Proposed Final Document: Comparison study of ISO 13485 vs. QMS requirements in GHWP member countries or regions
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Comparison study of ISO 13485 vs. QMS requirements in GHWP member countries or regions will be proceeded for endorsement at The GHWP 28th Annual Meeting.
Proposed Final Document: Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions will be proceeded for endorsement a
Proposed Final Document: Change Management to Registered Medical Devices
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Change Management to Registered Medical Devices will be proceeded for endorsement at The GHWP 28th Annual Meeting.
Proposed Final Document: Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative will be proceeded for endorsement at The GHWP 28th Annual Meeting.
Proposed Final Document: Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative will be proceeded for endorsement at The GHWP 28th Annual Meeting.
GHWP 28th Annual Meeting Pragramme
Please have the attached Annual Meeting Pragramme (Day 1- Day 4) of GHWP 28th Annual Meeting and 28th GHWP Technical Committee Meeting to be held 9th - 12th December 2024, in Kuala Lumpur of Malaysia.
Proposed Final Document: Amendment 11 to GHWP TOR and House Rules
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Amendment 11 to GHWP House Rules will be proceeded for endorsement at The GHWP 28th Annual Meeting.
Proposed Final Document: Amendment 9 to GHWP TOR and House Rules
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Amendment 9 to GHWP Terms of Reference and House Rules will be proceeded for endorsement at The GHWP 28th Annual Meeting.
Proposed Final Document: Amendment 10 to GHWP TOR and House Rules on Management Committee
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Amendment 10 to GHWP TOR and House Rules on Management Committee will be proceeded for endorsement at The GHWP 28th Annual Meeting.