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Regulatory News | 31 October 2014 | By Alexander Gaffney, RAC
The medical-device focused Asian Harmonization Working Group (AHWP) has released a new document meant to eventually help provide a common approach for the regulation of medical device software.
The draft version of the document was released in July 2014, and provided a high-level overview of the regulatory approaches taken by major economies--the US, EU, Australia and China—toward the regulation of software as a medical device (SaMD).
The overall goal of the white paper is to work toward the adoption of a position "on the qualification and classification of SaMD, with a view to align as far as possible to global harmonisation or convergence of SaMD guidelines," AHWP writes in the final paper. The paper also says AHWP might consider the adoption of international software standards to make compliance easier.
AHWP's member economies include Abu Dhabi, Brunei, Cambodia, Chile, China, Taiwan/Chinese Taipei, Hong Kong, India, Indonesia, Jordan, Saudi Arabia, Laos, Malaysia, Myanmar, Pakistan, the Philippines, South Korea, Singapore, South Africa, Kuwait, Thailand, Vietnam and Yemen.
Tags: AHWP, SaMD, Software, Software as a Medical Device, White Paper, Asian Harmonization Working Party