Regulatory roles · Medical devices · Portugal
A Technical Manager for medical device distribution in Portugal
Medical Devices
Decreto-Lei n.º 29/2024, Article 27, provides for the Technical Manager of a medical device distributor in Portugal. If your company distributes or imports medical devices in Portugal, we can take on the role as your outsourced Technical Manager and handle your contact and notifications with INFARMED.
What the role covers and who contracts it
What we do as your Technical Manager
- An appointment agreement that makes us your outsourced Technical Manager.
- Monthly reviews.
- The contact with INFARMED.
- Management of your notifications in SIDM (Sistema de Informação para Dispositivos Médicos).
For which companies. Companies that distribute or import medical devices in Portugal. The role is not for manufacturers; a manufacturer’s device roles are on PRRC and Authorised Representative.
Distribution practice is a separate service. Wholesale distribution of medical devices in Portugal follows the Good Distribution Practice of Portaria n.º 256/2016. We set that up and support it as its own service: the INFARMED activity notification, a review of the technical file for each device, device notification in SIDM, and a quality manual and standard operating procedures (SOPs) for Good Distribution Practice. See Registration and distribution.
Who contracts it. CRITICAL CATALYST - Health Consulting, Lda., Matosinhos, Portugal.
Portugal and the EU
CRITICAL CATALYST - Health Consulting, Lda., Matosinhos
Questions people ask
Is the Technical Manager the same as the cosmetics Responsible Technician?
No. In Portuguese both are called Responsável Técnico, but they are two legal roles under two laws: Decreto-Lei n.º 29/2024, Article 27, for medical device distribution, and Decreto-Lei n.º 189/2008 for cosmetic products. We always say which one. See Responsible Technician (cosmetics, Portugal).
We manufacture medical devices. Is this role for us?
No. The Technical Manager is for companies that distribute or import devices in Portugal. For a manufacturer, see PRRC and Authorised Representative.
Is Good Distribution Practice part of the role?
No, it is a separate service under Portaria n.º 256/2016. A wholesaler can have both from us: the role, and the distribution quality system beside it.
Who deals with INFARMED?
We do, as your Technical Manager: the contact with INFARMED and your notifications in SIDM.
Where this role sits
- Medical-device wholesale distribution complianceThis role: Technical Manager, medical-device distribution (Portugal)
- Step: Registration and distribution
- Related roles: Outsourced QA Director · PRRC and Authorised Representative · all Regulatory roles
- Beside the role: Ongoing support for monthly regulatory support
What happens next
Our team replies to every enquiry and asks what you distribute or import, from whom, and the date you are working to.