Conclusion The change will help the TGA confirm various factors important to determine if a manufacturer has the appropriate data and is the classification is correct for Class I Medical Device and the anticipated impact of the review is of up to 4 business days, so it should not impact manufacturers much while providing TGA with the ability to better regulate this Class of Medical Devices
Mild Beckwith-Wiedemann and severe long-QT syndrome due to deletion of the imprinting center 2 on chromosome 11p
Passeron T, Lim HW, Goh CL, Kang HY, Ly F, Morita A, et al
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Mopidevi, S.M.V
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