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AHWP-DITTA Joint Session on Software as a Medical Device

23.11.2016 Category: DITTA Events

AHWP-DITTA Joint Session on Software as a Medical Device


DITTA - AHWP Joint Session was held on Nov. 23, 2016 during the week of the 21st AHWP Annual Meeting at Cebu, Philippines. AHWP, Asian Harmonization Working Party, was established in 1996-1997*1 and has been leading the regulatory harmonization of medical devices in member economies.*2 Currently the number of member economies are 26.*3 Those include not only the Asian countries but also countries from other continents such as Chile, South Africa, and Tanzania. At the AHWP Annual meeting, 4 new members were adopted, bringing the total member economies to 30. New members are Bahrain, Oman, UA Emirates, and Zimbabwe.

The relationship between DITTA and AHWP has been developed since 2012 when DITTA - AHWP Joint Workshop was held in Taipei. As the cooperative relation is being nurtured, DITTA has become an official liaison member of AHWP.

In this Joint Session the speakers’ main topic was SaMD, Software as a Medical Device, which is the standalone software used as a medical device. The moderator was Dr. Sethuraman Rama who is the chair of AHWP TC WG3 from HSA, the authority of Singapore. She emphasized the importance of software as a part of medical system and that the question how to maintain the safety of SaMD is the current major issue in the regulatory section. Mr. Tony Yip who is the Co-chair of AHWP TC WG3 made a presentation on the quality system of SaMD comparing the typical quality management system, ISO 13485, and IEC 62304. He analyzed the specific procedures for SaMD which should be taken carefully in the development planning. Mr. Keiichiro Ozawa who is the Chair of DITTA Medical Software WG made a presentation on IMDRF SaMD Clinical Evaluation draft document which was in public consultation on IMDRF website. And he called for the comments to the audience. Dr. Ir Peter W. J. Linders who is the Chair of DITTA Standardization WG made a presentation on the regulation of SaMD and mobile applications with emphasis on EU and US. For the EU, he briefly indi