Proposed Final Document: Creation and Placement of Unique Device Identifier
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Creation and Placement of Unique Device Identifier will be proceeded for endorsement at The GHWP 28th Annual Meeting.
Proposed Final Document: Guidelines on Development of GHWP Documents - Part 2 Structure and Drafting
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidelines on Development of GHWP Documents - Part 2 Structure and Drafting will be proceeded for endorsement at The GHWP 28th Annual Meeting.
Proposed Final Document: Guideline on development of GHWP Documents - Part 1 Procedure for development
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guideline on development of GHWP Documents - Part 1 Procedure for development will be proceeded for endorsement at The GHWP 28th Annual Meeting.
Proposed Final Document: Guidance Document for Medical Device Organizations- Product Localisation for Manufacturing and Importation
After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidance Document for Medical Device Organizations- Product Localisation for Manufacturing and Importation will be proceeded for endorsement at The GHWP 28th Annual Meet
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.