display:none
Skip to main content

Join FDA and DiMe during a 2-day virtual event to help advance the use of PGHD to support improved trials, medical device development products, and regulatory science!

Join the Virtual First Care Coalition to shape a healthcare system that's intentionally designed with patients at the center.

Assessing clinical evidence regulatory requirements across Asia Pacific, Europe, and North America

Digital health product commercial strategies should not be constrained to a single market in this economy. Global go-to market strategies are necessary for companies to benefit from expanded market reach, patient impact, competitive advantage, fostered innovation and knowledge, and improved financial performance. 

International Regulatory Pathways builds on the success of the Digital Health US Regulatory Pathways work to contemplate the global market by combining the expertise of global leaders from across the digital health product industry to foster innovation, drive progress, and harmonize regulatory efforts across Asia Pacific, Europe, and North America. This global project team brings diverse backgrounds and perspectives, essential for harmonizing the field.

Stay up to date on DiMe’s regulatory work


The project team will…

Conduct thorough evaluations of the regulatory landscapes and clinical evidence requirements in key global markets and identify obstacles and opportunities

Analyze and compare global regulations pertaining to digital health products, offering valuable insights to product developers to include their evidence generation and global go-to market strategy

Propel digital health products to reshape the global healthcare industry by outlining how to navigate complex international regulations to enable compliance and success on a global scale

Actively engage with regulatory authorities to accelerate time to market and decrease evidence collection and global go-to market costs

Project Partners

DiMe’s new 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 product (DHP) industry to foster innovation, drive progress, and harmonize regulatory efforts.

Are you working in the US? Check out DiMe’s Resources in US Regulatory Pathways

Course

Unlocking Regulatory Success for Digital Health Product Developers

Tool

Regulatory Strategy for Digital Health Products in the U.S.

Tool

Risk Assessment Model for Digital Health Product Lifecycle

Join our next project

Help streamline the path to regulatory and commercial success to optimize health outcomes for the greatest number of patients

Join the Integrated Evidence Plans project

Join us
Not today