and labeled products are shipped in accordance with regulatory standards.

4) Procedure

4.1 Understanding Multi-Language Labeling Requirements
4.1.1 Regulatory Requirements for Multi-Language Labeling
– Ensure that medical device labels and inserts are printed in the languages required by each regulatory authority. Common requirements include:
– EU Regulations (EU MDR 2017/745): Requires product labels and IFUs to be provided in the official languages of the EU member states where the product will be marketed.
– FDA Requirements (21 CFR Part 801): Requires that labeling be in English for devices sold in the U.S. but allows for foreign language translations on a case-by-case basis.
– Other International Markets: Each country or region may have specific language requirements, such as Canada (English and French), Switzerland (German, French, and Italian), and the Middle East (Arabic).

4.1.2 Key Elements to Translate
– Ensure that all critical information on the label and IFU is translated, including:
– Product Name and Description
– Instructions for Use (IFU)
– Warnings and Cautions
– Regulatory Symbols and Statements
– Storage Conditions
– Expiration Date (if applicable)
– Manufacturer Information
– Lot Number and Serial Number Information

4.2 Translation Process
4.2.1 Selecting Translation Service Providers
– Choose professional and certified translation service providers who have expertise in medical device labeling and who are familiar with the regulatory requirements of the target markets.
– Certification: Ensure the translation service provider is ISO-certified or complies with relevant standards, such as ISO 17100 for translation services.
– Qualifications: Verify that translators are qualified, particularly for technical and medical terminology.

4.2.2 Translation Process Steps
– Original Text Review: Review the original content for consistency and clarity to ensure it is easy to translate.
– Translation: The translation service provider will translate the text from the source language(s) to the target language(s), ensuring that technical terms are accurate and that regulatory requirements are met.
– Proofreading and Verification: After translation, the content should be reviewed and proofread by experts to ensure accuracy and clarity in the target language.
– Back-Translation: For highly sensitive or critical content, use back-translation (translating the target language back into the original language) to verify accuracy.

4.2.3 Approval Process
– Once the translations are completed, follow the approval process to ensure the final labels and IFUs are correct:
– Internal Review: Regulatory Affairs, QA, and the Packaging Team review the translated text for accuracy and compliance with regulatory requirements.
– Regulatory Compliance Check: Ensure that all required languages are included and that the content complies with the local regulations.
– Final Approval: Once the translations are verified and approved, sign off on the final version for production and labeling.

4.3 Label and Packaging Design for Multi-Language Content
4.3.1 Designing the Label for Multi-Language Use
– Ensure that the design of labels and packaging can accommodate multi-language content, considering factors such as:
– Text Length Variations: Different languages may have varying text lengths, so design labels and inserts with enough space to handle longer or shorter translations.
– Font and Readability: Choose fonts that support all required characters and alphabets for the target languages.
– Legibility: Ensure that font sizes are legible in all languages, including any regulatory or cautionary statements.

4.3.2 Layout Considerations
– Layout the packaging and label design in a way that allows for multi-language text to be presented clearly:
– Separate Language Sections: Group translations into clear sections on the packaging and insert, each with a corresponding language.
– Regulatory Symbols: Include internationally recognized symbols to convey important safety and usage information across different languages.
– Printing Quality: Use high-quality printing techniques to ensure that all languages are legible and do not blur, particularly for small font sizes.

4.4 Verification and Validation of Translated Labels
4.4.1 Verification of Translated Text
– Ensure that the translated text matches the original content in meaning and intent, especially for critical information:
– Accuracy Check: Verify that all translations are technically accurate and culturally appropriate.
– Consistency Check: Ensure that common terms are consistently translated across all labels and packaging.
– Regulatory Compliance Check: Confirm that the translated text meets the regulatory requirements of each target market.

4.4.2 Validation of Translated Labels
– Conduct validation of translated labels and inserts in actual packaging scenarios:
– Sample Testing: Print a sample of the label or insert in each language and check for proper printing, text clarity, and readability.
– User Testing: If applicable, conduct user testing to confirm that the translated instructions are easily understood and that no critical information is lost in translation.

4.4.3 Final Approval of Translated Labels
– Once all translations have been verified and validated, ensure final approval from QA and Regulatory Affairs before printing and applying labels to products.

4.5 Record Keeping and Documentation
4.5.1 Documentation of Translations
– Maintain comprehensive records of all translation and review activities:
– Translation Files: Keep a record of the original text, translated text, and translation certificates.
– Approval Documentation: Retain records of internal reviews and final approvals of translations and packaging design.
– Regulatory Compliance: Ensure that all translations are documented to demonstrate compliance with relevant regulatory bodies.

4.5.2 Record Retention
– Retain translation records and approval documents for a minimum of five years, or as required by regulatory authorities.

4.6 Compliance and Regulatory Requirements
4.6.1 Compliance with UDI and Labeling Regulations
– Ensure that multi-language labels comply with the UDI system and relevant medical device regulations, including:
– FDA 21 CFR Part 801: Requirements for medical device labeling in the U.S.
– EU MDR (Regulation (EU) 2017/745): Requirements for medical device labeling in the EU, including language requirements.
– ISO 13485: Quality management systems for medical devices, which include requirements for labeling.
– ISO 17100: Translation services standards, ensuring that translations are accurate and reliable.

4.6.2 Regulatory Audits and Inspections
– Provide records of translation and labeling activities during regulatory inspections or audits, including:
– Translated labeling and IFUs.
– Documentation of regulatory compliance for multi-language requirements.
– Records of any corrective actions taken for labeling discrepancies.

5) Abbreviations

– UDI: Unique Device Identification
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– FDA: Food and Drug Administration
– ISO: International Organization for Standardization

6) Documents

– Translation Certificates
– Label Approval Records
– Proofreading and Verification Logs
– Regulatory Compliance Records

7) Reference

– FDA CFR Title 21, Part 801: Quality System Regulation
– ISO 13485: Medical Devices – Quality Management Systems
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements
– ISO 17100: Translation Services – Requirements for Translation

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Translation Approval Record Template

Date	Language	Device Name	Translated By	Approval Status
DD/MM/YYYY	French	Device ABC	Translator XYZ	Approved

Annexure 2: Multi-Language Label Design Template

Language	Text Description	Approval Status
Spanish	Instrucciones para el uso	Approved