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Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu
saatja korral palume linke ja faile mitte avada.
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Dears,
I would appreciate it if you could send me the list of documents (or web link with it) needed for the initial submission of the Medical Device Study for CA approval.
Could you please list what is needed for MDR and IVDR studies? As well please provide the Application Form and other local forms that must be submitted only in Estonian.
Could you please confirm that the following price is correct:
„A state fee of 576 euros shall be paid for the review of an application for the permit for a clinical investigation of a medical device, and
27 euros shall be paid for each additional research centre“
Thank you in advance for your response.
Kind regards,
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