
The Manufacturers and the distributors working in Portugal are obliged to register the medical devices placed on the market (Article 41. º(DL n º 145/2009 of 17/6) and art 12º (DL n. 189/2000 of 12 /8).
To get in public procurement in particular hospital tenders and for export to third countries (certificates of free sale / movement) it becomes necessary a proof of register of the devices placed on the market, the payment of marketing fees and the proof the device is in process of coding (Despacho 15371/2012).
Yet there are other situations which the economic agents during the course of their activities, are obliged to prove compliance with the requirements either for your business as for your products.
Such evidence shall be issued by the regulatory authority.
We evaluate the need and formalize the request for those certificates such as the payment of marketing fees, the process of recording and coding of devices with the regulatory authority.
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