New development in medical technology is sometimes difficult to bring under the nomenclature classifier of Roszdravnadzor and JECD2. And every controversial situation Roszdravnadzor decides individually. We submit a request to the Office, if we have doubts. It is better to wait a week for a response than to correct documents a month.
Some documents of the registration dossier are not strict. It is convenient to make them, but the department has unexpected questions. We understood this through trial and error, and we receive comments only in particularly difficult cases.
Registration for the EAEU market

The single market of the EAEU medical products implies its own rules for registration of medical devices and medical equipment. It is more complicated, but it will allow you to ship your product to several countries with one registration certificate.

Until the end of 2021, all medical devices in the Russian market must receive a registration certificate of the EAEU sample. It makes sense to immediately register the medical device under the new rules and not to waste time on re-registration.

Select countries of recognition, register medical devices or medical equipment in one of them. And you can deliver the product in all, one RU. You do not need to register the product three times to sell it in Russia, Kazakhstan and Armenia.

Registration according to the rules of the EAEU differs from the national one:

Do not need permission for clinical trials. They are carried out immediately, and the conclusion is included in the dossier.
Check the production. The quality management system at work must meet the standards of the EAEU. To do this, organize a visiting commission.
All documents are consistent in the countries of recognition. Notice of payment of state duty, too.
Technical and operational documentation is translated into the national languages of the countries of recognition.
Since 2022, registration according to the rules of the EAEU will be the only one worth starting now. This is a rewarding experience.

Difficulty is one: legislation continues. Correct accepted documents and publish new ones. For this you need to constantly monitor.

Use our services, you do not have to monitor the legislation of the EAEU, and for us it is part of the work.

Expert support for registration of medical devices

Registration of medical products is a complex of services for the full maintenance of your product.

Check the documentation or develop from scratch
We will write a request to Roszdravravnadzor on all issues
We select laboratories and subtract conclusions
We will work out observations of Roszdravnadzor
We will collect the electronic archive of the current dossier
We ourselves will offer a solution to each problem and report on each stage of work. Do not waste time on the development and correction of documentation - we will do it for you.

We also keep an informational bulletin on the latest developments in legislation, market and science in the field of medical devices.