Regulation 35

must supply the medical device by wholesale only to a person who may lawfully supply such medical devices in accordance with the Act and these Regulations;

must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling, storage and distribution of the medical device as are necessary to prevent the deterioration of the medical device while it is in the wholesaler’s ownership, possession or control; and

if the wholesaler is the holder of a wholesaler’s licence for the medical device —

must, if required under these Regulations, ensure, and maintain objective evidence to establish, that the handling, storage and distribution of the medical device complies with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485; and

must not use, for any purpose mentioned in paragraph (b), any premises other than the premises specified in the licence, or any other premises that the Authority may approve from time to time.