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TGA updates IVD regulations

TGA has finalised a series of amendments to the IVD regulations In a letter to stakeholders TGA summarised the changes as: An alternative conformity assessment procedure for Class 4 in-house…

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AHWP Bangkok meeting roundup

The Asian Harmonization Working Party met in Bangkok in November. It was a busy meeting with publication of a range of final guidance documents ranging from standard submission dossiers, software regulation,…