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What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs

Version 1.0, November 2011

24 November 2011

Book pagination

TGA conformity assessment certificates

Application process flowchart

Application process flowchart

Text version of OTC application placement flowchart

This text representation of this flowchart is provided as a list with numbered steps.

  1. Applicant* arranges pre-submission meeting with TGA staff (optional)
  2. Applicant* submits eBusiness application and pays application fee
  3. TGA writes to Applicant providing Submission ID and requests supporting documentation to allow determination of the level of assessment needed
  4. Applicant provides requested supporting information
  5. TGA determines level of assessment needed and invoices assessment fees
  6. Applicant pays assessment fees
  7. TGA conducts assessments, including an onsite quality system audit, if appropriate
  8. If requirements are met, TGA issues Conformity Assessment Certificate
  9. Ongoing TGA surveillance activities/audits
  10. Recertification prior to expiry of certificate

*Applicant may be a manufacturer or their agent or representative.

Book pagination