In a recent IPM Perspective, my colleague Kristin Kinscherff made a compelling case that the traditional “FDA-first” strategy is becoming outdated for life sciences companies competing in global markets. Sequential regulatory submissions may reduce near-term risk, but they can also slow market access, strain teams, and limit global opportunity.
For US-based MedTech companies, that same shift is becoming increasingly relevant as global regulatory harmonization gains momentum.
For years, harmonization has sounded like an attractive promise. The pitch is fewer duplicative submissions, more consistent evidence expectations, lighter audit burden, and faster access to global markets. That promise now feels more tangible. FDA’s Center for Devices and Radiological Health has made international harmonization, convergence, and reliance a formal strategic priority. Harmonization aligns standards, convergence aligns processes and expectations, and reliance lets one authority build on another’s assessment. The International Medical Device Regulators Forum (IMDRF) continues to align regulators around quality management systems, software as a medical device, AI-enabled technologies, adverse event terminology, and regulated product submissions.
Realities and Risks
The question is whether these efforts will produce meaningful change. My view is yes, but unevenly.
Harmonization is already real in areas where regulators can align on standards and processes without surrendering local authority. For instance, FDA’s Quality Management System Regulation, effective February 2, 2026, incorporates ISO 13485:2016 and aligns FDA’s device CGMP framework with quality system requirements that other regulatory authorities use. MDSAP (Medical Device Single Audit Program) is another practical example. A single audit can satisfy relevant requirements of several jurisdictions, currently Australia, Brazil, Canada, Japan, and the United States, though uptake is uneven across them and EU still an observer.
Don’t mistake harmonization for a single global approval pathway. Each authority still makes its own decisions, reflects its own statutory obligations, and responds to local public-health priorities. The EU, for example, continues to refine implementation of MDR and IVDR through new rules, guidance, and conformity assessment requirements. China’s NMPA remains a largely separate track with its own testing and registration expectations. For US MedTech companies, convergence may reduce friction, but it won’t eliminate the need for region-specific regulatory strategy.
If done well, these changes could improve how MedTech companies design and introduce products globally. Standardized expectations will let teams build global evidence packages earlier, improve submission quality, and reduce rework. Two FDA programs point the same way, even if neither is harmonization in the strict sense. FDA’s eSTAR program standardizes 510(k) and De Novo submissions, and its shared template with Health Canada gives it a cross-border dimension. And FDA’s TAP Pilot pushes a lifecycle mindset through earlier and more frequent engagement for certain innovative devices. Both reward companies that plan for structure and engagement early.
Look Beyond Regulatory
A potential risk is that companies treat harmonization as a regulatory affairs project rather than an enterprise operating-model change. In my conversations with MedTech regulatory leaders, the challenge is rarely the regulation itself. It is how organizations interpret and operationalize quality systems, governance, approvals, and cross-functional handoffs. Harmonized external expectations don’t help much if internal decisions and data flows are still built market by market.
So, what should US MedTech companies be thinking about now?
- First, build a global regulatory strategy, so evidence planning, human factors, cybersecurity, software, and AI governance are worked once for global reuse rather than market by market after design freeze.
- Second, treat QMSR readiness as an opportunity to strengthen the quality system, not just update documentation.
- Third, stand up governance that connects R&D, quality, regulatory, clinical, operations, and commercial early in the product lifecycle, with clear ownership of the handoffs that usually break.
Harmonization won’t remove the complexity from MedTech product development. But it will reward companies that are disciplined, integrated, and proactive. The advantage will go to those that redesign their development and quality systems to move faster inside a more aligned but still highly accountable environment, not to those who wait for regulators to make the process easier.
August 7, 2026
