Australian Medical Device Registration Bootcamp

This Bootcamp is tailored for medical device companies in the following categories:

• Planning for Regulatory Approval: If you’re planning to submit your medical device products for regulatory approval in the next two years, this boot camp is essential. Gain the knowledge and strategies to ensure a smooth submission process.

• Expanding to Australia: For companies with products registered outside Australia and looking to expand their market presence down under, this boot camp provides invaluable insights on registering your products in Australia.

Our boot camp will feature intensive half-day session in Perth, ensuring you receive in-depth knowledge and guidance. Whether you’re planning to submit a new product for registration or need post-registration follow-up insights, our boot camp will have you covered. Gain practical insights and strategies to ensure a smooth submission process. Engage in discussions with TGA experts in dedicated breakout rooms. Get your burning questions answered and benefit from the collective wisdom of your peers.

Agenda for the Event

• Introduction to the Therapeutic Goods Administration (TGA) and its role in device registration.

• Application Pathways

• What does the TGA look for in a Quality Submission

• Medical Devices Registrations (IVD, CMD, SMD’s)

• Post-market Compliance and Activities

Please note that this is not a generic session. We expect participants to have a reasonable understanding of medical device regulatory submissions in Australia. This boot camp is tailored for those actively involved in the medical device industry.

Ready to boost your medical device registration game? Please Register for our boot camp.

If you have any questions, please email us at Redic.proposal@mtpconnect.org.au.