Course Description

IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices

Course Description:

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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Learning Objectives:

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.

Who Should Enroll:

Regulatory affairs professionals driving market access for IVDs in Australia.

Prerequisite Knowledge/Requirements:

IDN150 Basics for Including an IVD on the ARTG 

Subject Matter Expert:
Shelley Tang

40 min

Release date:

Related resources:

Case studies:

Basic Account: € 160.00
Premium Account: € 120.00

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