The information was published on the portal of the Eurasian Economic Union (EAEU). The new document amends the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices dated December 23, 2014. Especially, this refers to article number 11 touching on the transition period issues, the term of the possibility to get and validity of Russian registration certificates.
What the order is about is clarified below:
- A registration application of medical devices can be submitted according to national registration rules, e.g. Russian, until December 31, 2021.
- Registered according to national rules the medical devices are released to the market in the country executed the registration certificate until the expiration of the certificate validity period. Precisely, Russian registration certificates are valid for the Russian market and they are termless.
- Amending to the necessary information of registered medical devices is able until December 31, 2026.
In the case of fixed-term registration certificates in some EAEU countries, there is a possibility of re-registering medical devices until December 31, 2026 and receive termless approval.
Please, find out more information here.
Manufacturers of medical devices which have termless medical device registration in Russia or in any other EAEU country don’t have to worry about the time being, basically, the order number 28 does not concern their activities. It means the submitted registration certificates are valid and termless. Anyway, there is a possibility that the date of expiry will be established in future by another order.
However, if your new product requires registration is being prepared for market launch, you should start the registration by the end of 2021. In this case, you have the possibility to get Russian national approval. From January 1, 2022, you will have to go through only the EAEU registration rules. Thus, if you are not ready to apply for registration right now, we recommend you to kick on the completing documentation according to the EAEU rules.
Come into operation сhange order to registration period No. 28 is called as “Project” that does not preclude any subsequent improvements of the document.