How to Localize Labels and Instructions for Overseas Registration of POCT Products?

Key Summary

When registering POCT products overseas, the localization of labels and instructions for use (IFU) is a key compliance step that directly impacts the approval process. Manufacturers must first determine whether the target country regulates POCT products as medical devices, and then identify the registration pathway and applicant role based on the product risk class. Core references include target country regulations (e.g., EU IVDR, U.S. FDA, Southeast Asian medical device laws), product classification standards (e.g., ISO 13485, IVDD/IVDR classification rules), and existing technical documentation (e.g., NMPA registration files, CE technical files, FDA 510(k) or PMA). Localization involves language translation, unit conversion, symbol compliance with local standards (e.g., ISO 15223-1), and adaptation of intended use and target population to local epidemiological characteristics. Common risks include neglecting the local agent's or authorized representative's review responsibility for labels, overlooking post-market surveillance requirements (e.g., label changes in vigilance reports), and failing to retain change records. Manufacturers should prepare a localization strategy template in advance, prioritize reuse of core performance data, make targeted modifications only for locally required content (e.g., warnings, storage conditions, restrictions), and retain the original language version for comparison. For multi-country registrations, it is advisable to establish a unified label management system and gradually achieve regional content reuse to reduce redundant translation and correction costs.

Applicable Scenarios and Core Questions

POCT products are widely used in overseas primary care, emergency, and home settings due to their ease of use and rapid results. However, different countries have significantly divergent requirements regarding label and IFU format, content, language, and symbols. Localization is not just about language conversion but is a reflection of regulatory compliance. Manufacturers often face core questions such as: How to determine which content must be localized? Can the English or CE version of labels be used directly? What responsibility does the local agent have for the IFU? How to correct errors in the IFU after market launch? These questions need to be addressed based on the target country's medical device regulations, product classification, and registration pathway.

This guide is applicable to GHWP member states, Southeast Asia, the Middle East, Latin America, and other major overseas markets, as well as POCT manufacturers planning multi-country registrations. Manufacturers should first complete a risk class assessment in the target country and identify the registration category (e.g., A, B, C, D or I, II, III), then determine the depth of review required for labels and IFU. For example, under the EU IVDR, labels and IFU for Class A non-sterile products must self-declare compliance, while Class D products require notified body review. In the U.S., the FDA requires labels and IFU to meet 21 CFR 809.10 and device-specific requirements.

Registration Decision Logic

Step 1: Determine if the product falls under the target country's medical device regulatory scope. POCT products such as blood glucose test strips, pregnancy test strips, and rapid infectious disease tests are usually regulated as medical devices or in vitro diagnostics (IVDs). Confirm whether the country has specific regulations (e.g., ASEAN Medical Device Directive, Saudi Medical Devices Law).

Step 2: Determine the risk class based on the product's intended use and technical characteristics (e.g., whether it requires power or contains software). For example, self-test HIV reagents are classified as high risk in most countries, while professional-use urine strip analyzers may be low risk. The risk class determines the registration pathway (e.g., product registration, self-declaration, or certification).

Step 3: Assess the reusability of existing technical documentation. For POCT products with an existing NMPA registration certificate, performance verification, stability studies, and clinical evaluation (if any) can become the core of the technical file. Label designs (symbols, warnings) in CE technical files must be checked against target country requirements. IFU content from FDA 510(k) submissions can be referenced, but units, language, and local contact information must be adjusted.

Step 4: Confirm specific localization requirements, including: use of official language (e.g., Vietnamese, Arabic, Spanish); indication of the local agent or authorized representative's name and address; symbols must comply with ISO 15223-1 or local standards; intended use may need adjustment based on local epidemiology (e.g., antimalarial recommendations in Africa); storage conditions must consider tropical climates; and expiration date format (e.g., day/month/year).

Step 5: Prepare a post-market maintenance plan. Any changes to labels and IFU after registration must be reported to regulatory authorities. Establish a change control procedure to ensure that every localization update retains the original version and modification records, facilitating post-market sampling or complaint investigations.

Documentation and Evidence

For localization, the following core documents should be prepared:

• Original language labels and IFU: Provide Chinese, English, or CE text with design file numbers and version numbers.
• Localized draft: Include full translated text and a table of differences from the original version.
• Risk analysis file: Explain that localization does not affect product safety or performance, particularly for quantitative interpretation, warnings, and use restrictions.
• Symbol index: List all symbols used and cite their standard sources.
• Local agent authorization: Proof that the agent has authority to review and confirm localized content.
• Registration certificates: Certificates from the home country or reference market to support reuse of technical documentation.
• Performance verification summary: Stability data under local storage conditions (e.g., high temperature/humidity validation).
• Clinical evaluation or literature summary: Provide evidence if local population differences may affect the cut-off value.

Common Mistakes

• Directly using the English version of CE or FDA labels with only translated stickers, without considering local format requirements (e.g., font size, line spacing).
• Failing to confirm whether the local market requires a “for professional use only” or “self-test” label, leading to inconsistency with actual usage environment.
• Missing or incorrect local agent information, where the agent does not take responsibility for label content, resulting in uncontactable parties.
• Symbols not interpreted according to local standards. For example, some countries require the full wording for the “in vitro diagnostic” symbol.
• Expiry date and batch number formats differing from local practice (e.g., using MM/DD/YYYY instead of DD/MM/YYYY).
• Not retaining the original language version for comparison, making it impossible to provide evidence when regulators request clarification.
• Using the same template for multiple countries without considering warning differences (e.g., U.S. requires adverse event reporting phone number; EU requires CE mark and notified body number).
• Not notifying the local agent or regulatory authority of post-market changes, resulting in inconsistencies between label/IFU and actual product.

Manufacturer Preparation Checklist

• Have you confirmed the target country's competent authority classification and registration requirements for POCT products?
• Have you collected the target country's legal and regulatory documents on language, symbols, dimensions, and content of labels and IFU?
• Have you appointed a qualified local agent or authorized representative and signed a contract clarifying their responsibility for label review?
• Have you established an original language template and flagged variable parts (e.g., temperature range, agent information)?
• Have you completed the localization draft and had it reviewed by the local agent or a professional translation agency?
• Have you saved the risk analysis document explaining that localization changes do not affect product safety or effectiveness?
• Have you prepared performance verification data to demonstrate product stability under local storage and use conditions?
• Have you established a post-market IFU change control procedure that includes version management, change records, and notification to regulatory authorities?
• For simultaneous multi-country submissions, have you used a matrix table to compare requirements across countries to avoid duplication?
• Have you allocated sufficient time (typically 2–4 months) for translation, review, and registration submission?

AIMEILI Insights

The most common misjudgment in POCT overseas registration is assuming that simple translation of labels and IFU is sufficient for submission. In reality, localization must comply with substantive local regulatory requirements. For example, the wording of warnings may need to be adjusted according to local pharmacopoeia or clinical guidelines. At the project outset, manufacturers should complete a regulatory survey of the target country and clearly identify which content cannot be modified (e.g., intended use, performance claims) and which can be localized (e.g., storage conditions, agent information). Core performance data and clinical evaluation materials are usually reusable, but the physical design of labels (e.g., QR codes, symbols) must be produced according to local standards.

The role of the local agent is critical. They not only submit documents on behalf of the manufacturer but also take responsibility for the accuracy of labels. Therefore, choose a company with experience in medical device registration and require their participation in the review. Regarding control of certificates, manufacturers must ensure that the local agent does not unilaterally modify label content attached to the registration certificate. Any change requires mutual agreement and retention of original documents. For multi-country registrations, we recommend using a unified core template with adjustments only for language and country-specific content, supported by a version management system. This approach significantly reduces errors and correction costs caused by redundant rework.

Common Follow-up Questions

Q: If a product already has a CE label, can it be used directly in other countries?

No. a CE label is based on EU regulations, and its warnings (e.g., in German, French, Italian), symbols, and contact information may not meet the regulations of other countries. For example, Saudi Arabia requires the importer's information on the label, and Brazil requires Portuguese IFU approved by ANVISA. Even if the content appears similar, the label must be redesigned according to local requirements and accompanied by a statement of differences.

Q: Does localized label and IFU require re-validation of performance?

If the changes are limited to language, format, contact information, or other non-technical elements, re-validation of performance is usually not required. However, if localization adjusts the intended use (e.g., from professional use to self-testing), storage temperature range, or expiry date, additional stability or clinical data may be necessary. It is recommended to clearly document the decision in the risk analysis and, when in doubt, consult the local agent or regulatory authority.

Q: For multi-country registration, can a single English label be used with additional local language inserts?

Some regions accept this practice (e.g., parts of the Middle East), but many markets require all information to be on the same label or IFU in the official local language. For example, Vietnam requires Vietnamese as the primary language, with English as a subtitle; Indonesia requires Indonesian as the primary language. A unified English insert may lead to label confusion and increase the risk of missing warnings. We recommend separately designing materials for each language while reusing core data.

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Recommended readings

• How to select a local agent for overseas registration of IVD products?
• How to divide responsibilities of the authorized representative for overseas registration of IVD products?
• Why is the registration timeline for IVD products extended?
• What are common reasons for supplementary information requests during IVD product registration?
• How to conduct post-market surveillance for overseas-registered IVD products?
• When is a registration change application required for IVD products?

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Content Review and Applicability

Author: AIMEILI Regulatory Editorial Team
Professional Review: AIMEILI Medical Device International Registration Project Team
Source Principle: Priority is given to official regulatory authorities, international organizations, standard organizations, and publicly available regulatory information; industry media and project experience are used only as supplementary references.
Applicability: This article is intended for preliminary understanding, documentation preparation, and project planning. It does not replace official requirements, testing conclusions, or legal advice from target country regulatory authorities.