Asian Harmonization Working Party Medical Device Updates

The Asian Harmonization Working Party (AHWP) posted their summary report on December 31, 2009 about their latest meeting in Hong Kong. The 14th AHWP meeting took place on November 6-7, 2009.

During the meeting, AHWP members discussed their work plan and targets of focus. The first target is to compile the experiences of participants in the AHWP Common Submission Dossier Template (CSDT) pilot program. The Safety Alert Dissemination System (SADS) will also be fully implemented.

Other future tasks include a single nomenclature system and Unique Device Identified (UDI) system and a classification system. In addition, the AHWP training capacity will be enlarged, including an AHWP training program and AHWP workshop funded by the Asia-Pacific Economic Cooperation (APEC). Also, AHWP guidance documents for implementing Global Harmonization Task Force (GHTF) principles for quality management system (QMS) requirements will be drafted.

The next 15th AHWP meeting will be held in the Kingdom of Saudi Arabia. No date has been set as of now.