Public-Private Collaboration Needed to Refine SaMD Regulatory System
To read the full story
Related Article
- JaDHA Creates Hypothetical Case Collection to Push Two-Stage Approval of SaMD
October 11, 2024
- MHLW Notification Outlines 2-Stage Approval Scheme for SaMD
November 21, 2023
- With 2nd Strategy Penned, Can Japan Play Catch-Up with US & Europe in SaMD Push?
October 3, 2023
- Japan Unveils 2nd Package Strategy for SaMD
September 7, 2023
- MHLW to Unveil Draft of 2nd Package Strategy for SaMD on Sept. 6
August 31, 2023
- Chuikyo Subcommittee OKs Basic SaMD Reimbursement Rule
November 16, 2021
- PMDA’s SaMD Consultation Desk Handling 30 Inquiries per Month
November 16, 2021
- Industry Calls for Simplifying Regulatory Process for SaMD
October 26, 2021
- Japan Drug Makers Prepping to Launch New Organization to Solve Challenges in Digital Health
October 13, 2021
- MHLW Aims to Set Up Evaluation Index, Sakigake System for SaMD by March
June 18, 2021
- MHLW Launches New Office to Fuel SaMD Commercialization
April 6, 2021
- MHLW Formulates Package Strategy for SaMD Commercialization, Eyes Sakigake Scheme
November 26, 2020
COMMENTARY
- TSE’s Growth Market Reform Puts Pressure on Biotechs
January 27, 2026
- Wave of “World Firsts” Looms as 47 New Drug Candidates Line Up for 2026
January 6, 2026
- Radioligand Therapy Faces Capacity Bottleneck in Japan, System Build-Out Needed to Deliver on Promise
December 22, 2025
- FY2026 Reform Debate for Drug Pricing Nears the Finish Line, Balance Needed
December 9, 2025
- MOF Autumn Proposals Signal a Shift from Drug Pricing to Cost-Sharing Reform
November 17, 2025
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…





