Kiri

Dear Miks,

Thank you for your inquiry.

The distribution notification can be done through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact person’s full name, e-mail and the position in the company. 

Therefore, does the account go to your name?

Documents with the notifications of medical devices are following: Declaration of conformity, EC certificate, instruction for use in English, instruction for use in Estonian and copy of the labelling or packaging.

Also, please use a short guide for using the Estonian Medical Device Database that can be found on database homepage under „Forms“.

NB! Please note that the access to the database is limited to users outside of Estonia.

In case of this, please contact with abi@tehik.ee with an request to access to the database and your IP address. They will white-list your IP and you should have an access to the database.

This is a temporary restriction for security reasons which hopefully will be removed in near future.

Please do not hesitate to contact me for further information or any questions.

Kind regards

Jaak Raud

Chief Specialist

Department of Medical Devices

+372 5561 0969

jaak.raud@terviseamet.ee

Republic of Estonia

Health Board

+372 794 3500

info@terviseamet.ee

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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