KD&A News

Medical Device Software – Potential for Consistent Regulation in Asia

Posted by:
July 7, 2014
in: Medical Technology Regulation, News, Uncategorized


The Asian Harmonization Working Party (AHWP) has published a white paper on medical software for comment. The AHWP has developed the paper in conjunction with the EU and the US with the aim of developing a consistent approach for a regulatory framework for medical software to be shared among the AHWP.

Singapore has been a primary contributor to the paper which provides an overview of requirements in place for medical device software in larger jurisdictions such as Australia, the US, EU, Japan, and Canada.

In a story published by Clinica, Peter Linders, co-convenor of the international health software product safety standard, IEC 82304-1, said “I expect that the analysis is likely to lead to a new project to develop regulatory recommendations for AHWP member economies.” Work is being carried out in a truly international context and Mr Linders and the team working on IEC 82304-1, a joint IEC/ISO project for a health software product safety standard, are in regular dialogue with the regulatory bodies of the countries represented by the AHWP.

Click here for a copy of the white paper.

 


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