Medical device registration in the EAEU: points to keep in mind

Whom it may concern, transition period for medical device registration will be over by December, 2021. As a result, companies that are currently undergoing medical registration under the rules of any EAEU member state will be denied registration as EAEU requirements come into force and prevail.

In view of this, it might be a good idea for firms only contemplating import of medical devices to the EAEU, to confirm compliance with new EAEU rules. The rules are stricter but, in the end, with a Medical device registration certificate at hand, you will be able to sell your product across the whole EAEU.

Registration of a medical device involves two stages:

• Document preparation
• Medical device examination and registration

Price and issuing timescale depend on type of the product and its risk class. Here you can find basic information on the document and have a look at its sample: https://ogost.net/medical device registation/

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