Overview
For global medical device manufacturers, regulatory submissions often contain information created in multiple languages, formats, and locations. When that information must be submitted to the U.S. Food and Drug Administration (FDA), translation becomes more than a language exercise. It becomes part of the submission workflow.
FDA guidance and submission materials establish requirements and recommendations around English translations of foreign-language documents, document quality, and the accuracy and usability of submitted information. For regulatory teams, the challenge is ensuring that translated content preserves the original meaning while remaining consistent, traceable, and usable throughout the submission process.
That is why effective regulatory translations require more than linguistic accuracy. They require subject matter expertise, controlled terminology, document preparation, quality assurance, and a workflow designed around the needs of regulatory teams.
What Does the FDA Expect from Translated Documents?
The specific translation requirements can vary depending on the type of submission or information being provided to the FDA. However, FDA materials consistently emphasize the importance of accurate English translations when documents or records are maintained in another language.
For example, FDA submission guidance for medical device-related materials states that English translations should accompany foreign-language documents. FDA also recommends that submitted documents be accessible and usable for review, including verifying the accuracy and legibility of scanned documents and the accuracy of optical character recognition (OCR) when scanned materials are used.
For certain medical device submissions, the FDA requires electronic submission formats and structured submission processes. The increasing use of electronic submission tools makes document preparation and quality increasingly important alongside the translation itself.
The practical takeaway is straightforward: a translated document needs to be accurate, but it also needs to arrive in a form that supports efficient regulatory review.
This distinction is important when evaluating regulatory translations. The goal is not simply to produce English text. The goal is to preserve the information, context, terminology, and document integrity that regulators need to evaluate the submission.
Why Regulatory Translations Require More Than Literal Accuracy
Regulatory content is highly specialized. A seemingly minor change in terminology can affect how a safety statement, clinical finding, device specification, or technical requirement is interpreted.
Literal translation can, therefore, create problems even when every sentence appears grammatically correct.
Consider a medical device submission containing clinical reports, technical documentation, safety information, or labeling. The same component, clinical concept, adverse event, or technical term may appear repeatedly across multiple documents. If terminology changes from one translation to another, reviewers may have to determine whether two different terms describe the same concept.
Consistent terminology helps eliminate that uncertainty.
Experienced regulatory translation workflows typically incorporate approved glossaries, terminology databases, translation memories, subject matter expertise, and multiple levels of review. Morningside uses client-specific glossaries, Translation Memory, subject matter expertise, and multi-tier linguistic review as part of its life sciences translation processes.
For regulatory teams, this consistency becomes particularly important when submissions span multiple document types or multiple phases of a product’s lifecycle.
Regulatory Translations Must Preserve Document Context
Translation does not happen in isolation. Regulatory documents may contain tables, figures, annotations, abbreviations, references, footnotes, handwritten notes, redactions, signatures, and other elements that carry important information. A translation workflow that focuses only on extracting and translating text can overlook the significance of these elements.
FDA’s submission recommendations specifically address document usability. For example, the FDA recommends that scanned documents be checked for legibility and that OCR accuracy be verified. FDA also recommends providing English translations for foreign-language documents and creating glossaries or explanations for abbreviations, acronyms, jargon, and internal names in certain submission contexts.
This means document preparation can be an important part of regulatory translations.
Before translation begins, teams may need to determine:
- Which files actually require translation
- Whether source documents are complete and legible
- Whether scanned documents require OCR
- Whether handwritten content can be interpreted
- Which annotations or redactions need to be preserved
- Whether tables and figures require additional formatting
- Which abbreviations or internal terminology require clarification
- Whether duplicate or outdated documents have entered the workflow
Addressing these questions before linguistic work begins can reduce unnecessary rework later.
Quality Assurance Is Part of the Translation Workflow
For high-stakes regulatory content, quality assurance cannot be limited to proofreading the final English text. A robust workflow considers quality throughout the project. This can include terminology checks, linguistic review, formatting review, source-to-target comparison, document completeness checks, and project-level quality controls.
For medical device translation, this is particularly important because regulatory documentation can contain highly technical information where consistency and precision are essential. Morningside’s medical device translation processes incorporate ISO 13485-, ISO 9001-, and ISO 17100-backed processes and controls, alongside a three-tier linguistic review process.
The objective is not to add unnecessary layers to the process. It is to identify potential problems before they reach the final submission.
That distinction matters when managing regulatory translations at scale. A quality process should help teams identify missing information, terminology inconsistencies, formatting issues, and other potential problems early enough to address them without disrupting the submission timeline.
Managing Difficult Source Documents Without Slowing the Submission
Regulatory teams do not always receive clean, editable source files. Clinical and technical documentation can arrive as scanned PDFs, image-based files, handwritten records, spreadsheets, reports, or collections of documents assembled from multiple sources. This creates a second challenge: determining what should be translated and how the source material should be prepared before translation begins.
A strong workflow starts with document assessment and triage.
Files can be reviewed for completeness, readability, language, duplication, and translation requirements. OCR can be applied where appropriate, while source content that cannot be reliably extracted can be flagged for additional review. This is particularly valuable during large or unexpected regulatory projects.
In one Morningside case study, a global medical device company faced an unexpected FDA safety alert and needed nearly one million words of clinical content translated. Morningside’s project team created a file-tracking system aligned with the FDA submission phases, cross-checked incoming batches against the master list, and flagged missing or extraneous files before they created larger problems.
The lesson extends beyond that individual project: translation capacity alone does not solve complex submissions. The surrounding workflow matters as much.
Regulatory Translations Need a Workflow Built Around the Submission
The most effective approach is to treat translation as one component of a larger regulatory workflow rather than an isolated vendor handoff.
That means establishing clear processes for:
Document intake: Identify the files, languages, document types, and required delivery dates.
Source review: Assess document quality, completeness, formatting, OCR requirements, and potential issues before translation begins.
Terminology management: Establish approved terminology and maintain consistency across documents and project phases.
Translation and review: Assign qualified linguists and subject matter experts according to the technical and regulatory requirements of the content.
Quality assurance: Conduct linguistic, terminology, formatting, and completeness checks before delivery.
Change management: Maintain visibility when source documents change or new information is introduced during the submission process.
Final delivery: Ensure translated files are complete, correctly formatted, and ready for the next stage of the regulatory workflow.
Morningside’s regulatory translation services support documentation, including Instructions for Use, labeling, dossiers, validation documents, and other regulatory materials, across the product lifecycle. This integrated approach helps regulatory teams move from “getting documents translated” toward managing translation as a controlled part of submission readiness.
Regulatory Translations Should Support the Entire Product Lifecycle
FDA submissions are only one part of a medical device’s regulatory journey. Manufacturers may also need to manage clinical documentation, labeling, Instructions for Use, post-market information, and regulatory content for other markets. A translation strategy that accounts for terminology and document history across the product lifecycle can make future updates easier to manage.
For medical device companies operating globally, that can mean coordinating regulatory translation requirements across the FDA, the EU MDR and IVDR, and other regulatory environments.
Morningside supports medical device manufacturers with translation throughout the product lifecycle, including regulatory documentation, labeling, UDI and CE marking requirements, 510(k) submissions, and other global medical device translation needs.
Maintaining consistency across these activities can reduce duplicated work and give regulatory teams greater control over multilingual content as products move from development and submission through commercialization and post-market activities.
What to Look for in a Regulatory Translation Partner
Choosing a provider for regulatory translations requires more than evaluating language coverage or turnaround time.
Regulatory teams should consider whether a translation partner can demonstrate:
- Experience with medical devices and life sciences documentation
- Subject matter expertise in relevant therapeutic and technical areas
- Knowledge of regulatory requirements across target markets
- Structured terminology management
- Document preparation and OCR capabilities
- Quality assurance processes appropriate for regulated content
- Secure technology and data-handling practices
- Scalability for large or unexpected submissions
- Project management capable of coordinating complex, changing workflows
- Experience supporting submissions under tight deadlines
The right partner should function as an extension of the regulatory workflow rather than simply receiving files and returning translated documents.
Frequently Asked Questions
Q: What are regulatory translations?
Regulatory translations are translations of documents used to support regulatory activities, submissions, approvals, compliance, and post-market requirements. In life sciences, these may include labeling, Instructions for Use, dossiers, clinical documentation, validation documents, and other regulatory materials.
Q: Does FDA require English translations of foreign-language documents?
Requirements depend on the type of submission or record involved. FDA materials establish English-language translation requirements or expectations for various types of regulatory information. For example, FDA medical device submission guidance states that English translations in relevant submission contexts should accompany foreign-language documents.
Q: What makes a regulatory translation different from a standard medical translation?
Regulatory translations require consideration of regulatory terminology, document context, submission requirements, terminology consistency, formatting, quality controls, and traceability in addition to linguistic accuracy.
Q: Can scanned or handwritten documents be translated for an FDA submission?
They can be incorporated into a translation workflow, but the source material may require additional preparation or review. The FDA recommends verifying the accuracy of OCR and the legibility of scanned documents submitted in relevant contexts.
Q: Why is terminology consistency important in regulatory translations?
Consistent terminology helps preserve the meaning of technical, clinical, and safety information across documents. It can also make large submissions easier to review by reducing ambiguity and ensuring that recurring concepts are represented consistently.
Preparing for a Submission-Ready Regulatory Translation Workflow
Regulatory translations are an important part of preparing multilingual information for FDA submissions and other regulated activities. The objective is not simply to convert foreign-language content into English. Effective regulatory translation preserves meaning, terminology, context, document integrity, and quality throughout the submission workflow.
For medical device manufacturers, this requires a structured approach that begins with source-document assessment and continues through terminology management, expert translation, quality assurance, and final delivery. When these activities are coordinated early, regulatory teams can reduce avoidable rework and maintain greater visibility as submission requirements and documentation evolve.
As regulatory programs become increasingly complex and global, translation should be treated as part of submission planning rather than an activity added at the end of the process.
For a practical look at how regulatory teams can prepare for complex translation projects, download Morningside’s Regulatory Translation Playbook: How to Avoid FDA Delays and Protect Market Access.
Supporting Life Science Teams Around the Globe
Morningside, a Questel company, provides language solutions for life sciences organizations across regulatory, clinical, commercial, and other specialized content. With more than 20 years of life sciences experience, Morningside supports pharmaceutical, biotechnology, medical device, and healthcare organizations with specialized translation and localization workflows.
Our regulatory translation services combine subject-matter expertise, quality processes, terminology management, and technology-enabled workflows to help organizations manage multilingual content throughout the product lifecycle, from development and submission to commercialization and post-market activities.
Anna Eisenberg is the Director of Life Science Business Development at Morningside, with 20+ years of experience in the localization industry and a focus on life sciences. She is responsible for Morningside's life science strategy and maintaining relationships with global leaders in the field. Anna expertly advises pharmaceutical and medical device companies on best translation practices and is an expert in implementing workflows that improve quality, reduce costs, and accelerate deadlines.