16 July 2009 : Obtaining a Free Sales Certificate with Obelis

Published 16 Jul 2009

HOW TO OBTAIN A FREE SALES CERTIFICATE WITH OBELIS

You have two options to utilize Obelis services in order to obtain a Free Sales Certificate:

1. To sign an E.A.R agreement with Obelis and becoming a client (appoint Obelis as your Authorized Representative) and we will take care to obtain the required FSC on your behalf, with the relevant process (*) and with the relevant costs (**).

2. To sign a Legal Mandate ONLY and mandating Obelis to obtain the FSC on your behalf, with the relevant process (*) and with the relevant costs (**) – this solution is applicable to European Manufacturers as well.

(*)The Process for Obtaining a FSC:

A FSC is to be issued by a European Authority ONLY to validate the respective CE certificate of the device by stating that this specific device is “FREE” to circulate in their market and as such it is FREE to circulate in the Non-EU country (e.g. China) requesting the FSC – a Non-EU manufacturer may NOT approach a European Authority Directly, that is the role and duty of his Authorized Representative – he will need to request it on behalf of the Non-EU manufacturer he represents.

As Europe is NOT one country, each member state Authority have their own procedures while many of them do NOT issue FSC anymore – Belgium does! Obelis as a Belgian company has the ability and opportunity to obtain a FSC from the Belgian MOH (Ministry of Health) – in order to do so, Obelis will need to register itself as an exporter of the manufacturer (in addition to the status of an E.A.R or mandatory) and on that basis obtain the FSC while presenting all the essential information as populated on our website

(**) the Related Costs:

1. As an Obelis Client:
Obelis will issue the FSC and have it stamped and validated by the Belgian M.O.H (Ministry of Health – an official European Health Authority) – please contact us to receive an offer
2. As an NON-Obelis Client (with a Legal Mandate):
Obelis will issue the FSC and have it stamped and validated by the Belgian M.O.H (Ministry of Health – an official European Health Authority) – please contact us to receive an offer

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