We provide comprehensive local advice prior market entry as well as full preparation and submission of medical device notifications.
Should you wish to apply for reimbursement of your medical device and if it is eligible for reimbursement we will prepare and submit the necessary documents in the electronic register of medical devices at Bulgarian drug agency in order to obtain reimbursement status for Bulgaria.
As part of this service we also prepare translation and adaptation of your artworks and leaflet text so that it complies with the latest requirements. Of course we can also evaluate your text if you have it handy and advice on its suitability for the local market.And if you have already prepared your own labelling and artworks, we can assess whether they are suitable for the market and its requirements. In case you need an authorized representative for your medical devices in the European area within the meaning of Art. 11 of MDR please contact us.