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What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
Version 1.0, November 2011
Issue of certificates
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.