GHWP Capacity Building successfully held

Submitted by admin on Fri, 12/01/2023 - 02:24

At 9:00 a.m. (Beijing time) on November 27, 2023, the 27th GHWP Annual Meeting and TC Meeting was grandly kicked off in Shanghai, China. The Global Harmonization Working Party (GHWP) was established in 1997, the predecessor of which was the Asian Harmonization Working Party (AHWP). GHWP is an international organization with long history and wide membership.

Proposed Final Document: Guidance on the Risk-Based Approach to Quality Management System Aspects: ISO 13485:2016

Submitted by admin on Tue, 11/28/2023 - 19:29

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidance on the Risk-Based Approach to Quality Management System Aspects: ISO 13485:2016 will be proceeded for endorsement at The GHWP 27th Annual Meeting.

Proposed Final Document: Guidance for Additional Considerations to Support Conformity Assessment of In vitro Companion Diagnostic Medical Devices

Submitted by admin on Mon, 11/27/2023 - 20:21

 

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidance for Additional Considerations to Support Conformity Assessment of In vitro Companion Diagnostic Medical Devices will be proceeded for endorsement at The GHWP 27th Annual Meeting.

Proposed Final Document: A Guide to Understanding Best Practices in Audit Life Cycle Management

Submitted by admin on Mon, 11/27/2023 - 19:57

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: A Guide to Understanding Best Practices in Audit Life Cycle Management will be proceeded for endorsement at The GHWP 27th Annual Meeting.