Australia TGA Medical Device Regulatory Requirements

At the end of this short course, successful learners will be able to:

• Understand the TGA’s regulatory framework for medical devices, including device classification and regulatory controls
• Identify requirements for ARTG inclusion, including evidence requirements and conformity assessment procedures
• Apply Australian labelling and advertising requirements, including consumer health protection laws
• Understand obligations of sponsors, including post-market monitoring, incident reporting, and recalls
• Navigate the role of MDSAP, international equivalence, and current regulatory reforms

This course is for individuals or organizations who want to understand Australia TGA Medical Device Regulatory Requirements.

Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.

In order to successfully complete this course, each Learner will need to:

• Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.