S.L. 458.59 Art. 5Importation, wholesaling, manufacturing or re-purposing of medicinal devices. 3

(1) No person shall carry out importation, wholesaling, manufacturing or re-purposing in Malta of any medical device which is intended for trade within the European Union and, or the local market prior to obtaining all the necessary approvals, authorisations, licences, permits and, or any notification/s as required by or under these regulations or any other law.

(2) Any person intending to carry out any of the activities identified in sub-regulation (1) shall:

(a) comply with the provisions of these regulations;

(b) comply with all national and European Union regulations, including international obligations resulting from any treaty to which Malta may from time to time be a part of, as may be applicable;

(c) obtain the necessary authorisation from the competent authority;

(d) possess the necessary qualifications and have undergone any necessary training as may be required by the competent authority;

(e) comply with any other applicable law;

(f) have a medical device registered person in Malta; and

(g) insert details of all medical devices which he markets locally in the national medical device database kept by the competent authority.