How Should Multiple Models Be Grouped for Overseas Registration of Imaging Devices?

To group multiple models for overseas registration of imaging devices, manufacturers must first confirm the product classification and regulatory pathway in each target country, then demonstrate that the models share the same basic structure, critical components, and intended use. Grouping can reduce duplicate testing and documentation, but requires a robust evidence chain including model difference tables, representative model full testing reports, and coverage declarations.

Published: 2026-08-13 19:58 | Updated: 2026-08-13 19:58

Executive Summary

In overseas registration of imaging devices, multiple models are often submitted as a series or family. However, grouping rules, technical documentation requirements, and fee structures vary significantly by country. Companies cannot simply apply domestic registration unit divisions or directly copy CE or FDA series declarations. Before deciding on grouping, you should first confirm whether the product falls under the medical device regulatory scope in the target country, then determine its risk class, registration pathway, and applicant entity. Most GHWP member states allow models with the same basic structure, critical components, and intended use to be grouped as one registration unit, but they require a model difference table, a full testing report for a representative model, and a coverage declaration.

The core value of grouped submissions is reducing duplicate testing and documentation, but only if the evidence chain is sufficient. Common risks include forcing models with significant functional differences into one group, leading to requests for amendment, or overlooking local agent and authorized representative requirements, resulting in rejected applications. Companies should first review their global registration strategy, assess the reusability of existing NMPA, CE, FDA, or ISO 13485 documentation, and then perform localized adaptation for local language, labeling, instructions for use, clinical evaluation, and post-market surveillance requirements.

Source: Compiled based on AIMEILI registration practice question bank, 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 authorities and the product dossier.

Applicable Scenarios and Core Questions

Imaging device companies often face the practical question of multiple models in the same product line, such as different detector sizes, different power levels, different software versions, or different monitor configurations. Submitting each model individually is expensive, time-consuming, and may prompt regulators to question the substantial equivalence of the product family.

Grouped submission is not supported by all countries, nor can all models be placed in the same registration unit. Companies must first clarify what "grouped submission" means in each jurisdiction. In GHWP member states, most regulators accept model combinations based on the same basic structure, critical components, and intended use, but require specific difference analysis and coverage declarations. In the EU, "same family" under MDR has strict requirements; in the US, similar effects are typically achieved through the same device product series under 510(k) or PMA supplements.

The core question is not "whether grouping is possible" but "how to prove these models belong to the same technical family." Regulators will examine product structure, working principle, key performance indicators, applicable safety standards, and the common basis of clinical evidence. If models differ only in appearance or non-critical configurations, the risk of grouped submission is low; if changes involve core components, algorithms, or clinical indications, separate submissions may be required.

For example, a digital radiography system may include multiple models with different flat panel detector sizes, typically considered the same registration unit. But if one model uses a different X-ray source assembly or a different number of channels, it may affect core radiation safety indicators, and regulators may require separate evaluation.

Registration Decision Logic

Companies should use a tiered decision logic to determine whether and how to group submissions.

Step 1: Determine whether the product falls within the target country's medical device regulatory scope. Some imaging devices, such as medical displays and ultrasound diagnostic systems, are regulated as medical devices in some countries and as ordinary electronic devices under IEC standards in others, not subject to medical device registration.

Step 2: Determine risk class and registration pathway. Imaging devices are usually Class II or III, but may also be Class I or exempt; each target country's classification rules must be reviewed.

Step 3: Assess whether existing documentation can be reused. If the company already holds an NMPA registration certificate, CE certificate, or FDA marketing authorization, technical files, test reports, and quality management system certificates can serve as a basis. ISO 13485 and MDSAP certificates are highly versatile in multi-country submissions and can significantly reduce system audit costs.

Step 4: Confirm requirements for technical documentation, performance verification, risk management, clinical evaluation or clinical evidence, labeling and instructions, and local agents or authorized representatives. These requirements vary greatly among countries; for example, some Southeast Asian countries accept CE reports but require local language labeling and a designated local agent.

When finalizing the grouping strategy, consideration must be given to the fee structure of the target country. Some countries charge per registration unit, others charge per model. If charging per model, grouping only reduces documentation burden, not official fees. Most registration application forms require model names, model specifications, and registration unit names. Avoid mixing models with different intended uses in the same form, as this may lead to disputes when supplementing clinical data.

Materials and Evidence

For grouped submissions, the key to documentation is establishing an evidence chain of "core model plus covered models."

The following materials are needed:

• Product family description and naming rules.
• Model difference table listing hardware, software, function, and intended use differences for each model.
• Full testing report for a representative model, usually the one with the most comprehensive performance and highest risk.
• Safety and performance verification reports for differential models, proving that differences do not affect key indicators.
• Risk management documentation covering the same risk assessment and residual risk analysis for all models.

Software-based imaging devices also need software description documents, including software version naming rules, cybersecurity statements, and software change records. When multiple models share the same software platform but have different configurations, the equivalence of software versions should be described.

For clinical evidence, if the representative model has already undergone clinical evaluation, covered models can reference it through equivalence argumentation rather than new testing. Substantial equivalence should be based on three dimensions: intended use, technological characteristics, and biological characteristics.

Labels and instructions must cover all models and comply with target country language requirements. High-risk imaging devices such as CT and MRI require additional evidence related to use environment, radiation safety, and electromagnetic compatibility. If the company holds a CE certificate and the target country recognizes CE technical files, CE summaries and test reports can be used as a basis. But note that the CE concept of a "single medical device" is not exactly the same as another country's registration unit and must be reorganized.

Common Mistakes

Common mistakes include grouping too loosely, insufficient evidence, and relying on a single country's experience.

• Forcing models with significantly different functions into one registration unit, e.g., placing products with different imaging principles together, leading to requests for amendment.
• Submitting only the representative model's test report without difference analysis and supplemental testing for all covered models, leaving coverage inadequate.
• Ignoring legal responsibility of local agents and authorized representatives, causing rejection or post-market liability.
• Applying CE or FDA grouping logic without redefining the registration unit according to target country requirements.
• Failing to confirm label and instruction language and regulatory requirements in advance, leading to non-compliance at market launch.
• Lacking a post-market surveillance plan and inadequate change control for covered models, freezing registration certificates.

Additionally, some companies fail to manage changes to covered models after obtaining a registration certificate, such as adding new configurations or changing software algorithms, without filing a change application, resulting in discrepancy between the certificate and actual product status.

Company Preparation Checklist

Before starting a grouped submission, companies should check the following items.

• Completed product classification and registration pathway research for target countries.
• Confirmed applicant entity and whether a local agent or authorized representative is required.
• Arranged a model list and identified hardware, software, and intended use differences among models.
• Confirmed reusable test reports, quality system certificates, and clinical evidence.
• Established the selection principle for representative models and completed difference coverage argumentation.
• Prepared localized labels, instructions, and compliance documents.
• Planned post-market surveillance and change control processes.
• Evaluated the timeline and budget for multi-country registration to avoid local delays impacting the overall plan.

This checklist should be reviewed at various stages: project initiation, documentation preparation, submission, and review. Since format and language requirements vary significantly by country, a local regulatory consultant should perform a conformity check before submission.

AIMEILI Regulatory Interpretation and Business Impact

The most common misjudgment is equating "shared technical documentation" with "automatically permitted grouping." In fact, different regulators have different logic for dividing registration units, and even within the same GHWP member state, different reviewers may reach different conclusions. AIMEILI recommends completing a regulatory framework assessment early in the project and creating a product family vs. registration unit mapping table.

For most imaging device companies, the greatest efficiency gain comes from modularizing the technical file system. Treat risk management, electrical safety, EMC, software verification, and performance testing as independent modules, then combine them according to each country's specific requirements. This significantly reduces rework and amendment risk.

The responsibility of local agents is often underestimated. In many countries, the registration certificate holder is a local agent or legal entity, not the overseas manufacturer. This means control of the certificate, change applications, and post-market affairs must be executed through the agent. Companies should clarify the agent's service scope, response time, certificate ownership, and exit mechanism at the start of cooperation.

For multi-country registration, it is recommended to manage versions through a unified product technical master file plus minimal country-specific difference modules. Any design change must be assessed for its impact on registered models, and each country must be tracked for whether a change application or re-registration is required. Embedding compliance requirements into the R&D phase is the only way to truly reduce the long-term cost of grouped submissions.

Common Follow-up Questions

Does grouped submission mean all models can use one test report?

No. Even with grouped submission, each model must still meet applicable product standards. Testing bodies usually issue a full report for the representative model only, but covered models must confirm through difference assessment that their safety and performance are not inferior to the representative model. If a model uses core components from a different supplier, supplemental test data may be required; simple coverage is not acceptable.

Can grouping rules be unified across countries?

No. GHWP member states reference international standards but implementation differs. For example, some Southeast Asian countries allow series products to be registered under one certificate, while others require each model to be applied separately. We recommend developing a submission strategy per country and using the strictest submission requirements as the baseline to ensure documentation meets the most effective standards.

Should companies consider overseas grouped submission in the R&D phase?

Yes. Early consideration allows product design to retain more common components, reducing extra testing and documentation caused by later differences. Change control in R&D directly affects the validity of registration evidence. Waiting until pre-registration to organize model differences often results in a reactive, higher-cost approach.

Does grouped submission affect post-market change management?

Yes. Under grouped submission, changes to the registration certificate are usually related to the core model and covered models. If the core model undergoes substantive changes, the registration status of all covered models may be affected. Companies need a change impact assessment process and must keep the agent informed.

Continued Reading

• Previous: When should a change application be submitted for overseas registration of imaging devices?
• Next: How should performance verification data be prepared for overseas registration of imaging devices?
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Content Review and Applicability

Author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team.

Source principles: Priority is given to official regulators, international organizations, standards bodies, and public regulatory information; industry media and project experience are used only as supplementary judgment.

Applicability: This article is for early understanding, documentation preparation, and project planning, and does not replace official requirements, test conclusions, or legal advice from target country regulatory authorities.