Regulatory Focus™ > News Articles > Australia's Regulatory Body Takes Fire Over Medical Device Testing

Australia's Regulatory Body Takes Fire Over Medical Device Testing

Posted 05 March 2012 | By Alexander Gaffney, RAC 

Australia's Therapeutic Goods Administration (TGA) is taking fire from the Medical Journal of Australia (MJA) for a lack of medical device safety oversight, reports Fierce Medical Devices.

MJA wrote 5 March that "[t]here is minimal systematized collection of data about devices in clinical use that could supply relevant demographic data about patients using the drug or device, or data about the effectiveness and safety of the device in clinical practice."

MJA also lambasted TGA thinking, in the words of another editorialist, "they don't have a problem because they don't have the data to tell them they have a problem."


Read more:

Fierce Medical Devices - Australia's TGA slammed for device safety oversight

MJA - Don't leave regulation to its own devices


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