Final Documents endorsed in the 24th AHWP Annual Meeting in Oman, 2019 | GHWP

After consolidating the comments received from GHWP members by 10th November 2019, the PROPOSED FINAL documents developed by GHWP WGs, GHWP Secretariat, GHWP with APACMed and Deloitte have been endorsed as FINAL documents in the 24th GHWP Annual Meeting in Muscat, Oman.

Please find the Final Documents as attached in the following:

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WG2-WG1-WG3: Categorisation of Changes to a Registered Medical Device

WG9: Challenges and Recommendations for the Implementation of a Globally Coordinated UDI system

WG1-WG2-WG3: Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)

AHWP Secretariat: Amendment 6 to the Asian Harmonization Working Party House Rules

AHWP Secretariat: Amendment 7 to the Asian Harmonization Working Party (AHWP) & AHWP Technical Committee (AHWPTC) Terms of Refer

AHWP-APACMed-Deloitte: White paper on Competency Framework for Medical Technology Regulators