Spain's Medical Device Market Specific Requirements

C

cjr978

#1
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
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
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
Hi,

I can't answer your questions, but if I were you I'd try to contact this Sir:

http://elsmar.com/Forums/member.php?u=38185

Cheers,
Ronen.
 
C

cjr978

#3
Hi Ronen,

Thanks for that, i have sent that member a personal message and hopefully he may be able to provide some insight

Chris
 
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