Module 19 2021

01/06/2021

Requirements in the major markets

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The big regulated markets - USA

The world biggest IVD market Regulator is the FDA IVDs are regulated as medical devices ● Three risk classifications I,II and III Regulated under CFR Part 820 but also consider 801, 803, 806, 807, 809, 812, 821,822, 830. Risk Management approach Registration is not required for Class I devices that are exempted Class II devices require a 510(k) submission and a file review. Measure substantial equivalence (SE/NSE)

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