National Registration of In-Vitro Diagnostic Devices and Medical Devices with the Spanish Authority
Any physical or legal entity has to notify the Spanish Authority "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" prior to bringing Medical Devices of risk class IIa, IIb or III on the Spanish market or putting them into service in Spain for the first time (chapter 6, article 22, Royal Decree (RD) 1591/2009).
In-Vitro Diagnostic Device and Medical Device manufacturers who are located outside the EU are obliged to designate an Authorized Representative (article 24, RD 1591/2009).
The Spanish national registration will be done electronically, by the Authorized Representative, via an online databank established by the Spanish Authority.
Appoint MDSS to perform the Spanish National Registration on your behalf
Our service includes:
- Advice regarding the data requirements and review of the required technical documentation of Medical Devices and In-Vitro Diagnostic Devices
- Multilingual staff with profound regulatory experience
- Insertion of the relevant Medical Device and In-Vitro Diagnostic Device product information into the online database of the Spanish Authority
- Communication in Spanish Language with the Competent Authority
For further information please contact us:
Medical Device Safety Service GmbH
Phone: +49 511 6262 8630
Fax: +49 511 62628630
Or Click here for our Contact Form
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