New Australian Guide Explains Oversight Of Clinical Decision Support Software
The Australian medtech regulator is urging sponsors of clinical decision support software to review their products to determine if these are regulated, exempted or excluded from regulatory oversight. Much depends on the intended purpose of these products, as stated by the manufacturer.
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The Australian health care products regulator is inviting feedback on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices.
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