Medical device registration for EAEU

Medical devices are products meant for medical use. Hence, everything used for diagnostic, monitoring, treating or preventive purposes is considered medical devices.

Medical devices are to go through a complicated procedure of confirming safety and compliance with existing regulations. Until January, 2022 companies can certify their products according to the national rules of any EAEU member state, for instance, Russia. However, new EAEU regulations are about to come into effect and it is a better idea to confirm compliance with them.

The essence of new EAEU rules for medical devices

Generally speaking, the legislation became much more stringent. For example, under national Russian rules an Applicant was supposed to provide approximately 11 additional documents, along with an application for registration. Under the new rules, however, about 30 additional documents will be requested, from various Test reports to Manufacturer’s plain inspection report.

Naturally, examination of such a number of documents is time-consuming. On average, medical device registration takes 12-14 months requiring additional expenses along the way (state fees, toxicological tests, technical tests).

What’s also important is the risk class of the medical device. Compared to the EU risk classification, the EU classification is less detailed. There are only 4 classes: class III, classes IIa and IIb and class I while in the EU first-class risk devices have a subdivision. Depending on the risk class medical registration can go faster or slower.

In any case, entering the EAEU market of medical devices is fraught with some difficulties but the result will sure open up great business opportunities. You will be able to export products to five EAEU countries: Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan. Registration certificate can have a 5-year or even unlimited validity, if the product has already been on the market for 5 years in three or more EAEU countries.

Medical device registration for EAEU may be a tricky task but with expert guidance it will go without a hitch. Message or call our experts for the latest information concerning registration of your medical devices.

Along with Medical device registration for EAEU, our clients tend to choose:

Medical device registration for EAEU step-by-step

• Document and application preparation, payment of state fees
• Toxicological, technical, clinical testing, submission of the documents to the Federal service
• Product appraisal, production inspection
• Medical device registration

Please note that the steps mentioned might take some time.

Medical device registration for EAEU: authorized representative service

Completing the steps above is only part of the story. To carry out all of that you as a foreign Manufacturer are supposed to have an Authorized representative on the territory of the EAEU. A rep is a company that will speak for you in the EAEU. In case of any problems the rep will field all inquiries from the authorities and if the situation goes bad – be held responsible.

Hence no one’d like to take the blame it might be a challenge to find a company that will represent a medical device Manufacturer. However, there are two options:

•  A Manufacturer convinces their client in the EAEU to represent them
•  A Manufacturer opens a real affiliate company in the EAEU

The first option is the best bet, easy and budget-friendly but keep in mind that some companies might be reluctant to act as an Authorized rep. Contact OpenCert experts and we will help you solve any certification issue. 

A list of CU Technical Regulations:

We work with 30 CU Technical Regulations!

To order Medical device registration we offer you to:

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Reasons to team up with Open Cert:

Lack of necessary permitting documents is fraught with consequences, namely, fines

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