By GARR Staff
November 10, 2025
If you stepped into your bathroom this morning and hopped on a scale, brushed your teeth, or unwrapped dental floss, you already interacted with three medical devices—before even starting your day. Medical devices are embedded in daily life so deeply that we rarely stop to think of them as regulated products. Yet when crisis hits—like the COVID-19 pandemic—we suddenly realize just how essential they are. Syringes, masks, respirators, gloves, ventilators, and diagnostic tools weren’t just helpful during COVID-19; they were essential to global survival.
The pandemic exposed glaring gaps in how quickly medical devices can reach the people who need them. It also sparked an important question: How can countries work together so life-saving devices move faster, smarter, and more equitably across borders—without compromising safety?
One promising answer is a concept called Regulatory Reliance.
What Is Regulatory Reliance—and Why Should We Care?
Regulatory reliance is simple in theory but transformative in practice. WHO championed reliance as a cornerstone of “smart regulation” through Good Regulatory Practices and Good Reliance Practices which were first introduced in 2021. The World Health Organization (WHO) defines it as:
‘A process where one regulatory authority uses the assessments or decisions of another trusted authority to inform its own decisions—while still acting independently’ (WHO, 2021)
In other words: no need to reinvent the wheel. If a trusted regulator has already inspected a factory or evaluated a device’s safety, another regulator can use that work as part of their own assessment. This doesn’t mean giving up sovereignty or lowering standards. Instead, it means:
- Faster access to safe, effective devices
- Better use of limited staff and resources
- Less duplication and bureaucratic delay
- Stronger health systems in low-resource settings
And researchers agree that reliance is one of the most promising pathways for accelerating patient access to high-quality medicines and medical devices. “Regulatory reliance facilitates regulatory approvals and allows to use resources in a more efficient way and ultimately serves patients by facilitating earlier access to quality-assured, safe, and effective medicines” (Doerr et al., 2021). “The COVID-19 pandemic highlighted the value of regulatory reliance to enable easier access to medical devices that have gone through regulatory approvals in countries with mature regulatory systems” (Xu et al., 2022).
Why Reliance Matters for Social Determinants of Health
It may seem like a technical regulatory tool, but its impact is anything but small. Reliance touches many Social Determinants of Health (SDoH), including:
- Access to Healthcare : If it takes years for a medical device to be approved in a low-resource country, patients simply don’t get the care they need. Reliance aims to shorten that timeline.
- Economic Stability: Countries with small or overstretched regulatory agencies spend less time duplicating assessments—and more time strengthening essential health infrastructure.
- Health Equity: Reliance helps reduce global disparities in which patients get access to modern, safe technology, no matter where they live, by leveraging assessments of trusted partner regulators.
Put simply: regulatory reliance is a lever for fairness and global health equity.
Collective Impact: Why Reliance Works Best Together
Regulatory reliance aligns perfectly with the five pillars of collective impact; A Common Agenda, Shared Measurement, Mutually Reinforcing Activities, Continuous Communication, and Backbone Support
1. A Common Agenda : Everyone—regulators, industry, WHO, IMDRF—share the same goal: safe, timely access to medical devices.
2. Shared Measurement: WHO and IMDRF have guiding principles and tools to help countries track progress and adopt common approaches.
3. Mutually Reinforcing Activities: Mature regulators provide assessments; emerging regulators use them to build capacity; industry benefits from clearer pathways.
4. Continuous Communication: IMDRF convenes global regulators twice a year to collaborate, compare challenges, and share solutions.
5. Backbone Support: WHO and IMDRF are organizations that act as the infrastructure—offering guidance, best practices, and coordination.
Reliance isn’t just a regulatory shift—it’s a collaborative movement.
The Challenges: Mindsets, Laws, and Trust
Even with its benefits, reliance isn’t always easy to implement and the challenges below are real;.
A Shift in Mindset Needed
Some regulators worry that using another authority’s assessment means giving up control. But reliance is not recognition; countries still make their own decisions.
Legal and Policy Barriers
Some national laws simply don’t allow reliance yet, requiring reforms or new frameworks.
Cultural and Institutional Resistance
Regulatory systems have long-established processes and may struggle to adopt new models.
Information-Sharing and IP Concerns
Manufacturers may hesitate to share proprietary data across borders, complicating reliance agreements.
These challenges highlight a need for continued research, particularly on how regulators make adoption decisions and how trust can be strengthened across agencies.
The Ethical Imperative
At its core, regulatory reliance is about people. The ethical considerations include:
- Ensuring all countries, especially low-resource ones—have an equal voice
- Respecting sovereignty while maximizing collaboration
- Supporting transparency and trust between regulators
- Understanding industry concerns around intellectual property and innovation
- Promoting equitable patient access globally
Ethical reliance isn’t about “fast approvals at all costs.” It’s about smart approvals with collective benefits.
Looking Ahead: A Path Toward Global Equity
The pandemic taught us that no country is truly independent when it comes to public health. Our ability to respond to emergencies—and to maintain routine healthcare—depends on how quickly safe, effective medical devices reach patients everywhere. Most importantly, regulatory reliance is a mechanism for meaningful social change and collective impact.
If implemented thoughtfully and consistently, reliance can help build a future where geography no longer determines the quality or safety of a patient’s care. In a world connected by shared challenges and shared solutions, regulatory reliance may be one of the most powerful tools we have.
Regulatory reliance isn’t a shortcut.
It’s a strategy.
A tool for smarter regulation.
A bridge between countries.
References
- Doerr, P., Valentin, M., Nakashima, N., Orphanos, N., Santos, G., Balkamos, G., & Saint-Raymond, A. (2021). Reliance: a smarter way of regulating medical products – The IPRP survey. Expert review of clinical pharmacology, 14(2), 173–177. https://doi.org/10.1080/17512433.2021.1865798
- World Health Organization (WHO). (2021). WHO good reliance practices: Guideline for national regulatory authorities for medical products. https://www.who.int/publications/i/item/9789240020592
- World Health Organization (WHO). WHO expert committee on specifications for pharmaceutical preparations: fifty-fifth report (WHO Technical Report Series, No. 1033). Annex 10 – good reliance practices in the regulation of medical products: high-level principles and considerations, 2022. Available: https://apps.who.int/iris/bitstream/handle/10665/340323/
- World Health Organization (WHO). (2023, May). Technical Briefing Seminar 2023. Geneva: World Health Organization www.who.int: https://www.who.int/news- oom/events/detail/2023/05/08/default-calendar/technical-briefing-seminar-may-2023
- Xu, M., Zhang, L., Feng, X., Zhang, Z., & Huang, Y. (2022). Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific. BMJ global health, 7(8), e009798. https://doi.org/10.1136/bmjgh-2022-009798