Therapeutic Goods Act 1989

After making a decision whether to issue a conformity assessment certificate, the Secretary must:

notify the applicant in writing of his or her decision within 20 working days; and

if the decision is not to issue the certificate—state in the notice the reasons for the decision; and

if the decision is to issue the certificate and all assessment fees that are due and payable for the application have been paid:

issue the certificate to the manufacturer in relation to whom the application was made; and

give the applicant a copy of the certificate (if the applicant is not the manufacturer).

A conformity assessment certificate must specify whether it covers:

all medical devices manufactured by the manufacturer; or

only specified medical devices manufactured by the manufacturer.

A conformity assessment certificate must contain any other information prescribed by the regulations for the purposes of this subsection.