Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies in relation to the following kinds of medical devices:
(a) a Class 3 IVD medical device;
(b) a Class 4 IVD medical device;
(c) a Class 4 in - house IVD medical device;
(d) an IVD medical device that is intended for self - testing;
(e) an IVD medical device that is intended for point of care testing;
(f) a spinal fusion implantable device.
Note: For the purposes of paragraph (f), examples of spinal fusion implantable devices include screws, cages, plates, hooks or rods that are intended to be used during spinal fusion surgical procedures.
(2) For t he purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must give the Secretary a written notice if:
(a) the person intends to import, supply or export a medical device of that kind; and
(b) either of the following is not included in the Register:
(i) the product name of the device;
(ii) information in relation to the manufacturer's intended purpose of the device.
(3) The notice must:
(a) specify the information mentioned in paragraph (2)(b) that is not included in the Register; and
(b) be given to the Secretary no later than 20 business days before the intended import, supply or export of the device.