Pharmacy Daily | TGA to consult on devices

THE Therapeutic Goods Administration is inviting submissions on the regulation of medical devices in Australia, as part of its ongoing reform agenda. The TGA will hold public hearings in Canberra, Sydney, Melbourne and Adelaidethis month, and stakeholders are also able to make written or online submissions. “As technology advances and the population ages many more Australians are using high-risk medical devices, such as joint implants, implantable pacemakers and breast implants, and people are looking to the TGA to provdie them with confidence in the safety and performance of imported devices, while reducing the regulatory burden on Australian manufacturers of lower risk medical devices,” said Parliamentary Secretary for Health, Catherine King. The discussion paper, which is available at www.tga.gov.au, with recommendations including improvement of post-marketing surveillance “to better inform premarket regulatory decision making”. The proposals also remove the requirement for Australian medical device manufacturers to hold TGA conformity assessment certification, as well as reclassifying all hip, knee and shoulder joint replacement implants from Class IIb to Class III medical devices. The TGA is inviting submissions on the discussion paper through until close of business on 17 Dec to odaconsult@tga.gov.au.

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