The Regulatory Passport Is Changing: Is Your Market Access Strategy Changing With It?
by Colm O’Rourke, Quality & Regulatory Consultant and Trainer
For years, global MedTech market access followed a relatively familiar path. CE marking was often secured early and used as a foundation for expansion into other international markets, while FDA approval progressed in parallel for access to the US.
That path still matters, and the CE mark remains a critically important global approval. But the assumptions around it are changing.
As international regulatory reliance grows, manufacturers increasingly have more than one trusted approval pathway that can support access to other markets. That creates more choice around which approval comes first, which markets can follow, what can run in parallel and what evidence needs to be prepared earlier.
To me, that is where the conversation becomes much more strategic. Regulatory reliance is not simply an efficiency story. It has the potential to change how manufacturers architect their global route to market.
Harmonisation creates the foundation for reliance
Regulatory harmonisation and regulatory reliance are related, but they are not the same thing.
Harmonisation is about bringing the underlying regulatory concepts and requirements closer together. Areas such as device classification, clinical evidence, conformity assessment and unique device identification need enough commonality for one regulator to understand and trust the work performed by another.
Reliance builds on that foundation. It allows a regulator to use an approval or assessment from a trusted overseas authority as part of its own route to market, while still applying local requirements where needed.
Australia is a useful example. The TGA accepts a range of comparable overseas approvals to support Australian market access. It is not a free pass and local requirements still apply, but it shows what becomes possible when regulators have enough confidence in one another’s systems.
The strategic implication for manufacturers is straightforward: as regulators become more connected, market access strategy needs to become more connected too. Does that require a change in mindset, process, skills – or all three?
The “international passport” is no longer a single assumption
Historically, CE marking often acted as the international passport into many secondary markets. At the same time, the FDA was seen as a more difficult and less predictable route, so many companies built their regulatory plans around CE first and FDA in parallel.
Over the past decade, that balance has shifted. FDA pathways have become more predictable in many cases, while MDR has made CE marking more complex, time-consuming and costly for many manufacturers. As a result, some companies now pursue FDA first and consider Europe later.
That matters because other regulators are broadening the approvals they are prepared to rely on. If a manufacturer expects FDA approval well ahead of CE marking, the question is no longer simply whether that gets the product into the US sooner. It becomes: what else can that approval unlock? Could another market be entered earlier? Could submissions be sequenced differently? Could some pathways progress in parallel? Could the first approval create an opportunity to gain market experience somewhere that previously would have waited for CE marking?
This is the mindset shift I think manufacturers need to keep exploring. Global Regulatory strategy should not be built around the assumption that yesterday’s sequence will always be tomorrow’s best route.
Reliance makes earlier Regulatory strategy even more organisationally important
One of the most important consequences is that Regulatory strategy needs to start earlier.
If you know which market you intend to enter first, and which approval you plan to leverage elsewhere, that decision can shape clinical evidence strategy, claims, documentation, resource allocation and product-development choices long before the submission itself begins.
A practical example is Australia. If a manufacturer intends to leverage FDA clearance to support Australian market access, it may need to prepare evidence or documentation earlier than it would have if those activities were being left for a later CE-marking process.
That is why reliance should not be viewed simply as a way to reduce duplicated submission work. Used well, it can encourage better planning across the whole development and market-access pathway.
The question for Regulatory Affairs becomes less ‘What do we need for the next country?’ and more ‘What is the global route, what will the first approval unlock, and what do we need to build now to make that strategy work?’
Does that mean Regulatory Affairs needs to be brought further upstream into product, evidence and market strategy?Can we build on what the industry already knows?
Agility may become part of Regulatory capability
There is also an organisational dimension to this.
Startups and smaller organisations can sometimes change direction more quickly. Their Regulatory strategy still needs to be disciplined, but if a new market opportunity emerges or a reliance pathway changes, they may be able to adjust the plan while the programme is still moving.
For large, established MedTech organisations, the picture can be different. They have deeper resources, experience and local market knowledge, but they can also have more fixed processes. If the conversation about leveraging reliance only happens halfway through a product programme, it may already be difficult to change course.
That creates an interesting challenge for established manufacturers: how do you combine the scale and expertise of a large organisation with the ability to rethink market sequencing when the regulatory landscape changes?
I do not think there is one structural answer. But I do think the organisations that build Regulatory strategy into early commercial, clinical and product-development discussions will be better placed to recognise options before they become too late to use.
The real purpose is access, rather than efficiency
It is easy to talk about regulatory reliance mainly in terms of reducing duplicated work. There is a regulator resource benefit, and there can be a manufacturer efficiency benefit, but I think the more important outcome is patient access.
For smaller markets in particular, every unique regulatory hurdle can influence whether a manufacturer decides that market is commercially viable. If a trusted approval from another jurisdiction can be used appropriately, while the local regulator retains the safeguards it needs, that can make access to innovative devices more achievable.
This is not about lowering standards. It is about avoiding unnecessary reinvention where confidence can be maintained through trusted regulatory systems.
When reliance works well, there is a potential benefit for all sides: regulators can focus resources where they add most value, manufacturers can make smarter decisions about routes to market, and patients can gain earlier access to innovation.
If trusted approvals can help patients access innovation sooner without lowering standards, how much duplication is still justified?
A different Regulatory conversation
International reliance will continue to evolve. Local requirements will remain. CE marking will continue to be a major global approval. FDA pathways will not suit every device or every strategy.
But the direction of travel is enough to challenge old assumptions.
The most useful questions for manufacturers may no longer be limited to which submission comes next. They may be: Which approval gives us the greatest strategic optionality? Which markets could it unlock? What evidence should we start building now? And are our teams and processes agile enough to change course when the opportunity emerges?
These are the conversations we at Trinzo are continuously exploring with our clients as we stay abreast of developments around convergence, harmonisation and reliance. Because as regulatory systems become more connected, the opportunity for manufacturers may not simply be to do the same things faster. It may be to think differently about the route to market altogether.
