Australian regulatory guidelines for medical devices: Part ...
Risk vs Regulatory Requirements. Class of Device Regulatory Requirements (Increasting) Quality System Class I Classes Is, Im, IIa Class IIb Classes III/AIMD 0 43 90 130 Design/Type Control Class I Classes Is, Im, IIa Class IIb Classes III/AIMD 0 0 0 80 Product Class I Classes Is, Im, IIa Class IIb Classes III/AIMD 20 36 83 250 ................
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