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- Title
Device regulation: what next?
- Authors
Graves, Stephen E.; Maddern, Guy J.
- Abstract
The author reflects on the enhancement of medical device regulation by improving the transparency and communication to the public about the assessment of a certain device. He informs that in Australia, the device regulation has undergone several reviews and evaluations before approval and even after the device has been presented in the market. The publicized defective breast implants device of Poly Implant Prothèse (PIP), which brings out the regulatory issues, is also discussed.
- Subjects
AUSTRALIA; MEDICAL equipment laws; ORGANIZATIONAL transparency; COMMUNICATION
- Publication
Medical Journal of Australia, 2012, Vol 196, Issue 4, p222
- ISSN
0025-729X
- Publication type
Editorial
- DOI
10.5694/mja12.10230