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Q: Morning all. If you want international regulatory clearance for a new product, is it still best to follow the 510(k) framework first? About 15 years ago we were advised that it was the most prescriptive route and would cover most requirements for Europe, Australia, Canada, and others. Is that still true, or is there now a better approach to avoid repeating work when expanding to new markets?
That’s a really good question, and one we hear quite often. The US 510(k) route was once seen as a useful reference point for companies aiming for global market access, but the regulatory environment has evolved considerably.
The US 510(k) process focuses on showing that a new device is substantially equivalent to one already on the market, which makes it a structured and relatively predictable pathway for clearance within the US. However, this focus on equivalence does not fully align with the direction other regulators have taken. The EU and UK now place greater emphasis on demonstrating independent clinical evidence, maintaining ongoing post-market surveillance, and managing risk throughout the device lifecycle. There remains significant overlap in principles such as design control, risk management, and quality assurance, but the 510(k) approach alone no longer captures all expectations for international clearance. Other key markets, such as Australia and Canada, share many of these underlying principles. Australia is more closely aligned with the EU system, while Canada maintains its own conformity assessment framework.
The most effective approach today is to establish a clear regulatory strategy at the outset. A well-considered strategy looks across multiple jurisdictions, identifies where requirements align, and plans evidence generation and documentation so that each new market builds on the last. This helps avoid unnecessary repetition and supports efficient, compliant international expansion.
Many Medilink members tell us their biggest challenge is simply navigating the complexity of evolving regulations, especially when guidance feels open to interpretation.
From your experience at Sotas, what practical steps can smaller medtech or life sciences companies take to stay compliant without stalling innovation or burning through limited resources?
You’re right that navigating evolving compliance requirements can be difficult, particularly for smaller organisations without dedicated compliance teams. From our experience at Sotas, the most effective approach is to make compliance a strategic enabler rather than a constraint.
Start with proportionality.
Begin with a lean Quality Management System aligned to ISO 13485 and expand it as your development and regulatory activities grow. Keep the system simple, structured, and reflective of how your team actually works day to day. When compliance becomes part of normal activity rather than a separate process, it supports innovation instead of slowing it down.Develop a clear regulatory strategy early.
This is often the most important step. A well-defined regulatory strategy helps align regulatory planning with business direction, clarifying target markets, clinical evidence requirements, and the pathway to approval. It ensures that innovation, funding, and compliance all move in the same direction.Anchor decisions in documented rationale.
Regulators look for traceability and logic. When your key choices are risk-based and well justified, you demonstrate control and understanding, even where guidance is open to interpretation.Use standards and selective expertise to accelerate progress.
Standards provide ready-made frameworks, and focused external input at key points can save time and uncertainty.Compliance should be seen as a tool that helps innovative ideas reach patients safely and sustainably.
