International AHWP identifies areas for medtech regulatory convergence

摘要

The Asian Harmonization Working Party has identified ten areas where it believes there is "most potential for success" in harmonising the medtech regulatory requirements of its 23 member economies.These key areas were identified as part of AHWP's plan to develop its "Strategic Framework Towards 2020". The proposed framework, when finalised, is expected to provide the AHWP with a clear development plan and targets to enhance the medtech regulatory capabilities of its member economies.Specifically, the AHWP is keen on achieving regulatory convergence in the following areas within a defined timeframe: adopting a harmonised definition of the term "medical device" (this is important as it will help determine what and who are subject to regulation);