M
MD_Simy86
Dear all,
I'm looking for a clarification regarding medical device registration in Spain.
I know that in Spain, as a member state of the European Union, medical devices are regulated according to the Medical Device Directive 93/42/EEC.
I have a doubt related to class I medical device:
- Is compulsory or not the registration to the Spanish Databank AMPS?
- Is it required any kind of notification or sending some documents to the competent authority, before starting commercialization of product in Spain?
- Do you know a regulation / guideline of "Ministerio de Sanidad, Servicios Sociales e Igualdad" in which it is written the procedure to register this class of medical devices?
I'm looking for a clarification regarding medical device registration in Spain.
I know that in Spain, as a member state of the European Union, medical devices are regulated according to the Medical Device Directive 93/42/EEC.
I have a doubt related to class I medical device:
- Is compulsory or not the registration to the Spanish Databank AMPS?
- Is it required any kind of notification or sending some documents to the competent authority, before starting commercialization of product in Spain?
- Do you know a regulation / guideline of "Ministerio de Sanidad, Servicios Sociales e Igualdad" in which it is written the procedure to register this class of medical devices?
Thank you in adavance for the help!
Bye bye
Bye bye