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News and Views March 2017

New Medical Device Regulation (MDR) in Europe
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8. Medical Device Networking Meeting
Hanover, April 27, 2017




Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

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contact us





MDSS National Registration Services

 National Registration of Medical Devices with the Portuguese Authority

Medical 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.

Appoint MDSS to perform the  Potuguese Registration on your behalf

The 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
Schiffgraben 41
30175 Hannover
Germany

Phone: +49 511 6262 8630
Fax: +49 511 6262 8633

Or Click here for our Contact Form

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