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. 

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