Kiri

Dear Rita Auglė,

Thank you for your inquiry.

Notification about distribution can be completed through our national medical devices database https://msa.sm.ee/ and is free of charge.

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. 

Documents with the notifications of medical devices are following: Declaration of conformity, EC certificate, instruction for use 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 msa.sm.ee under „Forms“.

Yours sincerely,

Maarika Ojala

Chief Specialist

Department of Medical Devices

+372 5400 4028

[email protected]

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Dear All,

How Could we register in Estonia 

 IIA, IIB, III CLASS AND CUSTOM MADE ACTIVE IMPLANTABLE MEDICAL DEVICE ?

Could You sen us the link,please ?

Sincerely,