Abstract

In February 2026, the US Food and Drug Administration’s Quality Management System Regulation (QMSR) took effect, replacing the Quality System Regulation that had governed medical device manufacturing since 1997 and bringing the international quality management standard for medical devices under US federal law. For manufacturers already operating certified quality management systems, this could look like the moment the US joined the international mainstream, and the moment a single global quality system became achievable.

This article argues that convergence is real and valuable, but that it should not be mistaken for regulatory equivalence. Adopting a common standard is not the same as adopting a common regulatory system; legal status, definitions, reporting obligations, oversight mechanisms and enforcement powers all remain national. Using the US as a worked example, the article examines what still differs once the standard is shared, why third-party certification is not evidence of compliance with US federal requirements, and how a manufacturer selling the same device in several markets can avoid both the cost of duplicated national systems and the quieter risk of a generic system that misses local law. It proposes a practical model: harmonise the core, identify the differences, integrate them deliberately and control them continuously.