Can Test Reports Be Reused for Overseas Registration of Imaging Equipment?

Can Test Reports Be Reused for Overseas Registration of Imaging Equipment?

Whether test reports can be reused for overseas registration of imaging equipment is not a simple yes or no. It requires a case-by-case assessment based on the target country's regulatory rules. First, confirm whether the device falls under that country's medical device regulatory scope, then determine the registration pathway and applicant based on risk classification. For foundational test reports such as electromagnetic compatibility (EMC), electrical safety, and biocompatibility, reuse is generally possible if the laboratory has appropriate qualifications and the standards align with target country requirements. However, if the target country imposes additional requirements on standard versions, test conditions, or local clinical evidence, supplemental testing or new reports may be necessary.

Applicable Scenarios and Core Questions

Manufacturers of imaging equipment often ask: “We have already conducted testing in China or the EU; can we submit those reports directly to the target country's regulatory authority?” This question involves product classification, standard differences, laboratory qualifications, technical documentation completeness, and registration strategy. It cannot be answered with a simple “yes” or “no.”

Test reports commonly considered for reuse include EMC, electrical safety (IEC 60601 series), performance testing, biocompatibility (ISO 10993), software verification, and cybersecurity. These reports are essential components of the technical file. During regulatory review, authorities will scrutinize the authenticity, applicability, and validity of these reports.

The core issues are whether the target country recognizes the original testing laboratory's qualifications, whether the test standards align with the target country's current standards, whether the product models and configurations covered in the reports encompass all registration units, and whether the reports remain within their validity period.

Different countries have different registration pathways for imported medical devices. Some accept CB scheme or MDSAP audit reports, while others require local testing or reports issued by designated laboratories. Companies may submit applications simultaneously in GHWP member states, Southeast Asia, the Middle East, Latin America, and other markets. Therefore, it is essential to first build a core test report library and then perform localized conversion according to each country's requirements.

Registration Judgment Logic

To determine whether test reports can be reused, follow the logical sequence below.

Step 1: Confirm Product Scope

Confirm whether the product falls under the target country's medical device regulatory scope. Some imaging equipment may be classified as radiology devices, software as a medical device, or in vitro diagnostic devices, each with different registration requirements and test standards.

Step 2: Confirm Risk Classification and Registration Pathway

For example, Class I products may only require self-declaration, while Class II and III products require substantive review. Some countries also require on-site inspections or quality management system audits.

Step 3: Assess Existing Documentation

Existing NMPA registration certificates, CE technical files, FDA 510(k) or PMA files, ISO 13485 and MDSAP certificates serve as the foundation for reusing test reports.

Step 4: Match Test Standards Item by Item

Confirm whether the target country adopts IEC standards or local standards, whether specific standard versions are mandatory, and whether there are national differences (e.g., Japan, Brazil, and Saudi Arabia often add deviations to IEC standards).

Step 5: Confirm Laboratory Qualification Requirements

If the target country requires that test reports be issued by a locally designated laboratory, or requires ISO/IEC 17025 accreditation with ILAC mutual recognition, the original laboratory's qualification may be insufficient.

Step 6: Define Localization Conversion Content

Test reports themselves can be translated or issued in English, but labels, instructions, voltage, plugs, and network interfaces must comply with target country requirements, which often require additional testing or declarations.

Ultimately, the company should create a “Test Report Reuse Assessment Form” listing the acceptable standards and supplemental testing requirements for each target country to guide registration submissions.

Documentation and Evidence

Reuse of core test reports requires a complete technical documentation evidence chain. Regulators look not only at the reports themselves but also at the quality system and testing conditions underlying them.

Prepare the following documentation:

• Original or notarized copies of test reports
• Laboratory qualification certificates
• Test standard versions
• Description and photos of tested samples
• Product technical requirements or performance specifications
• Risk management files
• Statements explaining any differences not reflected in the reports

If reusing NMPA test reports, note that domestic reports usually contain product technical requirements, test methods, results, and conclusions, but may lack a complete mapping to IEC standards. In such cases, prepare a difference analysis table explaining the correspondence between domestic standards and IEC standards.

When reusing CE reports, if the report was issued by a laboratory recognized by a notified body and conforms to relevant harmonized standards, most countries will accept it. However, some countries require a CB test certificate or CB report. In that case, ensure the laboratory is an IECEE-recognized CB testing laboratory.

For FDA reports, common practice is to use the test summaries and full reports referenced in the FDA 510(k). Confirm that the test standards cover all items required by the target country. For example, the FDA may accept IEC 60601 Edition 3, but the target country may still require testing for certain cybersecurity features.

For GHWP member state mutual recognition mechanisms, such as Thailand, Malaysia, and Singapore, reports from other countries may be accepted, but usually require an English version and verification of the original report. Therefore, prepare English reports in advance and confirm the verification method.

Quality system evidence is also important. ISO 13485 certificates, MDSAP certificates, or system audit reports recognized by the target country enhance the credibility of test reports. In addition, the local authorized representative's authorization document and proof of the registration certificate holder are necessary.

Common Errors

• Submitting non-English test reports without translation, making it impossible for reviewers to verify.
• Failing to check whether the models and accessories in the test report cover all registration units, often resulting in “the main unit has a report, but the probe or software does not.”
• Ignoring the target country's power voltage and plug standards, e.g., 120V/60Hz in the US, 100V/50/60Hz in Japan, and 230V/50Hz in the Middle East, leading to mismatched submitted reports.
• Assuming that ISO 17025 laboratory reports are valid in all countries, while some countries only accept reports from their own or specific countries.
• Not updating expired test reports, especially when standards have been revised without timely assessment of differences.
• Confusing the role of clinical evaluation and test reports, assuming that having test reports eliminates the need for clinical evidence, especially for high-risk functions such as AI-assisted diagnostic software.
• Ignoring the local authorized representative's responsibility for test reports; the representative cannot provide valid explanations, leading to review deficiencies.
• Reusing high-risk certification materials without first assessing the target country's registration pathway, resulting in application rejection or requests for extensive additional information.

Company Preparation Checklist

• Establish a core test report inventory including report number, test standard, sample description, validity period, and applicable markets.
• Verify the laboratory qualifications of all test reports and obtain qualification certificates in English.
• Create a standard difference comparison table, mapping domestic, CE, and FDA standards against target country national standards item by item.
• Prepare technical documentation difference statements for already registered products, especially software version and cybersecurity updates.
• Confirm with the local authorized representative in advance regarding report submission format, translation requirements, and acceptance of electronic versions.
• Assess whether supplemental testing is needed and arrange for difference testing at laboratories recognized by the target country when necessary.
• Prepare localized versions of labels, instructions, and packaging, and maintain version control records.
• Communicate with notified bodies or competent authorities about the feasibility of reusing test reports and obtain preliminary opinions.
• Develop a post-market surveillance plan that includes product change control processes linked to test reports.
• For multi-country registration plans, centrally manage registration files and test reports to facilitate future updates.

AIMEILI Regulatory Interpretation and Business Impact

From a regulatory consulting perspective, the most common mistake is assuming that “having a test report means everything is covered.” In reality, a test report is only one part of the technical file. Review authorities focus more on the match between the report, the target country's regulatory requirements, and the actual state of the product.

We recommend conducting a “Test Report Reuse Feasibility Assessment” in the early stage of a project. Spend 2 to 3 weeks reviewing the existing report library against the admission requirements of 3 to 5 target countries to create a difference list. This approach helps avoid discovering missing core tests in the middle of registration, which could cause overall delays.

Reusable documents generally include generic test reports such as basic electrical safety, EMC, biocompatibility, and reliability testing. What must be localized are labels, instructions, operating language, power adaptation, wireless certifications, and clinical data. Especially for functions involving AI algorithms and image processing, local clinical validation may be required.

The local authorized representative and certificate control are critical. Many countries require that the registration certificate be held by a local representative. The stability of the representative directly affects certificate maintenance and change applications. Companies should sign clear representative agreements covering report submission, review communication, certificate renewal, and transfer clauses upon termination.

For multi-country registration, strive to achieve “one test, multiple submissions” by selecting internationally recognized testing laboratories and standards. However, remember that a CB report is only a foundation; some countries still impose local difference tests, so reserve time and budget.

After market launch, if the product undergoes software upgrades, replacement of EMC-related components, or standard revisions, promptly assess whether the original test reports remain valid. If necessary, initiate a change registration or update submission; otherwise, certificate continuity may be affected.

Frequently Asked Questions

Do test reports have a validity period? When must retesting be done?

There is generally no uniform validity period for test reports. However, when standards are revised, companies must confirm whether the standards referenced in the reports are still accepted by the target country. If a standard has been replaced with substantive changes, supplemental testing may be required. Additionally, review authorities may require that reports be issued within the last 2 years, and some countries may be stricter. It is advisable to maintain records of standard versions and product changes, and periodically assess report currency.

Can a CB report completely replace local testing?

The CB scheme can reduce costs, but many countries impose national difference tests, such as voltage, plugs, and software interface. Moreover, a CB report must be issued by an IECEE-recognized CB laboratory, and the certificate holder must ensure that the product model and certification scope in the report are consistent. Therefore, a CB report is not a universal substitute. Confirm in advance whether the target country participates in the CB scheme and what national differences apply.

If the model in the test report differs from the registration model, can the report still be reused?

If the test report covers only the basic model and the registration model is a derivative or series model, verify whether the core technical parameters are identical. Generally, coverage can be achieved through a “test report plus difference statement,” but the statement must detail product structure, performance, and software changes, and include a risk assessment. If changes are substantial, difference testing or a new report may be required.

Continue Reading

For related topics, see the following articles:

• Can Test Reports Be Reused for Overseas Registration of POCT Products?
• How to Select a Local Authorized Representative for Overseas Registration of Imaging Equipment?
• What Are Common Reasons for Supplementary Materials in Overseas Registration of Imaging Equipment?
• How to Manage Post-Market Surveillance for Overseas Registration of Imaging Equipment?
• When Is a Change Registration Required for Overseas Registration of Imaging Equipment?
• How to Group Multiple Models for Registration of Imaging Equipment?