Belgium Medical Device Regulations

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, …