Easing of regulations for AI-based medical devices to empower domestic market in Japan, observes GlobalData

With the emergence of diagnosis and medical treatment supported by artificial intelligence (AI) expected to replace the competencies of creativity and ideation in the medical device industry, Japan plans to ease regulations for AI-based devices. Subsequently, this is likely to empower the domestic medical device market, finds GlobalData, a leading data and analytics company.

GlobalData’s research reveals that Japanese medical devices market, which accounted for 20% of the Asia-Pacific market in 2021, is expected to grow at a compound annual growth rate of 2% through 2030.

The Japanese authority, on receiving an application to accredit the software, takes three months approximately to approve, and an extra indefinite period to initiate the review process before the final approval.

Ayshi Ganguly, Medical Devices Associate Analyst at GlobalData, comments: “However, with the new promising initiative of implementing AI to domestic devices with a parallel improvement of the approval tenure by Japan, it is expected to accelerate the existing approval process and further re-establish a faith in recovering the domestic market.”

The use of AI in daily used medical devices such as X-ray machine, which uses software like SaMD, will not only enhances diagnostic approaches for doctors, but also makes it less cumbersome in detecting shadows and lesions from X-ray images, or predicting tumors from colonoscope images.

Ganguly concludes: “The new age AI-based revolution incorporated in medical devices in Japan is expected to curb the efforts of proofreading every software update, curtail the product reviews, and incorporate safety and efficacy throughout the process.”

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