For your kind perusal, please find attached the WG7 Proposed Document 'Comparison Study of new ISO13485 vs. QMS requirements in GHWP member economies'.
For your kind perusal, please find attached the WG3 Proposed Document 'Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions '.
For your kind perusal, please find attached the Proposed Document 'Amendment 10 to GHWP TOR and House Rules on GHWP Management Committee'.
Kindly send your comments with the template attached to the GHWP Secretariat (secretariat@ghwp.info) on or before 9 November 2024 (Saturday) 12:00noon (GMT+8). Thank you.
For your kind perusal, please find attached the Proposed Document 'Amendment 9 to the Global Harmonization Working Party Terms of Reference and House Rules'.
For your kind perusal, please find attached the WG9 Proposed Document ''UDI Data Elements'.
Kindly send your comments with the template attached to the GHWP Secretariat (secretariat@ghwp.info) on or before 18 October 2024 (Friday) 12:00noon (GMT+8). Thank you.
