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Competences and role of authorities | FAMHP

    https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/competences_role_authorities
    - Directive 98/79/EEC concerning in vitro diagnostic medical devices. Each Member State designates the competent authority for each directive. The department of medical …

Medical devices and their accessories | FAMHP

    https://www.famhp.be/en/human_use/health_products/medical_devices_accessories
    Legislation. Regulation 2017/745 + 2017/746. CE marking. Presentations. Competences and role of authorities. Clinical investigations and performance studies. …

CAMD - Competent Authorities for Medical Devices : CAMD

    https://www.camd-europe.eu/
    The European Competent Authorities for Medical Devices (CAMD) met for its 51st meeting in Prague on the 20th – 21st October 2022 under the Czech Presidency of the …

National competent authorities (human) | European …

    https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human
    The European Medicines Agency works closely with the national competent …

Belgium Medical Device Registration - FAMHP Approval

    https://arazygroup.com/medical-device-registration-belgium/
    REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities.In Belgium, devices are regulated by the Federal Agency for …

List of Competent Authorities for Medical Devices - AKRN

    https://akrnconsulting.com/list-member-states-competent-authorities-for-medical-devices/
    In the case of medical devices, Article 101 of Regulation (EU) 2017/745 on Medical Devices (MDR) indicates that each Member States shall designate a …

Commercialisation of Healthcare in Belgium: Overview

    https://uk.practicallaw.thomsonreuters.com/w-030-7863?contextData=(sc.Default)
    The relevant Belgian authorities involved in the commercialisation of medicinal products are: The Federal Agency for Medicines and Health Products …

An Overview of Medical Device Regulations …

    https://www.regdesk.co/overview-medical-device-regulations-belgium/
    Learn more about Medical Device regulations in Belgium to comply with the FAMHP, the authoritative body in Belgium, along with the European Union. ...

The Essential List of Regulatory Authorities …

    https://www.raps.org/news-and-articles/news-articles/2020/1/the-essential-list-of-regulatory-authorities-in-eu
    To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website(s) for each country’s ministry of health …

List of national authorities for Medical Devices

    https://easymedicaldevice.com/list-national-authorities-medical-devices/
    Belgium. Federal Agency for Nuclear Control Health Protection Unit Rue Ravenstein 36, 1000 Brussels. ... Cyprus Medical Devices Competent Authority 1 Prodromou & 17 …



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