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Autocontrol and ‘only once-principle’

Belgium

The Royal Decree of 15 November 2017 regarding the notification of a materiovigilance contact point and the registration of distributors and manufacturers of medical devices concerns the introduction of a new registration procedure that should limit the administrative burden following the ‘only once-principle’. So, the aim is to collect all information that is already known within the authorities (KBO/BCE, VAT databank).

Practical consequences?

  • ABGD/SADN application will be replaced by a new web portal
  • Manufacturers and importers will no longer be encoded by the system as ‘distributor’ but instead according to their exact activity

Additionally, new rules are laid down in this Royal Decree concerning market surveillance of medical devices.

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