Falsified medical devices: how can distributors protect themselves?

Falsified medical devices: how can distributors protect themselves?

PhaRegistrum · Originally published on 26/03/2026

During inspections, INFARMED, I.P. sometimes identifies falsified medical devices circulating in the Portuguese market.

To prevent risks, distributors should ensure:

  • All devices are registered with INFARMED, with approved packaging and leaflets.
  • Each device has an associated reference visible on its packaging.
  • The public InfoDM platform is used to validate approved devices and official references.
  • A robust Quality Management System is in place, aligned with Portuguese Order No. 256/2016.

PhaRegistrum helps distributors implement good practices and mechanisms to detect falsified products.

#PhaRegistrum
#DispositivosMédicos
#Falsificados
#Infarmed
#Distribuição
#Qualidade
#Compliance

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