Should foreign manufacturer have sales partner to start market access process?

Should foreign manufacturer have sales partner to start market access process?

There is no need to establish a sales partner. Let us go deeper into the history of this topic:

  • Before 2013, different rules for marketing authorisation of a medical device were in effect, and according to them the MAC holder had a full title and other rights in this certificate. Often the MAC holder was in fact a dealer (the manufacturer’s partner responsible for sales in the RF), which was a significant benefit, since this practice ensured exclusive profits on sales, making other dealers unable to use the MAC in question. Moreover, often the dealer was paying MAC-associated fees and costs because of those future benefits.
  • As per actual regulations, all titles and rights to the MAC are with the manufacturer, therefore, sales partners are not interested in participation in the MAC process, nor will they pay for it any more.

The Authorised Representative of the manufacturer in the RF is therefore required for marketing authorisation.

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