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Belgium - Medical Devices - International Trade …

    https://www.trade.gov/country-commercial-guides/belgium-medical-devices
    In order to enter the medical equipment market in Belgium, American suppliers should be familiar with the EU directives concerning the registration, marketing, and health/safety standards required throughout Europe as well as regulations specific to Belgium. It is therefore advisable to work with a local … See more

An Overview of Medical Device Regulations in Belgium | RegDesk

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

    Commercialisation of Healthcare in Belgium: Overview

      https://uk.practicallaw.thomsonreuters.com/w-030-7863?contextData=(sc.Default)
      An importer must have a Belgian manufacturing licence to do this ( see Question 3 ). It must also ensure that the imported product has marketing authorisation …

    Medical devices and their accessories | FAMHP

      https://www.famhp.be/en/human_use/health_products/medical_devices_accessories
      Medical devices and active implantable medical devices (AIMD) In vitro diagnostic medical devices (IVD) ) Materiovigilance. Definition; What shall be notify? …

    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 …

    Medical devices | FAMHP

      https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/distribution-export/medical_devices
      Medical devices Medical devices On 07 December 2017, the Royal Decree (RD) concerning the "notification of a materovigilance point of contact and the registration …

    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 Belgium, …

    Regulatory, Pricing and Reimbursement Overview: Belgium

      https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-belgium/
      For drugs and biologicals, the general framework, including in relation to the authorisation, of drugs, biologicals and medical devices can be found in the following laws …

    Medical Device Registration in Belgium - omcmedical.com

      https://omcmedical.com/medical-device-registration-in-belgium/
      Medical Device Registration in Belgium - omcmedical.com Ministry of Health: Federal Public Service, Health, Food Chain Safety and Environment Regulatory Authority: …

    List of Countries without Formal Regulatory Approval …

      https://www.regdesk.co/countries-no-medical-device-regulations/
      Aruba, British Virgin Islands, Cayman Islands, Netherlands Antilles and the Turks and Caicos have no formal medical device regulatory requirements. However, as Overseas Countries and Territories of the EU, …



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