A well-built regulatory strategy creates assets that can often be reused: intended purpose, device description, risk management, quality documentation, verification and validation, clinical or performance evidence, cybersecurity documentation and post-market data.
The question is what can travel, what needs to be adapted, and what has to be done again.
Start with the destination market, not your existing approval
A common mistake is to ask:
“We already have CE. How do we convert it to FDA?”
There usually is no direct conversion.
Instead, start by establishing the regulatory pathway in the new jurisdiction:
product → intended use → regulatory status → classification → market-access pathway → evidence requirements → local obligations
Then map what you already have against those requirements.
That identifies three categories:
Reusable
Work that can support the new submission substantially as it stands.
Adaptable
Work that is relevant but needs a different format, argument, endpoint or regulatory framing.
New
Requirements specific to the destination market.
This is usually much more efficient than building a second regulatory programme independently.
Build a reusable regulatory core
Across major medical-device markets, regulators are asking many of the same fundamental questions:
- What is the device?
- What is it intended to do?
- Who is it for?
- What are the risks?
- How was it designed and manufactured?
- Does it perform as intended?
- What evidence supports its safety and performance?
- How will it be monitored after launch?
The regulatory frameworks are different, but much of the underlying science and engineering does not change when the product crosses a border.
That means documentation such as the following may become valuable international regulatory assets:
- device description and architecture
- intended purpose or intended use
- design and development documentation
- risk-management files
- software documentation
- cybersecurity documentation
- usability evidence
- analytical and technical validation
- clinical or performance evidence
- manufacturing and supplier controls
- post-market evidence
The earlier international markets are considered, the easier it is to design these assets for reuse.
Europe, the United States and China
Europe
For the EU, start with the MDR or IVDR.
Establish:
- whether the product is a medical device or IVD
- its intended purpose
- classification
- applicable conformity assessment pathway
- Notified Body involvement
- evidence requirements
- economic-operator requirements
- UDI and EUDAMED obligations
A US or Chinese approval can provide useful evidence and regulatory history, but it does not replace the MDR or IVDR assessment.
The EU regulatory argument still needs to stand on its own.
United States
For the US, start with the FDA device classification and product databases and identify the appropriate regulatory pathway.
Depending on the device, this may involve:
- exemption from premarket submission
- a 510(k) based on substantial equivalence to a legally marketed predicate
- a De Novo request for a novel low- or moderate-risk device without an appropriate predicate
- Premarket Approval (PMA) for certain high-risk devices
The important question is therefore not simply whether the device already has CE marking.
It is how FDA regulates this type of device, for this intended use, with these claims.
Existing European verification, validation, risk and clinical evidence may still be highly valuable, but it needs to be assessed against the US regulatory question.
China
China has its own system of medical-device and IVD registration and filing administered by the National Medical Products Administration (NMPA).
Imported Class I devices are generally subject to filing, while imported Class II and III devices are subject to NMPA registration. Overseas applicants also need a domestic legal-person agent in China.
Existing international approvals and evidence may form part of the regulatory package, but China has its own registration requirements, documentation expectations and regulatory processes.
This is why China should not simply be treated as a translation project at the end of European product development.
Think internationally before you validate
Internationalisation becomes particularly important when expensive evidence is being generated.
Before commissioning a major validation or clinical study, ask:
- Which markets do we realistically expect to enter?
- Do those regulators expect similar endpoints?
- Can the same study population support more than one submission?
- Are there local requirements that should influence study design?
- Are we making claims that will create a substantially different pathway elsewhere?
- Can the validation protocol be designed so that the resulting evidence is reusable?
A small amount of international regulatory work before a study can avoid substantial duplication later.
International harmonisation helps, but it has limits
Medical-device regulators cooperate extensively through organisations such as the International Medical Device Regulators Forum (IMDRF).
There are also formal mechanisms for reducing duplication.
For example, the Medical Device Single Audit Program (MDSAP) allows one recognised audit to address relevant quality-system regulatory requirements across participating authorities including Australia, Brazil, Canada, Japan and the United States. The EU currently participates as an official observer rather than a full MDSAP member.
These initiatives make international regulatory strategy easier.
They do not create a single global approval.
Useful starting resources
You can investigate a substantial part of an international pathway yourself.
Useful primary sources include:
- European Commission medical-device pages for MDR, IVDR, MDCG guidance, EUDAMED and Notified Bodies
- FDA Device Classification Database
- FDA 510(k), De Novo and PMA databases
- NMPA and CMDE for Chinese registration rules, guidance and technical review
- IMDRF for internationally harmonised terminology and regulatory guidance
- MDSAP for international quality-system audit requirements
Start with the regulator, not with a consultancy blog.
Where Fabola comes in
The difficult part of internationalisation is rarely finding another country's regulations.
It is determining how the regulatory strategies relate to each other.
Fabola can help you:
- establish the regulatory pathway in each target market
- compare EU, US and Chinese requirements
- identify which existing evidence and documentation can be reused
- identify genuine regulatory gaps before commissioning new work
- align intended purpose, intended use and claims across markets
- design validation and evidence strategies with future markets in mind
- coordinate EU, US and China market-access planning
- work with local regulatory specialists where local execution is required
We particularly like getting involved before expensive evidence is generated.
The objective is not to create three separate regulatory projects for three markets.
It is to build one strong regulatory core and adapt it intelligently for each jurisdiction.