Entering the US and Europe: Key Authorization Questions to Address Before Translation
This article summarizes the starting points for entering the US and Europe before translating domestic authorization materials.
It provides a practical checklist to clarify product definitions, market pathways, grounds for holding, and additional tasks.
Confirm the Starting Point Even with Available Domestic Materials
When preparing for overseas expansion, the first step is to gather English technical documents and test results.
While these documents are essential assets, mere translation does not ensure compliance with the target market's requirements.
First, clarify what product will be claimed for which intended use and the pathway for market entry.
This article deals with the initial review of general medical devices and does not provide guidelines for specific submission materials or durations for each product.
The Review Path Differs Between the US and Europe
In the US, it is necessary to confirm whether the product qualifies as a medical device, its classification, and the premarket pathways applicable.
Given that there are various pathways like 510(k), De Novo, and PMA, it can be misleading to uniformly refer to all products as 'FDA certified' without identifying specific tasks.
In Europe, it is necessary to review the applicable regulations and conduct a conformity assessment based on the classification, which then leads to CE marking after fulfilling the required procedures.
It is also essential to differentiate between the applicable regulations for general medical devices and in vitro diagnostic medical devices.
| Initial Question | US Review Starting Point | European Review Starting Point |
|---|---|---|
| What is the product? | Intended use, regulation classification, product code | Intended purpose, applicable regulations, classification rules |
| What is the procedure? | Relevant premarket pathway including exemptions | Conformity assessment pathway and involvement of notification bodies |
| Can the materials be utilized? | Compliance with submission purpose, product composition, and test conditions | Compliance with applicable requirements, product composition, and scope of grounds |
This table lists initial review questions and does not represent classification results of individual products.
Classify Materials Based on Utilization Potential Rather Than Translation Status
Below are MedQraft's practical organizational suggestions.
For each certification, note not only the file name but also the evaluation model, version, conditions, issue date, and justifications that support the claims.
For example, if a sensor or software has changed after domestic evaluation, assess whether past reports apply to the new configuration.
A document with an English version alone does not qualify it for submission.
- Utilization Candidates: Materials verifying the range for utilization against target requirements.
- Additional Explanation Required: Materials needing explanations for product differences or test conditions.
- Additional Evaluation Review: Items hard to substantiate with current grounds.
- Uncertain: Items for which paths or claims haven’t been established.
Create a Material Discrepancy Review Table First
In meetings preparing for overseas expansion, simply stating “we have test data” makes it difficult to calculate remaining tasks.
To determine whether materials can be submitted, one must examine what claims and compositions are supported.
Below is an example of an internal review table, not a formal form.
| Review Item | What to Confirm from Existing Materials | Decisions to Make During Meetings |
|---|---|---|
| Product Composition | Model, accessories, software version, evaluation subjects | Who will review differences from the launch composition |
| Intended Use | Target population, users, environment, range of claims | Whether additional claims have been added from market-specific explanations |
| Performance Grounds | Test methods, conditions, evaluation criteria, results | Scope of utilization and supplementary review items |
| Labeling and Instructions | Cautions, restrictions, model-specific documentation | Person in charge of comparing with local requirements |
| Quality Operations | Manufacturing scope, outsourcing, and actual operation records | Tasks to be organized to meet local requirements |
For instance, if a hypothetical measuring device was evaluated for medical use in the country but intended for household sale abroad, the differences in users and environments should be included in the review checklist.
Do not prematurely decide to discard all old materials or reuse them entirely.
The order is to confirm the extent of the effects of differences and any additional grounds required.
What Should Remain After the Expansion Review Meeting
Do not conclude meetings with a simple decision like 'proceed to the US'.
It is more beneficial to maintain the bases for pathway judgment, unresolved questions, responsible parties, and materials needed for next decisions.
- Separate country-specific pathway candidates and their justifications.
Do not apply a judgment from one country directly to another market.
- Decide if additional evaluations are needed after reviewing product differences and requirements.
- Document prerequisites for estimates and schedules.
If product composition or range of claims changes, specify what needs reassessment.
- Assign work related to preparation for permits and conformity assessments, as well as post-launch quality operations together.
If there is insufficient material to finalize the pathway, manage that as an unresolved item.
It is important not to treat uncertain items in the timeline as confirmed stages.
Include Judgment Points in the Schedule
A timeline containing only ‘translation, submission, sales’ does not reveal the causes for rework.
It is advisable to treat establishing product definitions, reviewing material discrepancies, making additional evaluation decisions, and preparing quality systems as separate tasks.
The US QMSR will be enforced from February 2, 2026, and will reference ISO 13485:2016.
When using previous preparation lists, it is necessary to verify differences from current regulations.
In the first meeting, bring what is confirmed among the current product composition and held grounds, along with target countries and timelines.
MedQraft collaborates on reviewing the scope of permits and quality tasks based on this material.
This document is based on publicly available materials confirmed on September 11, 2026, and practical suggestions.
Specific regulatory applications, exceptions, and submission requirements must be verified separately.
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