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Im not sure if this is in the right section. Im trying to understand the spanish medical device market and its very difficult to find information.
I realise that you need to register Class IIa, IIb and III products in their database.
They also seem to have a requirement for an information card per article 33 of their royal decree (1616/2009) - do anyone have experience of this?
Equally for medical devices i don not believe barcoding or sterile packing are required specifically but i was wondering is anyone could tell me if hospital groups or insurance companies demand them?
thanks
I realise that you need to register Class IIa, IIb and III products in their database.
They also seem to have a requirement for an information card per article 33 of their royal decree (1616/2009) - do anyone have experience of this?
Equally for medical devices i don not believe barcoding or sterile packing are required specifically but i was wondering is anyone could tell me if hospital groups or insurance companies demand them?
thanks