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Medical Device Registration and Approval in Belgium
General country-specific regulatory information is provided on this page for medical device registration and approval in Belgium.
Last updated on November 26th, 2021.
Medical Device Regulations and Classification in Belgium
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Belgium, devices are regulated by the Federal Agency for Medicines and Health Products (FAMHP).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
There are rules for distribution of medical devices in Belgium, On January 2019, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices.
For detailed device-specific compliance information for each market, including Belgium, to expedite the preparation of your medical device or IVD registration application.
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