Submission of applications to the Japanese authority now mandates usability engineering. The international standard IEC 62366-1, governing usability engineering in medical device development, transitioned into a JIS standard in 2019 and was updated as JIS T62366-1:2022 in February 2022. JIS T 62366-1 outlines the usability engineering process for analyzing, specifying, developing, and evaluating the safety-related usability of medical devices. If followed, the process ensures an acceptable safety-related usability unless there is evidence to the contrary. Compliance is verified through the usability engineering file, emphasizing a focus on safe user interfaces for all types of medical equipment, not just electrical. The MHLW in Japan demands adherence to the revised JIS by March 31, 2024.
In late January 2024, Singapore’s HSA announced the 10th update to the “GN-15 Guidance on Medical Device Product Registration” document with a significant amendment affecting the device evaluation routes for Immediate Class B registration and expedited Class C registration. The main change is the removal of the requirement for a marketing history in Singapore as a qualification criterion. Now, for these evaluation paths, medical devices must have been approved and marketed for at least three years in one of the reference regulatory agencies such as Health Canada, Japan’s MHLW, the US’s Food and Drug Administration, the Australian TGA, and the European Union Notified Bodies.
Malaysia’s MOH will crackdown on sales of non-registered medical devices on business and media platforms. To do so, the Medical Device Act of 2012 will be amended to help protect Malay citizens and quality standards.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------