Australian jurisdictional update Dr Cheryl McRae Therapeutic Goods - - PowerPoint PPT Presentation

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Oct 24, 2023 166 likes •211 views

Australian jurisdictional update Dr Cheryl McRae Therapeutic Goods Administration Premarket 1. Expert review of regulation of medicines and medial devices 2. IVD framework amendments 3. Up-classification of Class IIb joints 4. De-regulation

SLIDE 1

Australian jurisdictional update

Dr Cheryl McRae Therapeutic Goods Administration

SLIDE 2

Premarket

1. Expert review of regulation of medicines

and medial devices

2. IVD framework amendments
3. Up-classification of Class IIb joints
4. De-regulation agenda
5. International engagement

SLIDE 3

Post market

1. Development of a new Adverse Event

Management System

2. Future work includes developing a web

service to allow manufactures to report directly

3. Sentinel site pilot
4. Review/consultation with stakeholders