Translation certification isn’t always required for every translation related to medical devices, but in regulated environments, there are clear cases where it’s either mandated or strongly recommended.
🧾 When Is Translation Certification Required or Expected?
✅ 1. Regulatory Submissions
- Required when submitting translated documents to regulatory bodies (e.g., EU Notified Bodies, Health Canada, ANVISA).
- Often needed for:
- Instructions for Use (IFUs)
- Labels and packaging
- Clinical Evaluation Reports (summaries)
- Post-Market Surveillance documentation
- Certifying the translation ensures regulators can trust the accuracy and fidelity of the information.
✅ 2. High-Risk Medical Devices
- These have a higher safety burden, so regulators may require or expect translation certification to mitigate risk of misuse due to language errors.
✅ 3. Legal and Safety-Related Documents
- Any content that could impact patient safety or lead to legal liability should be certified:
- Risk assessments
- Safety notices
- Recalls or corrective action reports
- Informed consent forms for clinical trials
✅ 4. Tender Submissions / International Contracts
- Some hospitals or government buyers (especially in the EU or Latin America) require certified translations to participate in tenders or procurement processes.
✅ 5. Quality System Requirements (e.g., ISO 13485)
- If your QMS references verified or validated translations, certification may be required to document translation controls.
🛑 When It’s Not Typically Required
- Internal use only documents
- Draft versions or early-stage R&D files
- Marketing materials not directly regulated (unless used for patient instructions)
🔐 What Is a Certified Translation?
A certified translation typically includes:
- A signed statement of accuracy from the translator or language service provider (LSP)
- Translator’s qualifications
- Date and a declaration that the translation is a true and accurate representation of the original
🧠 Pro Tip:
Some jurisdictions (e.g., France or Brazil) may require a sworn translator (court-authorized). Always check local laws or regulatory guidance for each target country.
If you’re preparing a submission or document set and you’re not sure if certification is needed, TDN Translation can help you check based on the document type and country. Want to go through a specific use case?
