Proposed Final Document 'Regulatory mechanism for Medical Devices including In Vitro Diagnostic Medical Devices and Software as Medical Devices during a public health emergency'

Submitted by admin on Mon, 11/29/2021 - 04:12

After the receipt of comments from members and the review by the AHWP/GHWP leadership, the Proposed Final Document 'Regulatory mechanism for Medical Devices including In Vitro Diagnostic Medical Dev

Proposed Final Document 'Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices'

Submitted by admin on Fri, 11/26/2021 - 07:28

After the receipt of comments from members and the review by the AHWP/GHWP leadership, the Proposed Final Document 'Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices' will be proceeded for endorsement at The AHWP/GHWP 25th Annual Meeting.