Medical devices Belgium (FAGG)

Medical devices Belgium (FAGG)

Do you want to offer medical devices via bol on the Belgian market? Then ensure you apply for sales rights by following the steps below. A medical device is a health item that, by its function, differs from a medicine. The function of a medical device is physical – think, for example, of a plaster, a prosthesis, a scanner, or an external defibrillator.

Guidelines in Belgium

In Belgium, the government institution FAGG is responsible for guaranteeing the quality, safety, and effectiveness of medicines and health items, including medical devices. Depending on an organization's activity, registration in the FAGG web portal may or may not be required. To offer medical devices via bol to Belgian customers, you must demonstrate that you are registered with FAGG as a distributor, or that you are a manufacturer or importer.

Distributors of medical devices must always register with FAGG. Manufacturers or importers do not have to, as they cannot be considered distributors for the same device or devices.

Applying for sales rights for medical devices in Belgium

1. Registering with FAGG

Send the information below (depending on your choice) as an application for sales rights to healthassortment@bol.com;

• seller account name
• Chamber of Commerce number
• VAT number
• (bol) Retailer ID
• seller email address
• FAGG registration number or email with a confirmation from FAGG of your status
  • Distributor: If your company is a distributor, registration must be done via the FAGG web portal.
  • Manufacturer/importer and other: If you are not a distributor, have questions about registration, or want confirmation of your status as a manufacturer/importer, you can contact FAGG via: notifications.meddev@fagg.be.

2. We will check if you meet the requirements, and you will be informed of the outcome of your application by email.

• Distributor: your registration must be visible in the public FAGG portal. There you will also find your unique FAGG number.
• Manufacturer/importer: your registration must be visible in the public EUDAMED portal. There you will find your unique Actor ID or Single Registration Number (SRN).

Once you have received sales rights, you may offer medical devices in Belgium. Sales rights are checked periodically. Ensure that your product range and FAGG registration are in order at all times.