Certificates will be issued to the manufacturer once:
the assessment of the device's compliance to the Essential Principles is satisfactorily completed
the quality system audit (if conducted) is closed out - all non-conformities are resolved
all clearances (including the Fit and Proper Person certification) are completed
all fees (assessment, additional audit fees) are paid in full.
The applicant will be given an explanation and statement of reasons for any refusal to issue, or restriction on, the TGA Conformity Assessment Certificate. The decision is also appealable, subject to the legislative appeal provisions.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.