Custom-Made Medical Device Regulations and Registration in Argentina

[mandu]

Dear All
Can someone help me to have information about register a Custom-made medical device in Argentina?
Is there a particular procedure as in Europe or does it exist a specific product code and classification as in USA?
The medical device in question is a custom skull implant and your help would be really appreciated.
: I hope that someone can help me....

 

[Stijloor]

Re: Custom-Made Medical Device Regulationa and Registration in Argentina

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Ajit Basrur]

Re: Custom-Made Medical Device Regulationa and Registration in Argentina

Dear All
Can someone help me to have information about register a Custom-made medical device in Argentina?
Is there a particular procedure as in Europe or does it exist a specific product code and classification as in USA?
The medical device in question is a custom skull implant and your help would be really appreciated.
: I hope that someone can help me....

For registering a medical device, pls check at ANMAT (equivalent to FDA) here - http://www.anmat.gov.ar/webanmat/normativas_productosMedicos_en.asp

They could be contacted at -

Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800 / 54-11-5252-8200

 

[Rocke]

Argentina:
Does anybody have a link to ANMATs the "Registro Nacional de Productores y. Productos de Tecnolog?a M?dica (R.P.P.T.M.)" - I cannot find it and I need to look up a specific registration number??

Best regards
Camilla

 

[Ajit Basrur]

Argentina:
Does anybody have a link to ANMATs the "Registro Nacional de Productores y. Productos de Tecnolog?a M?dica (R.P.P.T.M.)" - I cannot find it and I need to look up a specific registration number??

Best regards
Camilla

Hi Camilla,

Are you looking for this - http://www.anmat.gov.ar/boletin_anmat/BOindex.asp ?

 

[Rocke]

Thanks a bunch - it's amazing how someone in here always knows.

/C