Navigate global digital health regulatory pathways
Navigating global pathways to scale digital health technologies (DHTs) is complex. These resources are designed to help you with actionable insights to understand and compare regulatory environments across Asia Pacific, Europe, and North America. With country-specific guides, step-by-step flowcharts, and supporting resources, you’ll be equipped to streamline your go-to-market strategies and bring your digital health innovations to patients worldwide faster and more efficiently.
Scale your DHT in key global markets
Assess key global market pathways to bring your DHT through the regulatory process and into patients’ hands. Select a country below to explore further.
Asia Pacific
North America
Countries at-a-glance
Don’t see your country? Partner with DiMe to add it to our database, enabling developers to enter your market and reach more patients.
See how others have done it
Explore case studies of companies successfully navigating regulatory landscapes, offering insights into market entry strategies and effective evidence generation.
How will you use these resources in your work? Let us know here, to be featured on our social media and Resource in Action hub.
Do you have a story to share, like these companies? Email regulatory@dimesociety.org to discuss sponsoring the expansion of this collection.
Project partners
DiMe’s global project, International Regulatory Pathways, builds upon the success of the Digital Health US Regulatory Pathways project by combining the expertise of global leaders from across the digital health technology (DHT) industry to foster innovation, drive progress, and harmonize regulatory efforts.
Resources to support your path to market
Library of Digital Health Regulations
Navigating emerging global AI regulations: How-to guide for DHT developers
Looking to navigate AI/ML-specific regulatory pathways? This resource covers evidence requirements and market entry strategies for AI-enabled DHTs, helping you understand unique regulatory challenges, optimize evidence generation, and bring your products successfully to market.
Partner with us in an upcoming project
Project partners are critical to DiMe being able to develop clinical quality evidence on a rapid tech timeline. By being part of DiMe projects, organizations contribute to collaborative, open-science efforts lasting six to twenty four months, addressing a pressing challenge in the digital medicine space.