Medical device changes

January 15, 2013

THE TGA has published a proposal paper for changes to premarket assessment requirements for medical devices. The proposal paper is seeking to: refine a risk-based approach to regulation; ensure that the TGA undertakes a more comprehensive review of higher risk medical devices, in particular implantable and surgically invasive medical devices intended for long term use; increase transparency and accountability of the TGA's decision making; and allow Australian manufacturers of lower risk medical devices to have the option of European Conformity assessment for supply of their devices in Australia. Interested parties should respond by close of business Friday 15 March 2013, see www.tga.gov.au.

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Pharmacy Daily | Medical device changes

Medical device changes

Other recent headlines

PD breaking news – Pharmacists to administer NIP vaccinations in aged care

PD breaking news – Top Western Australian talent honoured

Legal action for Montu

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES