S.L. 427.10 Art. 9Registration of persons responsible for placing devices on the market.

(1) Any manufacturer who has his registered place of business in Malta and, under his own name, places devices on the market in accordance with the procedure referred to in regulation

6(2) shall inform the Medicines Authority of the address of the registered place of business and the description of the devices concerned.

(2) All data allowing for the devices to be identified, together with the label and instructions for use, may be requested when such devices are put into service in Malta.

(3) (a) Where a manufacturer who places a device on the Maltese or Community market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.

(b) When the authorised representative referred to in paragraph (a) has a registered place of business in Malta, he shall inform the Medicines Authority of the details referred to in sub-regulation (1).

(4) The Medicines Authority shall, on request, inform the other Member States and the Commission of the details referred to in sub-regulation (2) given the manufacturer or authorised representative.