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Regulatory controls for medical devices | Government …

    https://www.terviseamet.ee/en/medical-devices/regulatory-controls
    At the present time there is no NB for medical devices in Estonia. A medical device placed on the market or put into use in the European Union is allowed to be sold in Estonia, although there is a requirement for notification if the device is in Class IIa, IIb, III or AIMD (§ 26 of Medical Device Act); the notification of Class I devic… See more

Legislative framework for medical devices | Government …

    https://www.terviseamet.ee/en/medical-devices/legislative-framework
    Regulations are legal acts that apply automatically and uniformly to all EU countries as soon as they enter into force, without needing to be transposed into national law. They are …

Medical devices | Government installation profile

    https://www.terviseamet.ee/en/medical-devices
    Medical devices | Government installation profile Home Medical devices Medical devices Terviseamet/Health Board is a Competent Authority in the field of medical devices in …

Medical Devices Act–Riigi Teataja

    https://www.riigiteataja.ee/en/eli/ee/509012015001/consolide/current
    (1) This Act regulates the placing on the market, putting into service, making available on the market and distribution, clinical investigations and performance studies, …

Medical Devices Act–Riigi Teataja

    https://www.riigiteataja.ee/en/eli/528052020008/consolide
    (1) An in vitro diagnostic medical device shall be placed on the market and put into service only if the device meets the requirements of this Act and legislation …

Labelling and language requirements for medical devices

    https://www.terviseamet.ee/en/labelling-and-language-requirements-medicaldevices
    If the device is meant for lay user, everything accompanying the device shall be in Estonian (package and instructions for use). For software: User interface in English is acceptable …

Estonia Medical Device Registration - HPI Approval

    https://arazygroup.com/medical-device-registration-estonia/
    In Estonia, devices are regulated by the Estonian Health Board Terviseamet. CLASSIFICATION SYSTEM: Medical devices are classified according to …

The Lowdown on Medical Device Regulations in Estonia

    https://www.regdesk.co/the-lowdown-on-medical-device-regulations-in-estonia/
    Medical devices in Estonia are regulated by the Estonian Health Board, or Terviseamet in Estonian. Before 2010, both medical devices and pharmaceuticals were controlled by the State Agency of …

Medical Device Registration in Estonia - omcmedical.com

    https://omcmedical.com/medical-device-registration-in-estonia/
    Medical device registration in Estonia is carried out according to general and simplified procedures. The approval for medical equipment and medical methods …

PharmaBoardroom - Regulatory, Pricing and …

    https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-estonia/
    On national level, Medical Devices Act (MDA) and regulations thereof are applicable in extent not regulated in EU regulations. Pricing of medical devices is not …



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