Medical device companies selling into multiple countries don’t answer to one global regulator. They navigate a patchwork of national requirements that two organizations are trying to align in very different ways. 

The International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP) share the same broad goal, but their founding circumstances produced different ideas about who belongs at the table and how much control the table should have.

This is not an academic distinction. IMDRF is under new leadership and developing a “playbook” meant to make regulatory convergence more usable. Singapore, as the 2026 IMDRF chair with deep roots in both organizations, is well positioned to bridge them. What’s decided during the next year will likely determine whether manufacturers get a genuinely workable path to multiple markets or one more layer of requirements to manage on top of what they already navigate. 

The membership patterns of the IMDRF and the GHWP reveal deliberate choices about influence and control. The U.S. Food and Drug Administration has kept full management committee membership in IMDRF relatively limited. This structure helps maintain the FDA’s desired direction and preferred priorities, and prevents the IMDRF from drifting beyond them. Some regulators clearly prefer this tighter model.

GHWP, by contrast, has struggled with leadership over the past three years, and it’s unclear whether this will improve soon. This may have encouraged more regulators to engage with IMDRF as affiliate members.

As medical device companies sell into an ever-growing number of nations, industry continues to press for practical, adoptable regulatory approaches—whether those approaches originate in IMDRF documents or GHWP guidance. Medical device regulations remain among the mightiest technical barriers to trade, and when they go awry they become barriers to care.

It’s essential that regulatory convergence continues to advance. Without it, nations risk developing scores of divergent national requirements that threaten both trade and patient access to essential therapies—particularly those supplied by small and medium-size companies that can’t meet dozens of different demands.

Historical context

To understand what may come next, it’s useful to look at how these two organizations came into being and how they are managed.

The FDA helped create the Global Harmonization Task Force (GHTF) in 1992–1993 to try to align medical device regulations in different countries. Not long afterward, a group of committed regulatory affairs professionals (both regulators and industry representatives) from Asia-Pacific economies responded to the fact that most of Asia had been left out of GHTF. They formed the Asian Harmonization Working Party (AHWP, later rebranded GHWP). Because many early AHWP members came from less-developed economies, a noticeable difference emerged in how the two organizations framed new regulatory guidance. AHWP was far more concerned with the capacity constraints of smaller economies than the founding members of GHTF (U.S., Canada, EU, Australia, and Japan). This difference has shaped the approaches of both organizations ever since.

Because AHWP was a direct response to exclusion from GHTF, its embrace of smaller economies fueled enormous growth. Today GHWP includes medical device regulators from more than three times as many economies as the current IMDRF management committee.

The FDA ultimately ended GHTF and launched IMDRF. One major driver was the desire to remove industry from formal decision-making roles. Another was to establish the Medical Device Single Audit Program (MDSAP), which the FDA saw as a way to supplement its limited capacity to inspect manufacturers globally.

But GHWP never abandoned industry engagement. It has continued to draw on industry experts—many with deep connections to IEC/ISO technical committees and first-hand experience of regulatory friction. This has allowed GHWP to produce guidance that’s often more practical and less likely to create unnecessary trade barriers, while still addressing the patient-safety priorities of the regulators who lead the organization.

Current dynamics and critiques

More regulators than ever are looking to both organizations for harmonization support. However, the FDA’s influence over both GHTF and IMDRF has often been less supportive of the needs of developing nations. GHWP has generally been more accommodating in this regard.

China’s stated preference—“We are looking for win-win guidance from IMDRF to use at GHWP”—is sensible on its face. In practice, China largely defines what counts as “win-win,” and GHWP’s processes for assessing and implementing such guidance appear less focused on broad consensus.

Leadership in both organizations has at times shown limited willingness to adopt more democratized processes in which all members must vote and agree on published guidance. IMDRF achieves this largely by restricting who sits at the table; GHWP does so by limiting the use of strict procedural voting. When consensus is not achieved, regulatory convergence falls short. Ultimately, both IMDRF and GHWP guidance remain voluntary, even when members aspire to incorporate it into national regulations.

Example: FDA, MDSAP, and ASCA

A major priority for the FDA in creating IMDRF was the development of the MDSAP to address shortfalls in routine FDA inspections. By incorporating the requirements of five regulatory systems into a single audit, MDSAP managed to multiply both cost and complexity. To this day, the program remains relatively stagnant precisely because of that complexity and expense. It’s simply not suitable for widespread global use; smaller economies are effectively priced out and can’t participate without making the system even more costly and complex.

This is exactly why GHWP endorsed the International Accreditation Forum (IAF) initiative around ISO 13485 certification and worked to ensure regulators had free access to the IAF CertSearch database so they could quickly validate any certificate submitted as part of a regulatory clearance process. GHWP prioritizes solutions that protect patients while realistically addressing the capacity limitations that many regulatory authorities face.

A similar pattern appears in the FDA’s Accreditation Scheme for Conformity Assessment (ASCA). Although ASCA draws on tools of international accreditation, it deliberately stops short of fully leveraging third parties and widely accepted mutual recognition arrangements such as the ILAC MRA. Once again, an approach framed around international standards was narrowed to preserve FDA control.

Looking forward: The emerging framework

New leadership at IMDRF and work on a forthcoming “playbook” offer the best near-term chance for a more usable global framework. Expectations include:
• Stronger emphasis on MDSAP certification as a central element (driven in part by FDA priorities)
• Renewed focus on an updated set of Essential Principles of Safety and Performance. The EU, Switzerland, and UK already use a modern version; Canada and Australia still rely on an older edition and would likely be receptive to alignment.
• Greater attention to AI, informed by the EU AI Act and related European standards

There is a real risk that the planned regulatory playbook will miss opportunities to use internationally accredited ISO 13485 certificates that can be quickly checked for validity via IAF CertSearch.

On the positive side, many GHWP members already participate in IMDRF meetings as affiliates or observers. Singapore’s prominent role—both as 2026 IMDRF chair and through its long history of leadership within ASEAN and GHWP—could help build bridges and create more win-win scenarios for both organizations and for global medical device trade.

Never before has IMDRF been better positioned to drive meaningful regulatory change more quickly, with greater cooperation from GHWP members now affiliated with IMDRF. Critical constraints remain, however, around capacity building. Many GHWP members (and some IMDRF affiliates) will continue to struggle with overly sophisticated frameworks. Would a regulator in Pakistan be able to evaluate a complex AI-driven medical device? These are very real concerns. Patients need access to both basic care and sophisticated therapies.

While it’s unlikely that every nation can immediately implement complex solutions for complex devices, developing economies are rapidly building capability—and some, such as South Korea, are already leading globally in certain areas.

Whatever IMDRF produces will likely find a home in GHWP guidance. Solutions must nevertheless be designed so they can be tailored for smaller economies. Specific approaches should build on open international accreditation infrastructures rather than closed, high-cost programs. Public-health protection systems need effective regulatory convergence, or the therapies patients depend on will remain elusive.

GHWP vs. IMDRF membership and participation by country/region