Achieve 80% cost reduction—from $25 to $5 per test—using the Mission® Cholesterol Meter, which delivers lab-accurate results in just 3 minutes. Boost patient follow-up by 60% while unlocking new revenue streams, and empower patients with immediate, accessible health insights. 

By 2025, medical device importers and distributors will face one of the most significant regulatory shifts in decades. The European Union's MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) deadlines are closing in, while the U.S.

QMSR will align FDA's medical device quality management system with ISO 13485:2016. It will be released by the end of this year and become effective one year later. This harmonization is expected to save medical device companies at least $439 million over the next decade.

With tightening EU regulations like MDR, IVDR, RoHS, and REACH, medical importers and distributors face growing compliance and supply chain risks. This article explores key impacts, actionable steps, and how working with Medasia ensures access to certified, cost-effective, and regulation-ready medical products.