6AKind of information—medical devices intended for export only

6A Kind of information—medical devices intended for export only

(1) An application for a medical device that is intended by the manufacturer to be for export only, including an IVD medical device, must be accompanied by the following kind of information:

(a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Schedule 2A, which is recognised by the regulatory authority in column 2 of that item; and

(b) a conformity assessment document in relation to the medical device specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

(2) To avoid doubt, a document which accompanies the application in accordance with this section must relate to the kind of device to which the application relates.

Application of this section

(3) This section does not apply to a medical device used for a special purpose.