On-line Registration for MD/IVD by its Manufacturers/Authorized Representatives (FABDM)

Imprimir


Inserted in the plan to reform the IT architecture for information management of products regulated by INFARMED, IP, and together with the implementation of a repository of information on medical devices, was understood to be necessary to provide the process for registration of medical devices by its manufacturer/ authorized representative of a support that allows computerized on-line notification of medical devices and the computerized management of the entire process.

Thus, the new registration system for Medical Device Manufacturers / Authorized representatives, aims to replace the previous registration procedures (some of which have been carried out not in electronic format, "on paper").

Under the new system were implemented a set of processes and features that are based on the activities inherent to the process of registration of DM / DIV by their Manufacturers / Authorized representatives addressing the legal requirements set out in European Directives and national legislation.

According to the European Directives applicable to medical devices and medical devices for in vitro diagnostic a manufacturer is defined as ¿the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.¿

When the manufacturer is not established in the European Community should establish a contract with an entity based in Europe, which will act and will be addressed by the Community authorities and bodies, on behalf of the manufacturer, as regards his obligations in accordance with applicable law. This entity will be considered the manufacturer¿s authorized representative. To a medical device manufactured by the same manufacturer can only be associated one authorized representative. 

As part of market surveillance is essential to know the devices and those responsible for placing on the market so, the following requirements for registration / notification of medical devices for manufacturers or their representatives are established:

  • Registration of Class I Medical Device by national manufacturers:
  • The national manufacturer of class I medical devices or his authorized representative based in Portugal shall notify the INFARMED, IP, as set out in paragraph 1 of Article 11, Decree-Law No. 145/2009 of 17 June.
  • Registration of Custom Made Medical Device by national manufacturers:
  • The national manufacturer of custom made medical devices or his authorized representative based in Portugal shall notify the INFARMED, IP, as set out in paragraph 1 of Article 11, Decree-Law No. 145/2009 of 17 June.
  • Registration of systems or procedure packs by national manufacturers (assemblers):
  • The national manufacturer of systems and procedure packs or his authorized representative based in Portugal shall notify the INFARMED, IP, as set out in Article 10, Decree-Law No. 145/2009 of 17 June.
  • Registration of class IIa, IIb, III and implantable active medical devices by national and non national manufacturers: 
  • The manufacturer of class IIa, IIb, III and implantable active medical devices or his authorized representative which put in service medical devices in Portugal shall notify the INFARMED, IP, as set out in paragraph 3 of Article 11, Decree-Law No. 145/2009 of 17 June.
  • Registration of in vitro diagnostic medical devices by national manufacturers: 
  • The national manufacturer of in vitro diagnostic medical devices or his authorized representative based in Portugal shall notify the INFARMED, IP, as set out in paragraph 1 and 2 of Article 10, Decree-Law No. 189/2000 of 12 August.
  • Registration of in vitro diagnostic medical devices by non national manufacturers:
  • The non-national manufacturer of in vitro diagnostic medical devices or his authorized representative shall notify the INFARMED, IP, of Annex II and self-testing in vitro diagnostic medical devices as set out in paragraph 3 Article 10, Decree-Law No. 189/2000 of 12 August.

For all these notifications, data and documentation to be submitted to INFARMED, IP are required in obligatory way in the system.

On-line Registration for MD/IVD by its Manufacturers/Authorized Representatives (FABDM) 
(updated in 19-01-2012)

Short User Manual