The Pharmaceuticals and Medical Devices Agency’s (PMDA) central consultation desk on software as a medical device or SaMD has handled around 30 inquiries per month since it was set up in April, according to a health ministry official. The number…
To read the full story
Related Article
- Public-Private Collaboration Needed to Refine SaMD Regulatory System
November 26, 2021
REGULATORY
- Japan Cabinet Approves National MCM Strategy to Boost Pandemic Response
March 25, 2026
- Pharma Urges Govt Support as Iran War Shows Early Impact on Supply Chains
March 25, 2026
- Japan Panel Slams MHLW’s 80% Single-IRB Target as Too Low
March 24, 2026
- Ishin Proposes Macroeconomic Indexing for Healthcare as LDP Talks Resume
March 24, 2026
- Japan OKs Bayer’s MRI Agent, Haihe’s PI3Kα Med, Enhertu’s Tumor-Agnostic Use, and More
March 24, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





