Peru Medical Device Registration License Transfer

J

jinglot

#1
Hi! We have medical device registration in Peru and our current distributor's name is on it. We are now looking to change distributors. I am having a tough time finding requirements for license transfer in Peru. Has anyone done this? Do we need to do a new registration with the new distributor or can we just transfer the license?

Any help is appreciated! Thank you in advance!
 
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Marcelo

Inactive Registered Visitor
#2
It?s always difficult to understand Peruvian law because new laws keep changing older ones almost ad infinitum :p

I think the main requirement for transfer is in the following document : DECRETO SUPREMO N? 020-2001-SA (which changes Decreto Supremo N? 010-97-SA) -
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/DECRETOSUPREMON020-2001-SA.pdf

Art?culo 23?.- El Registro Sanitario otorgado a un producto s?lo podr? ser transferido por su titular a favor de persona distinta, siempre que esta ?ltima cumpla con lo dispuesto en el Art?culo 6? del presente Reglamento. En tal caso deber? presentar copia legalizada o fedateada del documento que acredite la transferencia."

Art?culo 6? is from Decreto Supremo N? 010-97-SA - http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/DECRETOSUPREMON010-97-SA.pdf

Art?culo 6.- Podr?n solicitar Registro Sanitario quienes est?n debidamente constituidos en el pa?s como laboratorio farmac?utico, empresa fabricante, droguer?a o importadora y que hayan comunicado el inicio de sus actividades a la DIGEMID.

The procedure for transfer is in http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/EPFarma/TUPA_CAM_OTR.pdf, item 108.

And the form used is here http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/ERDisMed/Formatos/Formato_Transparencia.pdf
 

tibon74

Involved In Discussions
#7
Hi !
Who is the owner of the registration in Peru ? the foreign manufacturer or the local representative?
Is it possible the authorized representative without its agreement?
thank you !
 
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