TGA conformity assessment certification
Information on medical device conformity assessment and where it is required.
The following pages contain information and guidance for manufacturers who intend to submit an application for TGA-issued Australian conformity assessment certificate.
Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the essential principles.
From 28 July 2021, devices that were previously described under regulation 4.1 (those that contain medicines or materials of animal, microbial, recombinant or human origin, and Class 4 IVDs) no longer require mandatory TGA conformity assessment certification.
- Australian declaration of conformity templates (medical devices)
- Australian declaration of conformity templates (IVDs)
- Conformity assessment certificate repository
- Revocation of a TGA issued Conformity Assessment Certificate
- Post-market evaluation of serology-based point of care tests
- Meet safety, performance and quality requirements for medical device manufacturers
- Standards orders and medical devices