How to Prepare Performance Verification Documentation for Overseas Registration of Rehabilitation Devices?

This article provides a systematic approach to preparing performance verification documentation for overseas registration of rehabilitation devices. It emphasizes that such documentation is not simply a collection of test reports; manufacturers must first determine whether the product falls under the medical device regulatory scope in the target country, then assess the risk class and registration pathway. The article also highlights the importance of leveraging existing NMPA, CE, FDA, ISO 13485, or MDSAP documentation, and recommends integrating the process into a multi-country market access strategy.

Key Summary

For overseas registration of rehabilitation devices, performance verification documentation should be based on a clear regulatory determination rather than a compilation of existing reports. The manufacturer must first confirm whether the target country regulates the product as a medical device, then determine its risk class and registration route. Different countries categorize rehabilitation devices differently; for example, massage therapy devices, exercise training devices, and walking assist devices may fall under different regulatory categories. Before preparing performance verification documents, systematically review existing NMPA, CE, FDA, ISO 13485, or MDSAP files to identify what can be reused and what requires localization.

The core evidence chain includes product technical requirements, performance test reports, risk management documentation, clinical evaluation or clinical evidence, labeling and instructions for use, and local agent or authorized representative information. A common oversight is failing to align performance verification methods with the test standards accepted by the target market. Multi-country registration also demands attention to technical file variations and the risk of request for amendments. A post-market maintenance plan is part of the registration dossier and must be established in advance.

For Chinese medical device companies, a prudent approach is to start with product classification and a gap assessment of existing documentation, then decide whether NMPA, CE, FDA, ISO 13485, or other market files can be reused. Target market registration affects technical files, authorized representatives, importer coordination, label language, quality system certificates, and future change control. If a company simply proceeds with a checklist of documents, it may encounter amendments or rework due to model coverage, evidence chain consistency, label claims, and certificate ownership.

AIMEILI recommends integrating this matter into a unified GHWP member state and multi-country market access strategy, using a single set of reusable core technical documents to support local adaptation across different markets, rather than recreating dossiers from scratch for each country.

Applicable Scenarios and Core Issues

Overseas registration of rehabilitation devices is a systematic project, especially for companies planning to enter GHWP member states, Southeast Asia, the Middle East, or Latin America. The preparation of performance verification documentation directly determines the success or failure of registration. In this article, rehabilitation devices include but are not limited to physical therapy equipment, exercise rehabilitation equipment, cognitive rehabilitation equipment, walking assist devices, pressure therapy equipment, and electrical stimulation devices. These products often sit between medical devices and ordinary consumer goods, making regulatory classification prone to error.

The first question a company must answer is not “Which reports should I submit?” but “Does my product fall under the medical device definition in the target country?” For example, a low-frequency therapeutic device may be a Class II medical device in the United States, but in some Middle Eastern countries it may be regulated as a health device, while in certain Southeast Asian countries it could be classified as a conventional medical device. Misclassification can invalidate all downstream documentation and waste time and budget.

Another core issue is that performance verification documentation is not the entire registration submission. It must form an evidence chain with the technical file, risk management, clinical evaluation, labeling, and quality management system documents. Performance verification only proves that the product achieves its intended performance, but the intended performance itself must be derived from risk analysis and clinical needs.

Registration Decision Logic

Overseas registration of rehabilitation devices should follow a three-step decision process instead of directly reusing existing reports.

Step 1: Determine whether the product falls under the target country's medical device regulatory scope. Review the medical device definition in the target country's regulations, and check the intended use, working principle, and whether the product has medical functions. For example, an ordinary treadmill is not a medical device, but a rehabilitation treadmill with ECG monitoring and exercise prescription functions may be a medical device.

Step 2: Determine the risk class, registration pathway, and applicant entity. Most countries classify rehabilitation devices into Class I, II, and III based on risk, with different routes such as registration/notification, declaration of conformity, substantive review, or pre-market approval. The company must confirm whether the applicant is a local manufacturer or a foreign applicant, and whether a local agent or authorized representative is required. Some countries require performance verification reports to be issued by local laboratories or to meet local testing standards.

Step 3: Assess whether existing NMPA, CE, FDA, ISO 13485, MDSAP, or other market documentation can be reused. Create a documentation mapping table that compares existing test reports, design verification records, and risk management files against the target country's requirements. For reusable files, keep the original raw data; for localizable files, rewrite or supplement testing as needed.

Only after these steps can a company define the technical documentation, performance verification, risk management, clinical evaluation or evidence, labeling, local agent, authorized representative, and post-market surveillance requirements, forming a complete project plan.

Documentation and Evidence

Performance verification documentation typically comprises four layers: core performance indicators, test methods, test results, and conclusions. The company must first define the product's key performance parameters, such as output frequency, pulse width, therapeutic temperature, force range, and software response time. Each parameter corresponds to one or more tests, which should be based on recognized standards or validated in-house methods.

Common reference standards include IEC 60601 series for safety, specific product standards (e.g., IEC 60601-2-x), ISO 14971 for risk management, ISO 10993 for biocompatibility, IEC 62304 for software lifecycle, and various mechanical, electrical, and electromagnetic compatibility standards. Companies cannot simply translate CE reports and submit them to other countries, as different markets have varying requirements for test laboratory qualifications, sample sizes, test environments, and result acceptance criteria.

For GHWP member states or multi-country registration, it is recommended to build a “core technical file package” that consolidates basic performance data, design inputs and outputs, and risk assessment for the same product, and then generate country-specific appendices for each target country. This approach reduces duplicate work and facilitates quick file retrieval and resubmission during amendments.

Clinical evaluation or clinical evidence is an important complement to performance verification. For novel rehabilitation devices with insufficient published literature, clinical trials or clinical investigations may be required. When preparing clinical documentation, follow the target country's clinical evaluation guidelines and clearly define the indicated population, evaluation endpoints, and statistical methods.

Labeling and instructions for use cannot be prepared separately from performance verification. Performance parameters, target populations, and contraindications in the labeling must be consistent with the test reports. Target language versions must be translated by professionals and legally reviewed by a local agent or consultant.

Quality management system evidence is directly related to performance verification. Performance test records should be generated under an ISO 13485 or MDSAP-compliant quality system, with complete raw records, equipment calibration records, and operator qualifications. If the target country requires a factory inspection or quality system certificate, arrange this in advance.

Common Mistakes

• Not conducting a regulatory classification assessment first, applying for non-medical devices as medical devices, or selling medical devices as non-medical devices.
• Simply reusing CE or FDA reports without verifying the target country's recognized standards, test laboratory qualifications, and language requirements.
• Incomplete definition of performance indicators, focusing only on a single parameter and neglecting environmental adaptability, repeatability, durability, and software function verification.
• Disconnection between risk management documentation and performance verification; risk control measures identified in the risk analysis are not proven effective through testing.
• Insufficient clinical evaluation content, submitting a literature review as clinical evidence without a systematic evaluation of the product's indications.
• Inconsistency between labeling/IFU and performance reports, leading to review questions.
• Unclear responsibilities of local agent or authorized representative, ignoring their critical role in amendment communication and post-market supervision.
• Missing a post-market performance monitoring plan, without a process for complaint analysis and annual updates.

Company Preparation Checklist

• Establish a list of target country regulations, confirming the product's regulatory classification, registration pathway, and applicant entity.
• Review existing NMPA, CE, FDA, ISO 13485, and MDSAP files and create a gap analysis table.
• Define the product's key performance indicators and set acceptance criteria in the design input file.
• Prepare performance verification protocols and reports, ensuring test methods, test conditions, and sample sizes meet target country requirements.
• Complete the risk management report and establish the correspondence between risk control measures and test results.
• Compile clinical evaluation or clinical evidence documents; add clinical studies if necessary.
• Create target language labeling and IFU, and have regulatory personnel review for consistency.
• Appoint a local agent or authorized representative, sign an agreement, and clarify certificate ownership and change notification obligations.
• Establish a post-market surveillance plan and an annual update process, including complaint handling, adverse events, and performance tracking.
• Engage or consult with regulatory consultants experienced in local registration, and conduct mock reviews before submission.

AIMEILI Perspective

From a regulatory consultancy perspective, rehabilitation device companies most often misjudge that “my product is technically simple, so performance verification should not be too complex.” In fact, rehabilitation devices directly contact patients and often include energy output, movement assistance, or biofeedback functions, so the safety and effectiveness evidence requirements are not low. If a company fails to conduct a market access feasibility assessment in the early stage of the project and only discovers a wrong registration pathway after testing is complete, the rework cost is extremely high.

We recommend that after determining the target market, the first step is to carry out a gap analysis, mapping existing documentation country by country, and identifying what can be used directly, what requires additional data, and what must be redone. Notably, clinical evaluation and labeling localization are the most underestimated areas. Many companies simply translate CE documents into the local language, ignoring differences in local epidemiology, target populations, and clinical usage habits.

Regarding local agents and certificate ownership, companies must recognize that in many overseas markets, the certificate holder is the local representative or local legal entity. If an agent is chosen incorrectly, subsequent changes, renewals, and adverse event reporting can be hindered. The contract should clearly define the agent's confidentiality obligations, data access rights, and handover procedures upon termination.

For multi-country registration, we strongly advocate building a reusable technical file repository and organizing performance verification data using a unified logic. This allows quick generation of country-specific versions for GHWP countries, Southeast Asia, the Middle East, or Latin America, reducing duplicate work and amendment risk. Companies should also appoint a global registration lead to centrally manage timelines and communication records across countries, avoiding delays caused by information silos.

Frequently Asked Questions

Can performance verification for rehabilitation devices be entirely based on ISO standards?

Not necessarily. ISO standards are the basis for global harmonization, but the target country may mandate national or regional standards, such as EN standards or specific national deviations. Companies need to confirm the standard version, effective date, and additional test requirements, particularly for electrical safety and electromagnetic compatibility.

Can performance verification reports share raw data for multiple country registrations?

Raw data can be shared, but the report format and conclusions may need to be reorganized according to each country's requirements. Some countries accept full English reports, while others require a local language summary or a report issued by a local laboratory. It is recommended to maintain traceability of all original test records so that country-specific versions can be generated at any time.

If there is no clinical data, can registration be completed through performance verification alone?

This depends on the product's risk class and intended use. Low-risk rehabilitation devices with adequate literature support and non-invasive use may not require new clinical trials, but a systematic clinical evaluation is needed. For medium-risk devices, if equivalent products are already on the market, equivalence arguments may eliminate the need for trials. High-risk devices still require clinical data.

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This article was prepared based on AIMEILI's registration practice database, the medical device international registration knowledge base, and publicly available regulatory information. Specific projects should be based on the latest requirements of the target country's regulatory authority and the product documentation. Published on 2026-08-16 21:35, updated on 2026-08-16 21:35.