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Regulatory and Technical Consultative Forum for medical devices (RegTech Forum)
This information is intended for sponsors interested in activities and consultation processes regarding medical devices.
Purpose of RegTech
The purpose is outlined in the terms of reference:
- To prioritise and discuss issues of a regulatory and technical nature arising from current regulation and propose solutions.
- To provide a forum for members to raise regulatory or technical issues of concern, both current and emerging, faced by the TGA, the representative associations or members of the medical device sector generally.
- Identify opportunities to improve current regulatory practices and compliance.
Membership of RegTech comprises:
- Therapeutic Goods Administration (TGA)
- Medical Technology Association of Australia (MTAA)
- Australian Dental Industry Association (ADIA)
- Pathology Technology Australia
- Association of Therapeutic Goods Consultants
- Australian Medical Manufacturers & Distributors Association (AMMDA)
- Assistive Technology Suppliers Australia (ATSA)
- Optical Distributors & Manufacturers Association (ODMA)
- Consumer Healthcare Products Australia (CHP Australia)
RegTech meetings are usually held quarterly in Canberra at the TGA.
Devices Authorisation Branch
Phone: 02 6289 7071