After consolidating the comments received from GHWP members, the PROPOSED FINAL documents developed by GHWP WGs and GHWP Secretariat have been endorsed as FINAL documents in 2017. The documents are attached in the following. Download file Handbook for Approval of Patient-matched Medical Devices Using 3D Printers Regulation and treatment of e-IFU and e-Label of Medical Devices-Review of International Practice Guidance for Additional Considerations to support Conformity Assessment of Companion In vitro Diagnostic Medical Devices Post Market Clinical Follow-Up Studies Clinical Investigation Amendment 5 to the Asian Harmonization Working Party House Rules Amendment 6 to the Asian Harmonization Working Party (AHWP) & AHWP Technical Committee (AHWPTC) Terms of Reference (TOR)
