Küsimused

Dear Andrea Battan,

Thank you for contacting us. I notice the e-mail has been sent to [email protected]. Please send future e-mails to [email protected]. As of 1st of January 2025 the regulatory oversight of medical devices in Estonia was tranferred from the Health Board (Terviseamet) to the State Agency of Medicines (Ravimiamet). Mostly the e-mails directed at the old address should reach us but to avoid any loss of communication I recommend making the change.

As for your questions, I will start with the shorter one and answer both with the assumption that you are in the role of a distributor or importer.

For professional use only devices information can be only in English. But it should be noted that the professional user has the right to demand data in Estonian.

As for the question on registration, this does get a little complicated. If you are already supplying samples to the Estonian market then you should notify as the Medical Devices Act § 26 states. If you are not supplying samples and the only reason you ever would supply devices to the Estonain market would be if you won the tender then I would suggest notification after the final decision. This is because, although the offer within the competition might already be seen as making the device available in Estonia, we would prefer to avoid having entries in the database of devices that have actually never been brought into our market. This can’t be completely avoided, as the party buying the devices might specify that a registry entry is a condition to apply for the tender. In that case I suggest starting at the first possible time. It is not uncommon that to have the device registered in our database it might take some corrections in the submitted data and this can cause delays in timelines.

Best regards,

Piret Põiklik
Head of Department

Department of Medical Devices
State Agency of Medicines

[email protected]
+372 5853 3610

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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Hello,

our company would like to apply for some medical devices tenders published in https://riigihanked.riik.ee/

we kind ask how to operate with registration of medical devices:

-registration must be submitted also before of putting in market medical device and already in primary phase when we submit our answer to tender? or it can be done later when is confirmed we have won the tender;

-in some tenders they ask samples of medical devices - in Estonia medical device label and ifu can be accepted to be in English since medical devices we trade are only for professional use in hospitals and clinics?or is mandatory also Estonia language?