Submitted by admin on Wed, 09/28/2016 - 22:25

They are spearheaded by the diligent efforts of a group of committed regulatory affairs professionals in Asia Pacific. We have gained momentum from the growing interest of regulators in working towards greater harmonization of medical device regulations in Asia and in the efforts of Global Harmonization Task Force.

Future Directions

-Organise awareness education, training and seminars for medical device regulators and industry in the area of regulatory requirements (such as Essential Principles of Safety and Performance of Medical Devices; Classification Rules and risk-based management approach) and premarket review processes. One possibility is to tap the availability of GHTF SG resource persons on business trips or visits to Asia;

-Define the scope and deliverables and tasks of Technical Committee, including the conduct and frequency and venue of meetings;

-Seek budgetary and strategic support for AHWP activities and programmes;

-Establish an effective communication network and presence amongst participating Asian economies through scheduled AHWP meeting, e-mails, correspondence and Internet-based access site;

-Plan for the next AHWP Meeting;

-Work towards enlarging the base of participating economies so as to maximise the benefit of the GHTF harmonization process to Asia.