How Should Multiple Models of Rehabilitation Equipment Be Grouped in Overseas Registration?

Published: August 18, 2026 | Updated: August 18, 2026

Executive Summary

The key to grouping multiple models of rehabilitation equipment in overseas registration is to first determine whether the device is regulated as a medical device in the target country, and then to define the grouping logic based on risk classification and the applicable registration pathway. Manufacturers should prioritize reviewing existing NMPA, CE, FDA, ISO 13485, or MDSAP documentation to identify which technical files can be reused and which require localization. The common approach is to group products under the same manufacturer, same intended use, and same key technical characteristics, where differences are limited to model naming, dimensions, or accessories.

When preparing documentation, ensure that each model has corresponding performance verification data, risk management documentation, and labeling content, and clearly state the coverage relationship between the primary model and derived models. Common risks include grouping too broadly resulting in insufficient technical files, grouping too narrowly leading to increased duplicate submission costs, and neglecting the local agent's control over the certificate, change notification, and renewal obligations. GHWP member countries and markets in Southeast Asia, the Middle East, and Latin America often accept grouped submissions based on a common core design, but attention must be paid to local requirements for agent authorization, labeling language, and post-market surveillance.

Enterprises should complete a product classification and grouping strategy assessment early in the project, and avoid directly applying the domestic registration unit to overseas filings to prevent subsequent corrections or rejections.

Applicable Scenarios and Core Questions

Rehabilitation equipment includes physical therapy devices, rehabilitation trainers, walking aids, electrical stimulators, and more. Most are medical devices, but regulatory boundaries differ by country. For example, some relaxation massage devices may not be considered medical devices in certain countries, while in others they are regulated as Class II or Class III. Before filing, companies must confirm whether the target market regulates the product as a medical device.

Multi-model grouped submissions typically occur when a single manufacturer generates multiple models based on the same core technology platform, such as different sizes, colors, voltage versions, or accessories. These models are highly similar in structural composition, working principle, and intended use, and companies wish to include them in a single registration application to save time and cost.

The core issue is not whether grouping is possible, but rather whether the grouping is compliant, evidence is sufficient, and follow-up maintenance is controllable. Most regulators allow grouping, but have strict requirements on the logic and evidence. If the grouping is too broad, reviewers may determine that the risks of all models cannot be covered; if too narrow, the purpose of grouped submission is lost.

Companies need to identify the differences of each model and assess whether these differences affect safety or effectiveness. If differences are only in appearance, packaging, or non-critical component materials, they can usually be grouped into one registration unit. If differences involve primary functions, output parameters, intended body parts, or clinical expectations, separate submissions may be required.

Another easily overlooked issue is the concept of a primary model in grouped submissions. Some countries require designation of a primary model and justification of equivalence for other models. If the primary model is chosen poorly, all technical data for the series may be rejected.

Therefore, companies should complete a scenario analysis before project initiation, list all models intended for registration, complete a model difference table, and preliminarily assess the regulatory definition in each country.

Registration Assessment Logic

The first step is to determine whether the product is regulated as a medical device in the target country. If not, registration is not required, but local electrical safety or consumer protection regulations must still be met. Most rehabilitation devices are medical devices, but classification may range from Class I to Class IIb.

The second step is to determine the registration pathway based on risk classification. For example, under the EU MDR, non-active rehabilitation devices are often Class I or IIa, while active devices are often Class IIa or IIb; under the US FDA, most rehabilitation devices are Class II and require 510(k) submission; some Southeast Asian countries, such as Thailand and the Philippines, classify by risk into A/B/C/D categories.

The third step is to determine the applicant. Most countries require a local registrant or authorized representative to submit the application. If the company has no local entity, a local agent must be designated, and the agent will be responsible for post-market communication, adverse event reporting, and change notifications.

The fourth step is to assess the reusability of existing documentation. If the company already has an NMPA registration certificate, CE certificate, or FDA 510(k) clearance, most technical documents can be converted. However, note that review standards differ by country, especially regarding clinical evaluation and labeling language.

The fifth step is to confirm the technical documentation list. In addition to basic descriptions, manufacturers must submit a risk management report (ISO 14971), performance verification reports, electrical safety test reports (e.g., IEC 60601 series), electromagnetic compatibility test reports, software lifecycle documentation (if software is included), and biocompatibility reports (if the device contacts the human body).

The sixth step is to develop a grouping strategy. The general principle is that models within the same registration unit must have the same intended use, the same or similar working principle, and the same key safety characteristics. Companies need to prepare a model coverage statement detailing the differences between the primary model and derived models, and prove that these differences do not affect safety and effectiveness.

Finally, initiate multi-country registration. GHWP member countries have achieved some harmonization, but local differences remain. The recommended approach is to use a core documentation package plus localized files, first preparing a benchmark file and then adjusting according to each country's requirements.

Documentation and Evidence

Core materials for grouped submissions include product technical requirements, a model list, and a difference analysis table. Each model should have a unique identifier, and correspond to a structural diagram, bill of materials, and working principle description.

Performance verification evidence should cover each model, or the difference analysis should prove that the primary model's data is representative of other models. For example, if models differ only in length, the primary model's mechanical strength test data may cover all lengths, but calculations or finite element analysis must be provided to demonstrate the worst-case scenario.

Risk management documentation should identify risks specific to each model. If a derived model uses a different battery or material, corresponding risk analysis and test data must be added.

Electrical safety and EMC testing are usually performed on a series basis. A representative model may be tested, but the selection rationale must be explained and test results must be confirmed to apply to all models. Some countries require a certificate for each model, so companies should confirm this in advance.

Labels and instructions for use must include all models. If model differences lead to different names, labels must list each one. The language of the instructions must comply with target country requirements. For example, many Middle Eastern countries accept Arabic and English, while Latin American countries require Spanish or Portuguese.

For clinical evaluation, clinical literature from similar products can be cited. However, if differences affect clinical outcomes, additional clinical data or literature may be required.

Local agent documentation includes the power of attorney, agency agreement, and contact information. Some countries require the local agent to hold relevant qualifications; companies should verify the agent's ability to fulfill regulatory obligations.

Post-market maintenance documentation includes vigilance systems, complaint handling procedures, and periodic update reports. These are not always fully submitted at the time of registration, but companies must establish the systems and explain how they will maintain each model.

Common Mistakes

• Directly applying the domestic registration unit to overseas submissions, ignoring local classification and grouping requirements.
• Grouping too broadly, placing all models into one application regardless of differences, leading to requests for extensive additional data and longer review cycles.
• Grouping too narrowly, splitting products from the same platform into multiple applications, resulting in duplicate testing and costs.
• Selecting an inappropriate primary model, not choosing the most complex or highest-risk model, causing other models to be uncovered.
• Technical documentation highlighting only the primary model without providing difference analysis for derived models, or difference analysis only describing appearance without safety justification.
• Neglecting multi-model coverage in labels and instructions, causing actual products to be inconsistent with registration files and leading to observations from regulators.
• Careless selection of a local agent, who fails to handle changes or renewals in a timely manner, causing the certificate to lapse.
• Failing to notify post-market changes, such as modifying model parameters or adding new models, without submitting the required change application.

Enterprise Preparation Checklist

• Complete product classification assessment for the target country and record the basis.
• Establish a complete model list, including all models intended for registration and future models.
• Prepare a model difference analysis table, explaining the differences between each model and the primary model.
• Confirm the primary model and prepare a coverage statement, including a worst-case justification if necessary.
• Organize reusable documentation such as existing domestic and overseas registration certificates, test reports, and quality system certificates.
• Fill gaps in safety verification, such as electrical safety, EMC, biocompatibility, and performance testing.
• Write risk management documentation covering the specific risks of all models.
• Prepare multilingual labels and instructions for use, and verify model information for each.
• Identify the local agent or authorized representative, sign an agreement, and clarify responsibilities.
• Check whether the target country has local testing requirements or requirements for local representation.
• Plan post-market maintenance, establishing channels for complaints and adverse event feedback.
• Set a project timeline, considering possible correction periods in each country's review process.

AIMEILI Regulatory Interpretation and Business Impact

A common misjudgment is believing that similar products can certainly be grouped. In reality, regulators review the completeness of the evidence chain and the argument that differences do not affect safety and effectiveness, not simple physical similarity. Companies often consider registration only after product design is finalized, leading to many tests that cannot cover all models and must be repeated at high cost.

Early in the project, a regulatory gap analysis should be performed. Translate the target country's classification, grouping rules, and technical documentation requirements into an internal checklist, then compare with existing documentation. This step may seem time-consuming but avoids repeated corrections later.

Which materials can be reused? Typically, quality management system certificates (ISO 13485), basic descriptions, principle explanations, most risk analyses, and test data based on the same core design. What must be localized? Labels, instructions, local agent information, the applicability of cited literature in clinical evaluation, and requirements regarding the qualifications of test report issuing bodies in certain countries.

A local agent is not just an intermediary that receives documents and forwards notifications. Certificates are often registered in the agent's name or held by the agent. If the agent is uncooperative, the company cannot even perform changes or renewals. This is particularly relevant in Latin American and Middle Eastern markets, where agent responsibilities and manufacturer authorizations are strictly scrutinized. Companies must clearly define certificate control, change timelines, and renewal obligations in the agreement.

For multi-country registration, we recommend using a set of benchmark technical documents as the backbone and placing each country's specific requirements into incremental files. This avoids duplicate preparation and allows quick orientation during corrections. The worst approach is to rewrite a completely different technical file for each country, which ultimately becomes unmaintainable.

Frequently Asked Questions

Question: Can models with different software and hardware versions be grouped in one submission?

If software version changes cause substantial differences in user interface or functionality, such as the addition of treatment modes or adjustment ranges, safety and effectiveness may be affected, and grouping into a single registration unit is not recommended. If only the internal algorithm is changed but output parameters remain the same, the software versions can be treated as two versions of the same model and explained in the documentation. For hardware versions involving component changes, equivalence justification must be provided.

Question: In multi-model submissions, does each model need to be tested individually?

Not necessarily. Most regulators allow testing a representative model, but a model coverage statement must be provided. Testing laboratories typically decide whether additional tests are needed based on the difference analysis. For example, if models only use different power plugs, only a power adaptability test may be needed; if dimensions or weights differ significantly, mechanical strength tests may be required. It is advisable to communicate with the target country's testing laboratory to confirm whether the representative model selection is acceptable.

Question: If a product already has a domestic registration certificate, can Chinese documentation be directly translated for multi-country registration?

No, it cannot be directly translated. Although the underlying content is similar, countries have different requirements for technical documentation format and depth. For example, the EU MDR requires more detailed clinical evaluation and post-market surveillance plans, the US FDA recognizes specific test report formats and accepts performance standards, and some Southeast Asian countries may require proof of marketing in the country of origin. Therefore, companies must reorganize domestic documentation into the target country's required format and update clinical evidence and risk management content.

Content Review and Applicability Boundary

Content Author: AIMEILI Regulatory Editorial Team

Professional Review: AIMEILI International Medical Device Registration Project Team

Source Principles: Priority is given to official regulatory agencies, international organizations, standard bodies, and publicly available regulatory materials; industry media and project experience are used only for supplementary judgment.

Applicability Boundary: This article is for preliminary understanding, documentation preparation, and project planning. It does not replace the official requirements of the target country's regulatory authority, testing conclusions, or legal advice.

Source: Compiled based on the AIMEILI registration practice question bank, the international medical device registration knowledge base, and publicly available regulatory information. Specific projects should follow the latest requirements of the target country's regulatory authorities and the product documentation basis.