Belgian Competent Authority Medical Device

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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

Each Member State designates the competent authority for each directive. The department of medical devices is the competent authority for Belgium concerning directives 90/385/EEC and 93/42/EEC (medical equipment that can be actively implanted and …

Medical devices and their accessories | FAMHP

https://www.famhp.be/en/human_use/health_products/medical_devices_accessories

Medical devices and their accessories. COVID-19. General information; Respirators and ventilators; Surgical masks; Tests; Generalities. Legislation; …

List of Competent Authorities for Medical Devices - AKRN

https://akrnconsulting.com/list-member-states-competent-authorities-for-medical-devices/

The competent authority belongs to the government of the Member State of the European Union (EU) and their responsibility is to transposes the requirements of …

Belgium Medical Device Registration - FAMHP Approval

https://arazygroup.com/medical-device-registration-belgium/

Medical Device Regulations and Classification in Belgium REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In …

SGS Belgium NV Confirmed as a Notified …

https://www.sgs.com/en/news/2021/11/sgs-belgium-nv-confirmed-as-a-notified-body-for-the-new-eu-medical-device-regulation-mdr

We are pleased to confirm that our Belgian Notified Body has been designated by the European Commission and Belgian Competent Authority (FAMHP) …

National competent authorities (human) | European …

https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human

List of national competent authorities in the EEA. Information on coronavirus disease (COVID-19) The European Medicines Agency works closely with the national …

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 …

An Overview of Medical Device Regulations …

https://www.regdesk.co/overview-medical-device-regulations-belgium/

Like the rest of the European Union member states, Belgium separates medical devices into four categories: Class I, Class IIa, Class IIb, and Class III, …

Clinical Investigations Belgium Guideline …

https://www.fagg.be/sites/default/files/Guideline%20Submission%20of%20Clinical%20Investigation%20according%20to%20MDR_version%201.0_2.pdf

All clinical investigations, need to follow a regulatory pathway with the involvement of the Ethics Committee (EC) and/or Belgian competent authority (FAHMP). Depending on …

Everything you need to know about medical devices

https://www.belgium.be/en/news/2019/everything_you_need_know_about_medical_devices

The Federal Agency for Medicines and Health Products (FAMHP) is launching an information campaign to inform healthcare professionals and their …

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