Capacity Building – Free online training on GHWP Guideline Reagent Replacement and Instrument Family Policy by Dr. Adelheid Schneider on 7th January 2025

Please note the meeting minutes of the 28th GHWP Annual Meeting, Kuala Lumpur, 12th December 2024, as follows:

Please have the attached Annual Meeting Pragramme (Day 1- Day 4) version 2 of GHWP 28th Annual Meeting and 28th GHWP Technical Committee Meeting to be held 9th - 12th December 2024, in Kuala Lumpur of Malaysia.

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: UDI Data Elements will be proceeded for endorsement at The GHWP 28th Annual Meeting.

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.

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.

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.

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

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.

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