Medical device localization involves more than translation – it’s the process of adapting a device and its supporting materials to a target market’s language, cultural expectations, clinical workflows, and regulatory requirements. Accurate localization ensures the device is understood, accepted, and used safely by healthcare professionals and patients in that market.
This article explains why localization matters, highlights the key linguistic, cultural, and regulatory steps you must take, and outlines practical strategies to bring medical devices into new markets while minimizing safety and regulatory issues.
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Contents
- What is Medical Device Localization & Why Do You Need It?
- How Are Medical Devices Localized?
- What Regulatory Authorities Govern Medical Device Localization?
- What Are the Different Medical Device Localization Certifications?
- What Are the Challenges of Medical Device Localization?
- What Is the Role of Specialist Translators in Medical Device Localization?
What is Medical Device Localization & Why Do You Need It?
Medical device localization is the process of adapting a device and all its supporting content so that it is linguistically correct, culturally nuanced, clinically accurate, and legally compliant in a specific market.
For example, a glucose meter that displays readings in the wrong units or uses instructions that aren’t culturally clear can cause dosing errors or misuse. This small oversight in localization can therefore become a significant risk to patient safety and compliance. This is just one example of the cultural nuances that make accurate localization essential.
Here are the most important reasons why you must consider medical device localization:
Reduces Interpretation Risks
Clear, native-language instructions, properly-localized units, date/time formats, and numeric styles reduce misinterpretation that can lead to clinical errors or improper use. Using specialist medical language expertise and QA workflows cuts translation errors and preserves clinical intent.
Ensures Cultural Appropriateness
Localization goes beyond words: iconography, colour choices, consent wording, and clinical examples must match local cultural norms and clinical workflows so materials are accepted and trusted by clinicians and patients in the target market. Poor cultural fit harms adoption and can create safety misunderstandings.
Improves Clarity for Patients & Professionals
Patients and healthcare professionals make better decisions when labels, IFUs, and software flows are clear, concise, and written for their reading level and clinical context. For Software as a Medical Device (SaMD), consistent UI language and properly-localized prompts reduce user errors and improve clinical outcomes.
Meets Local Regulations & Standards
Many countries require device information and documentation in specific languages to support safe use; the EU MDR, for example, sets out language requirements that manufacturers must follow. Failing to meet those rules can block market access or trigger corrective actions, hindering the progress of your device’s global reach.
Expands Market Reach
Accurate, compliant localization removes legal and usability barriers, enabling you to launch in more countries with confidence – shortening time-to-market and increasing adoption among clinicians and patients. Working with experienced localization partners helps scale translations while maintaining ISO/quality practices.
How Are Medical Devices Localized?
Here are the practical tasks and checks performed for each aspect of medical device localization:
Linguistic Adaptation
- Translate clinical text, instructions for use (IFUs), warnings, and marketing copy using medically-qualified translators.
- Create glossaries, terminology databases, and translation memories (TMs).
- Perform linguistic QA and in-country review to preserve clinical intent and tone.
Cultural Adaptation
- Check icons, imagery, color use, examples, and consent wording for cultural meaning and acceptability.
- Adapt imagery and patient scenarios to local clinical practices and health-seeking behavior so materials feel familiar and minimize misunderstanding.
- Qualified local clinical reviewers or a localization partner usually validate these changes.
Regulatory Compliance
- Identify language and documentation obligations for the target nation (e.g., EU MDR language tables, FDA labeling rules).
- Translate any documents required for submission (IFUs, labels, technical files, clinical summaries).
- Keep translations under your Quality Management Systems (QMS) with change control and traceability.
Technical & Unit Adjustment
- Convert units of measure, numeric and date/time formats, decimal separators, and localize units used in dosing, calibration, and results display.
- Verify measurement conventions (e.g., mmHg vs kPa, mg/dL vs mmol/L).
- Ensure device firmware/algorithms use the correct units for the target market.
Software & User Interface (UI) Localization
- Extract strings into resource files, support Unicode and bidirectional text where needed, design for text expansion/contraction, localize error messages and help content, and retest the UI in the target language with real users (usability testing).
- For SaMD, also review language in clinical decision prompts, data displays, and patient-facing messages as part of verification and validation.
Labeling Localization
- Update on-device labels, packaging, and barcode/UDI text to the required language(s).
- Ensure translated symbols, storage/sterilization instructions, and safety warnings appear correctly on the physical label and in packaging inserts.
- Maintain final artwork versions and evidence of linguistic verification for regulators.
What Regulatory Authorities Govern Medical Device Localization?
When planning to market your medical device internationally, it’s crucial to understand the regulatory authorities that govern each country where the device will be distributed. These include:
- Localization in European Countries: The EU’s MDR/IVDR set the overarching translation requirements, but language rules are implemented by each EU Member State. Manufacturers must follow the national language requirements where the device will be marketed.
- Localization in the USA: The US Food & Drug Administration (FDA) regulates device labeling and requires that, for products distributed in the United States, labels must be in English.
- Localization in Canada: Health Canada enforces the Medical Devices Regulations; devices sold to the general public must include both English and French directions for use, while other devices must be labeled in at least one official language.
- Localization in China: The National Medical Products Administration (NMPA) requires submission documents, labels, and IFUs to be in Chinese; approvals often reference the exact Chinese IFU and label text submitted during submission.
- Localization in Australia: The Therapeutic Goods Administration (TGA) requires that labeling and information supplied with devices enable safe use in Australia – English is the primary language of regulatory expectation.
What Are the Different Medical Device Localization Certifications?
Several important certifications and standards play a crucial role in medical device localization; each one demonstrates quality, expertise, and compliance in this highly-regulated field. At Conversis, we’re proud to hold accreditation in the most recognized and relevant standards, such as:
ISO 17100
Awarded by the International Organization for Standardization (ISO), ISO 17100:2015 sets out the processes, resources, and requirements needed to deliver high-quality translation services that meet specified standards.
When a specialist translation partner implements ISO 17100, it shows – through documented processes and qualified resources – that it can reliably produce translations that meet the client’s requirements and any other applicable specifications.
ISO 9001
ISO 9001:2015 is the international standard for Quality Management Systems, designed to help organizations consistently meet customer and regulatory requirements. It provides a structured framework for managing processes, promoting continuous improvement, and maintaining customer satisfaction through principles such as a strong customer focus and a process-driven approach.
While ISO 9001 doesn’t directly guarantee product quality, it ensures that the processes behind products and services are well-controlled, consistent, and continuously improved.
What Are the Challenges of Medical Device Localization?
Localizing medical devices raises recurring “pain points” for healthcare organizations. Below are the typical problems our clients face, and how you can avoid them:
Terminology & Consistency
Medical text uses exact, safety-critical terms. Inconsistent terminology across IFUs, labels, UI, and clinical documents causes confusion and clinical risk.
To overcome this, create and enforce a central glossary and terminology database which are version-controlled. You should also consult professional clinical reviewers to approve key terms and include their sign-off in the record.
Regulatory Traceability
Regulators expect demonstrable traceability for every translated element (who approved it, when, and against which source). Poor traceability can lead to delayed approvals.
To overcome this, treat translations as controlled documents within your QMS (change control, document numbering, retention). Keep linguistic verification records, certificates from your specialist translation partner, and evidence of in-country review in the technical file.
Usability & Human Factors
Literal translations can break usability. Wording, UI layout, icons, and workflows must match local clinical practice; otherwise, human factors testing will reveal use errors.
To overcome this, build linguistic usability testing into your human factors plan (test the localized IFU, UI, and labeling with representative users). You should also involve clinicians from the target market in scenario-based testing and capture measured task performance and comprehension.
Turnaround & Scale
Your product may need translations into dozens of target languages, and those translations must be updated quickly whenever the product changes. Scaling rapidly while keeping quality is challenging, especially for smaller pharma and biotech companies.
To overcome this, establish scalable workflows involving translation memories, terminology management, automation for file extraction, and parallel review tracks. Publish release windows and SLAs in your change-control process so localization work is planned, not ad hoc.
Validation & Acceptance
Regulators and customers expect formal validation and acceptance for localized outputs (IFUs, labels, SaMD UI). Informal checks simply are not enough.
To overcome this, define acceptance criteria up front (linguistic QA pass/fail metrics, reviewer sign-off, usability thresholds). Include localization in your verification & validation plan for SaMD – test the localized UI and clinical logic under the same protocols used for the base product.
What Is the Role of Specialist Translators in Medical Device Localization?
Specialist translation partners like Conversis turn localization from a time-consuming checklist into a fast, auditable, repeatable process. Our team of native medical translators ensures accurate and regulatory-compliant translations from experts, ensuring your medical device reaches markets faster, with fewer review cycles and stronger evidence for regulators.
To accelerate compliant market entry and reduce regulatory risk, our subject matter experts offer:
- Project & regulatory mapping for each target market.
- Native, medically-qualified translators and in-country clinical reviewers.
- Centralized glossaries and translation memories for consistency and reuse.
- Linguistic usability testing to catch human-factors issues early.
- Secure, scalable workflows that run tasks in parallel to cut calendar time.
Speak to Our Life Sciences Localization Team Today
With over 20 years focused exclusively on life sciences, Conversis delivers specialist, regulatory-ready medical-device translation and end-to-end support – from preclinical research and submissions to post-market surveillance.
To streamline your device localization and reach your target market faster, get in touch with us today.
