How to Group Multiple Models for POCT Overseas Registration

Key Summary

Grouping multiple models in a single application is a critical strategy to reduce registration costs and shorten approval timelines for POCT products overseas. Companies must first determine whether the product falls under the target country's medical device regulations and its risk classification. For GHWP member states, Southeast Asia, the Middle East, and Latin America, grouping is typically based on core elements such as technical principle, intended use, and key performance indicators. Common grouping principles include: same technology platform (e.g., immunochromatography, electrochemical, photochemical), same detection principle, similar clinical performance, shared key components (e.g., sensors, reagent formulations), and identical quality management system. A master technical file (STED) covering all models' common features should be prepared, supplemented by documents addressing differences such as performance validation data, risk assessment, and labeling variation analysis. Common risks include forcibly grouping models with significant clinical performance differences, leading to overall approval difficulties; neglecting local agent requirements for grouping compliance; and failing to consider post-market changes affecting the grouping. It is recommended to reference existing NMPA, CE, FDA, ISO 13485, or MDSAP certifications for localization. For multi-country registration, core technical files are reusable but must be translated and adapted to meet specific national requirements (e.g., Brazil ANVISA RDC, Thailand TFDA notification). The grouping strategy should be determined at the project initiation stage, with full communication with local agents and authorized representatives to ensure certificates cover all models and change/renewal remains manageable. Compiled from AIMEILI's registration practice database, medical device international registration knowledge base, and public regulatory information; specific projects should be based on the latest requirements of the target country's regulatory authority and product documentation.

Applicable Scenarios and Core Issues

When registering POCT products overseas, companies often face the challenge of applying for multiple models. For example, a product line of glucose meters, immunochromatographic test strips, or electrochemical analyzers may include various models with different test items, ranges, or packaging sizes. Submitting separate applications for each model would multiply registration costs and timelines. Thus, grouping becomes a core strategy. However, regulatory authorities impose strict limitations: US FDA typically requires each model to submit an individual 510(k) unless substantial equivalence within the same family is proven; under EU IVDR, the same device family can share technical files, but performance evaluation must cover all models; GHWP member states such as Saudi Arabia, Indonesia, and Thailand allow grouping based on technical similarity but require sufficient evidence. Companies must first determine whether the product falls under the target country's medical device regulations—for instance, some home-use POCT products in certain Southeast Asian countries may be classified as health products rather than medical devices, exempting them from registration. Next, risk classification must be determined: higher classification increases grouping difficulty; for example, IVD products for diagnosing infectious diseases are typically Class C or D, requiring extra attention to clinical performance differences. Finally, assess whether existing certifications (NMPA, CE, FDA) can be reused. If CE-IVDR certification has been obtained through an EU notified body, technical files can be largely reused but must be localized for target country regulations, e.g., Brazil requires Portuguese labeling, Mexico requires a COFEPRIS-approved risk analysis report.

Registration Decision Logic

The first step in grouping is determining whether the products belong to the same device family or generic specification. The following logic applies:

• Consistent technical principle? For example, all models based on the same immunochromatographic method using identical antibodies, substrates, and reading devices may be considered similar.
• Same intended use? If some models detect different disease markers (e.g., troponin vs. D-dimer), intended uses differ and grouping is typically not allowed.
• Acceptable key performance parameters? Differences in sensitivity, specificity, linear range, etc., should not exceed predefined thresholds; otherwise, separate data is required.
• Shared quality management system? All models should be manufactured under the same QMS (ISO 13485 or MDSAP) with consistent change management.

If these conditions are met, a master-variant model approach can be used: one representative model serves as the master with a full technical file, while other models provide only a difference analysis. For example, a master model with full-range glucose meter, and other models as low-range or high-range versions with differences only in software algorithms and calibration curves—submit separate validation data. If the target country allows family registration, all models share one application, but the certificate will list each model's specifications. For instance, the Indonesian Ministry of Health requires listing all model catalog numbers and names; otherwise, unregistered.

Materials and Evidence

For grouped applications, prepare the following core materials:

• Master Technical File (STED): product description, design principles, material list, manufacturing process, quality control indicators. Clearly state grouping rationale and provide a comparison table of model differences.
• Performance Validation Reports: Master model requires full analytical performance evaluation (precision, linearity, interference, stability). Variant models may only require bridging tests (e.g., comparison with master showing equivalence).
• Clinical Evaluation or Evidence: For high-risk products, clinical trials or literature data may be needed. If models have significantly different clinical performance, submit separate clinical evidence.
• Risk Management File: Per ISO 14971, covering intended uses, known hazards, and risk control measures for all models. Explain that risks are acceptable for each model.
• Labeling and IFU Difference Analysis: Address parameter differences that might affect safety, e.g., different reference ranges for test strips.
• Localized Documents: Local language labels, IFUs, agent authorization, free sale certificate (if required).

Additionally, provide evidence supporting grouping rationality, such as: shared key technology platform (e.g., same sensor, optical system, algorithm); batch production records showing component commonality >80%; internal verification reports showing performance deviation within acceptable limits (e.g., CV <5%); third-party testing reports (e.g., BOM comparison, software version consistency).

Common Mistakes

• Blindly pursuing number of groups: forcibly merging models with obvious clinical performance differences leads to reviewer questions or requests for extensive additional data, prolonging registration.
• Ignoring local regulatory uniqueness: e.g., Philippines requires separate review fees per model; India demands independent clinical data for each model.
• Neglecting post-market change impact: a change in one model may require reassessment of the entire group, affecting all certificates.
• Improper local agent selection: some agents fail to verify grouping compliance, resulting in rejection.
• Technical files lacking difference analysis: merely stating models are similar without providing any comparative data or threshold definitions.

Company Preparation Checklist

• Project Initiation Assessment: Confirm grouping feasibility in target countries (review local grouping guidelines or consult agents). Select master model (usually best-performing or highest-selling).
• Technical Preparation: Create grouping comparison table (attributes, parameters, differences). Prepare full master technical file and bridging test protocols for variants. Complete risk management reports for all models (integrated but highlighting different risk points).
• Quality System: Ensure all models under same QMS with consistent change management. Prepare MDSAP certificate if available (cover all models).
• Localization: Translate and produce labels and IFUs for each model (note parameter differences). Sign authorization agreement with local agent specifying grouping requirements.
• Post-Submission: Track review comments; provide supplementary evidence if grouping is challenged. After approval, ensure certificate lists all models and manage updates.

AIMEILI Expert Opinion

From our experience serving many POCT companies in overseas registration, the biggest mistake in grouping is grouping for the sake of grouping. Many companies blindly follow peers without considering substantive differences among their own models. Our core advice is to first conduct a grouping feasibility pre-assessment, investing a small effort to study target country regulations and review cases—far more efficient than later submitting massive supplementary data. Early in the project, we strongly recommend compiling all model technical parameters, identifying 1-2 master models, and designing bridging tests for differences. For example, a company with 12 glucose test strip models grouped merely by packaging size was required to provide stability data for each package, increasing costs. If packaging does not affect performance, they could be grouped with stability studies (at least three batches) proving consistency. For document reuse, 95% of core technical files can be shared, but clinical evaluation, performance localization, and label translation must be localized. Pay special attention to Brazil and Mexico, which have independent clinical data requirements and cannot directly cite CE parameters. Regarding local agents and certificate control, in multi-country registration, choose experienced agents who can proactively assess grouping feasibility and manage changes and renewals across multiple certificates. Finally, adopt a master file + country appendix approach: one master file covering all models, each country adding local requirements—this significantly reduces rework and correction risks. Remember, grouping is not the goal; efficient and compliant certificate acquisition is.

Frequently Asked Questions

How can I determine grouping feasibility if the target country has no explicit guidelines?

Check whether the country recognizes the device family concept, or refer to IMDRF guidelines such as 'Principles of Medical Device Classification' and 'Same Device Family' documents. If no clear rules, consult local experienced agents or submit a pre-submission inquiry to the regulatory authority (e.g., Brazil ANVISA's consultation process). Generally, lenient countries (e.g., some Southeast Asian) accept grouping based on equivalence, while strict countries (e.g., Japan) require individual registration for each model. For example, Thailand TFDA allows 'list of variants' approach for IVD series if a consistency declaration is provided.

If one model in a grouped registration undergoes a change (e.g., reagent formulation adjustment), does the entire group need re-registration?

It depends on the nature of the change. If the change does not affect safety and effectiveness of all models and the changed model is already certified, usually only a change registration is needed, specifying the scope. However, if the change involves core technical principles, it may impact the entire group and require reassessment and re-testing. It is recommended to establish a change management plan during registration, defining minor changes (e.g., labeling modifications not affecting performance) and major changes (e.g., reagent component changes). Under EU IVDR, major changes require supplementary technical file submission and notified body review, but other models in the group remain valid.

How do I unify grouping strategies across different target countries with varying requirements?

Adopt a global master folder strategy: compile all model technical differences into a globally applicable matrix table, then tailor for each country's requirements. For example, a POCT immunoassay analyzer may be grouped under EU IVDR by considering all reagent kit models as the same device family, while China NMPA requires individual kit registration. In such cases, create a globally applicable master technical file, but provide separate sub-files for each country explaining grouping logic and attaching difference evidence. This avoids duplication, but note that clinical data requirements may differ; do not force unification. If a country requires independent clinical reports per model, grouping is not possible and separate submissions are needed.

Execution Recommendations

In practice, break the issue into five tasks: regulatory assessment, document preparation, evidence reuse, localization, and post-market maintenance—rather than having one department compile files ad hoc. This helps identify gaps earlier and ensures sales, R&D, quality, and regulatory teams align on target country requirements. For multi-market entry, first create a unified core technical file, then supplement each country with authorization, labels, language, forms, and local agent documents. The efficiency of multi-country registration often depends on whether the initial document framework is unified, not on individual country submission speed. First, confirm whether the product falls under the target country's medical device regulations. Then, determine risk classification, registration pathway, and applicant. Cross-check technical files, quality system, and clinical evidence for mutual support. Clarify local agent, authorized representative, and certificate control. Establish post-market change, renewal, and vigilance maintenance mechanisms.