IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices
This course explains what conformity assessment means and examines the process for obtaining a Conformity Assessment Certificate from the Australian Therapeutic Goods Administration (TGA), including the timeframes for assessment. It explains what happens once an application is determined as successful or not, and the ongoing responsibilities of the manufacturer once a certificate has been obtained.
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Upon completion of this course, trainees will
- understand the circumstances in which a TGA Conformity Assessment Certificate is required;
- understand the process, requirements and responsibilities for making an application for a TGA Conformity Assessment Certificate; and
- know what documents the TGA will request to support an application for certification.
Regulatory affairs professionals driving market access for IVDs in Australia.