Document ID: chunk:federal_register_of_legislation:F2022C01065:reg:54a:p1
Version: federal_register_of_legislation:F2022C01065
Segment Type: reg
Provision Reference: reg 54A (pt 1/2)
Character Range: 337448–340108

54A  Test kits

Classes of goods to which this section applies
 (1) The class of goods to which this section applies is test kits that contain animal material, human material or material derived from a disease agent.

Conditions
 (2) Goods included in the class of goods to which this section applies must not be brought or imported into Australian territory unless:
 (a) the goods are covered by an import permit; or
 (b) the alternative conditions specified for the goods in subsection (3) are complied with.
 (3) For paragraph (2)(b), the alternative conditions for bringing or importing the goods into Australian territory are:
 (a) the goods are a medical device that is included in the Register (within the meaning of the Therapeutic Goods Act 1989); and
 (b) the goods have not been included in the Register for the sole purpose of being brought or imported into Australia for export only; and
 (c) the goods are an immunochromatographic device; and
 (d) the goods are finished goods that are packed in their final packaging; and
 (e) the goods have been manufactured using a production process that implements validated methods of elimination or inactivation of disease agents present in the goods; and
 (f) the goods are not intended for veterinary therapeutic use; and
 (g) no animal or plant is, or will be, exposed (whether directly or indirectly) to the goods or any derivatives of the goods; and
 (h) the animal material, human material or material derived from a disease agent that is contained in the goods is:
 (i) adhered to an inert membrane substrate; or
 (ii) in a solution; or
 (iii) both adhered to an inert membrane substrate and in a solution; and
 (i) if the animal material, human material or material derived from a disease agent is in a solution:
 (i) the solution is an integral component of the test kit; and
 (ii) the amount of the material contained in each solution that is a component of the test kit does not exceed 2 mL; and
 (j) the goods are accompanied by written evidence from, or a written declaration by, the manufacturer of the goods stating:
 (i) whether the animal material, human material or material derived from a disease agent that is contained in the goods is adhered to an inert membrane substrate, in a solution or both; and
 (ii) that the goods have been manufactured using a production process that implements validated methods of elimination or inactivation of disease agents present in the goods; and
 (iii) if any of the animal material, human material or material derived from a disease agent contained in the test kit is in one or more solutions that are a component of the test kit—that the material