AHWP Regulatory Framework for IVD Medical Devices
Please refer to the below attached with more information.
Thank you.
(WG1a here is referred to WG2 after the restructuring of work groups.)
Amendment 1 to the GUIDANCE for Member Economy Hosting the Meetings of AHWP or its Technical Committees
Please refer to the below attached with more information.
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GUIDANCE for Member Economy hosting the Annual Meetings of AHWP or its Technical Committees
1. The host organization of the Member Economy will normally be the national authority for the regulation of medical devices.
2. The host organization of the Member Economy will work together with its local industry association to promote the event locally. The host organization will be asked to provide a
Adoption of "Medical Device Adverse Event (AE) Report Form"
During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of "Medical Device Adverse Event (AE) Report Form".
Please refer to the below attached with more information.
Thank you.
(WG2 is referred to WG4 after the restructuring of work groups.)
Adoption of "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions"
During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions".
Please refer to the below attached with more information.
Thank you.
Adoption of "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1 - 5)"
During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1-5)".
Please refer to the below attached with more information.
Thank you.
(WG4 is referred to WG6 after the restructuring of work groups.)
Adoption of "The Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers"
During the 15th GHWP Meeting in Riyadh, it has been agreed the adaption of "The Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers".
Please refer to the below attached with more information.
Thank you.
Final Documents on Safety Alert Dissemination System (SADS) and Survey Post Market Surveillance System
The GHWP TC WG02 has finalized two documents on SADS, namely the GHWP/WG2/SADS/001: Framework for GHWP Safety Alert Dissemination System and GHWP/WG2/SADS/002: Safety Alert Dissemination Criteria, Procedures and Form, to be used for disseminating safety alerts amongst GHWP Member Economies.
Premarket Harmonization: Developing A Common Premarket Submission Dossier
To download the document, please click the document link below.
Attachment(s):