THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4A.14 Conditions--producing information and documents

THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4A.14

  (1)   The Australian conformity assessment body will, if requested to do so by the Secretary, give the Secretary information, or produce to the Secretary documents, that concern certification - related activities carried on by the body.

  (2)   The information will be given, or the documents produced, within the period, of not less than 20 working days after the day the notice is given, specified in the notice.

  (3)   The Australian conformity assessment body will have procedures, including a written agreement, in place with each of:

  (a)   its clients; and

  (b)   the contractors of the body that carry on certification - related activities for the body;

that require the client or contractor to make available information or documents that the client or contractor has that is requested under subregulation   (1).