Therapeutic Goods Act 1989

devices of the kind in question are medical devices; and

devices of that kind are intended for a specified purpose, as ascertained under subsection 41BD(2); and

the kind of device is correctly classified according to the medical device classifications; and

devices of that kind comply with the essential principles; and

the applicant:

has available sufficient information to substantiate that compliance with the essential principles; or

has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

either:

appropriate conformity assessment procedures have been applied to devices of that kind; or

requirements, comparable to the conformity assessment procedures, have been applied to devices of that kind; and

the applicant:

has available sufficient information to substantiate the application of the procedures referred to in subparagraph (f)(i) or the requirements referred to in subparagraph (f)(ii); or

has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

both of the following are complied with in relation to devices of that kind:

the applicable provisions of the Therapeutic Goods Advertising Code;

the other requirements (if any) relating to advertising applicable under Part 5‑1 or 5‑1A or under the regulations; and

if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3):

if those prohibitions cover imports—any imports into Australia of devices of that kind by, or on behalf of the applicant, will not contravene those prohibitions; and

if those prohibitions cover exports—any exports from Australia of devices of that kind by, or on behalf of the applicant, will not contravene those prohibitions; and

if those prohibitions cover manufacture—any manufacture in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those prohibitions; and

if those prohibitions cover supplies—any supplies in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those prohibitions; and

if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions:

if those prohibitions cover imports—any imports into Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and

if those prohibitions cover exports—any exports from Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and

if those prohibitions cover manufacture—any manufacture in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and

if those prohibitions cover supplies—any supplies in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and

devices of that kind do not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and

devices of that kind are not to be used exclusively for one or more of the purposes specified under section 41BEA; and

the information included in or with the application is complete and correct.

See section 41BH for when a medical device complies with the essential principles, section 41BI for when conformity assessment procedures are taken not to have been applied to a medical device and section 41BIA for when requirements comparable to those procedures are taken not to have been applied to a medical device.