Consultoría regulatoria para importación propia y a terceros,project management y distribución de productos sanitarios  biocidas y cosméticos

 
 

 

 

Authorised Representative / Representante Autorizado en la UE

The directive 93/42/EEC (Medical Devices), makes provision for manufactures to appoint Authorised Representatives.

All authorised representatives appointed by the manufacturers must be established in the EC. The manufacturer may delegate tasks to the authorised representative, setting out the precise duties in writing for which he is delegating his responsability.

The Directive define the authorised representative as having been explicitly designated by the manufacturers to act on his behalf and to have responsability with regards placing the product on the market including dealing with the regulatory authority.

 
+34.984490251 [tlf 1]
+34.984841114 [tlf 2]
+34.984701198 [tlf 3]
Télefono móvil

+34.622 700439

info@eurofarma.es

info@ec-rep.eu
 
 
 

EC-REP

La directiva 94/42/CE obliga a que todo fabricante extracomunitario de productos sanitarios  disponga de un representante autorizado y designado explícitamente por él para que actúe en su lugar y a la que puedan dirigirse las autoridades sanitarias.

Europharma Regulatory Affairs S.L actúa como representante autorizado al ser una empresa especializada radicada en la Unión.

 

FABRICANTE LATINOAMÉRICA

España es la puerta de entrada natural de los productos hispanoamericanos en el mercado europeo: 500 millones de personas.

Fabricantes de productos sanitarios (dispositivos médicos) latinoamericanos, especialmente brasileños, argentinos y chilenos pueden contar con un EC REP español para comercializar sus productos en la Unión Europea.

 
   FAQ
1.The manufacturer remains  responsible for actions carried out by an EC-REP on his behalf.
2.The delegation of tasks from the manufacturer to the EC REP must be explicit and should take place in writing, in particular to define the contents of the tasks and the limits of the representative’s powers. The tasks that may be delegated to the EC-REP according to the directives are of an administrative nature. EC-REP cannot modify the product.
 
 
 
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