Regulations

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Europe Government Medical Devices New Content Regulations

Medical device regulations evolve for Australian innovators with European ambitions

By Australian Health Journal — 2 weeks ago

Medical device regulation is undergoing significant change as regulators across major jurisdictions grapple with the rapid growth of software and artificial intelligence (AI) in healthcare.

Speaking with Australian Health Journal at the Medical Technology Association of Australia’s RegConnect Summit 2026 in Sydney in September, Gabrielle Cesvet, Head of Public Affairs at Scarlet, said manufacturers need greater clarity and sufficient lead time as new regulatory frameworks emerge.

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Clinical Trials Human Research Ethics Committee (HREC) New Content Regulations

Report gives insights to clinical trial activity in Australia

By Australian Health Journal — 1 year ago

Established in 2024, Bellberry is a Adelaide-based national, not-for-profit organisation that provides streamlined scientific and ethical reviews of human research. It is the 2025 winner of the Championing Health Award in the Telstra Best of Business Awards.

Australian Health Journal spoke with Bellberry Limited CEO, Kylie Sproston on the organisation and the findings in activity documented in the Clinical Trial Activity Report (CTAR) 2024.

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Medical Devices Medical Technology Association of Australia New Content Patients Regulations Training and Career

Ensuring stringent quality standards in the lifecycle of medical devices

By Australian Health Journal — 3 years ago

Dr Jasjit Baveja is the Associate Director of Policy at the Medical Technology Association of Australia (MTAA), where she oversees regulatory affairs, clinical code of practice, procurement, industry policy, reimbursement, and advocacy. With over 20 years of experience in the medical device regulatory space, Dr Bavej’s expertise lies in providing educational opportunities for regulatory professionals in Australia to ensure continuous learning and professional development. She collaborates closely with the Therapeutic Goods Administration (TGA) to run workshops that provide invaluable experience, networking opportunities, and skill enhancement.

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