Japan Plans Pullback Of Regulations On Software as a Medical Device Technologies

Seeking to boost the domestic market for artificial intelligence software used to diagnose diseases, Japan is moving forward with plans to ease regulations on the technologies by shortening the product approval process and eliminating other requirements.

The proposed changes, which could go into effect this year, would primarily affect software as a medical device (SaMD) products, which use artificial intelligence and other software to diagnose, treat and prevent disease. Currently, Japan makes approval of such technologies much harder than the U.S. and other Western countries. Each software update is currently considered by regulators as a new product. Under the proposed regulatory change, scrutiny of such software updates would ease.  As of today, Japan has approved only one-tenth the number of SaMD products in Japan as compared to the US.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Source used in the article: https://asia.nikkei.com/Politics/Japan-to-ease-regulations-on-medical-AI-software#:~:text=TOKYO%20%2D%2D%20The%20Japanese%20government,by%20the%20end%20of%202022.