National Registration Portugal
National Registration of Medical Devices with the Portuguese AuthorityMedical Device Manufacturers (or the manufacturer´s representative) situated within the EU but outside of Portugal have to notify the Portuguese Authority INFARMED prior to bringing Medical Devices of risk class IIa, IIb, III or Active Implantable Medical Devices on the market or putting them into service in Portugal for the first time (Chapter IV, article 11,paragraph 3 of Decree no. 145/2009).
Medical Device manufacturers established in non-member countries of the EU are obliged to designate a European Authorized Representative such as MDSS.
Appoint MDSS to perform the Potuguese Registration on your behalfThe registration can be done using the online databank established by the Portuguese Authority; However, the relevant documents shall be provided additionally in electronic form to INFARMED.
For further information please contact:
Medical Device Safety Service GmbH
MDSS Consultancy Division
Phone: +49 511 6262 8630
Fax: +49 511 6262 8633
Or Click here for our Contact Form