WHO, 12 November 2025 — The World Health Organization (WHO) has released the second edition of its influential publication, Development of Medical Device Policies, marking a pivotal update in global health governance. Designed to support national health systems, this document outlines comprehensive policy frameworks for medical devices from innovation and regulation to sustainability and lifecycle management. For medical device manufacturers, the message is clear: the global playing field is evolving, and aligning with WHO’s new guidelines is no longer optional, it’s strategic.
WHAT’S NEW IN THIS EDITION?
Building on its 2011 predecessor, the 2025 edition introduces critical updates aligned with the Sustainable Development Goals (SDGs) and lessons learned from the COVID-19 pandemic. It tackles modern challenges like digital health, AI-driven devices, participatory governance, and climate-conscious manufacturing.
WHAT DOES IT MEAN FOR MANUFACTURERS?
1. Regulatory Readiness Is Non-Negotiable
Manufacturers are expected to comply with globally harmonized regulatory frameworks such as the WHO Global Model Regulatory Framework and participate in audit programs like MDSAP.
2. Health Technology Assessments (HTAs) Influence Market Entry
Devices must demonstrate more than clinical safety — cost-effectiveness, public health relevance, and equity in access are now prerequisites for inclusion in national health systems.
3. Sustainability and Lifecycle Design Are Front and Center
The WHO encourages governments to adopt procurement models that reward eco-friendly, reusable, and locally serviceable devices.
4. Digital Health, AI & Cybersecurity Are Under Scrutiny
The report defines new expectations for software-based devices, including AI, with attention to cybersecurity, data privacy, and ethical algorithms.
5. Policy Engagement Is Now a Strategic Advantage
Governments are urged to include manufacturers in policymaking through multi-stakeholder engagement
WHAT SHOULD MANUFACTURERS DO NOW?
- Map your product portfolio to WHO’s priority device lists.
- Align practices with GMDN/EMDN and UDI standards.
- Invest in HTA evidence generation.
- Implement sustainability strategies.
- Support reliance and recognition models.
WHO FINAL SUMMARY
The WHO emphasizes that 46% of countries still lack a comprehensive medical device policy. This guidance provides a roadmap to ensure devices are safe, equitable, cost-effective, and sustainable. Manufacturers that align early will not only comply they will compete better, partner deeper, and grow stronger in tomorrow’s global health landscape.
📘 Download the full WHO report: Development of Medical Device Policies – 2nd Edition (PDF)