Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must:
(a) create a record of information of a kind referred to in regulation 5.8 that relates to that kind of device as soon as practicable after the person becomes aware of the information; and
(b) create a record of information in relation to the distribution by the person of each device of that kind as soon as practicable after the distribution.
(2) A record created under subregulation (1) must be kept:
(a) for 10 years if the record relates to one of the following kinds of device:
(ii) a Class III medical device;
(iii) a Class IIb medical device that is an implantable medical device;
(iv) a Class 4 IVD medical device; or
(b) for 5 years if the record relates to any other kind of device.