GUIDANCE for Member Economy hosting the Annual Meetings of AHWP or its Technical Committees

Submitted by admin on Fri, 12/06/2013 - 16:20


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 "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions"

Submitted by admin on Fri, 11/23/2012 - 19:35


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)"

Submitted by admin on Fri, 11/23/2012 - 19:29


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"

Submitted by admin on Wed, 11/02/2011 - 16:35


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

Submitted by admin on Sun, 11/02/2008 - 15:40


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.