Technical Documentation
Review product descriptions, design information, specifications, verification and validation, and related materials as the basis for preparing the Japanese application form and STED.
How to Use CE Marking Documentation for Medical Device Applications in Japan
EU MDR Technical Documentation, GSPR Checklists, Clinical Evaluation Reports (CERs), risk management documentation, test reports, and similar materials may also be useful when preparing a medical device approval or certification application in Japan.
However, having obtained CE marking does not in itself mean that the product complies with Japanese regulatory requirements.
The relationship between existing EU documentation and Japanese requirements should be mapped, and any gaps should be identified based on the product scope to be submitted in Japan.
Map EU MDR Documentation to Japanese Application Requirements
First, define the intended use, models, specifications, accessories, and manufacturing sites that will be included in the Japanese application.
Then review how each document prepared for the EU supports the Japanese application form, STED, Essential Principles, clinical evaluation, labeling, and other application elements.
The EU and Japan differ in areas such as:
- Generic name
- Class
- Application route
- Application category
- Documentation structure
- Labeling requirements
Even when the same test report is used, it is necessary to explain why the results can be applied to the product being submitted in Japan.
Main Correspondence Between EU MDR and Japanese Application Documents
GSPR Checklist
Review applicable requirements, standards, and supporting documentation and map them to the Japanese Essential Principles conformity checklist.
Clinical Evaluation Report
Review the relationship between the report and the intended use, target patients, comparator, literature, and clinical data relevant to the Japanese application.
Risk Management File
Review hazards, risk control measures, residual risks, and consistency with Japanese test documentation, labeling, and precautions for use.
Verification / Validation
Confirm the test standards, specimens, worst-case conditions, and acceptance criteria, and assess whether the results can be applied to the product being submitted in Japan.
Labeling / IFU
Organize statutory labeling, package inserts, Instructions for Use, and related materials according to the intended use submitted in Japan and Japanese labeling requirements.
Six Items to Confirm Specifically for Japan
Generic Name and JMDN Code
Do not rely on the EU product name or class. Compare the product characteristics with the definition of the applicable Japanese generic name.
Class and Application Route
Confirm the Japanese class and applicable certification standards and determine whether the product requires a marketing notification, certification, or approval.
Application Category and Comparator
For approval applications, organize the application category—new, improved, or generic—and the comparison strategy against approved products.
Intended Use and Product Specifications
Compare the EU Intended Purpose with the intended use, target patients, and product specifications that will be submitted in Japan.
Standards and Notifications
Confirm the applicable scope and versions of JIS, ISO, IEC, notifications, and other standards referenced in the Japanese application compared with those used in the EU.
Manufacturing Sites and QMS
Confirm consistency between the manufacturing sites and processes described in the EU documentation and the Japanese application, registrations, and QMS documentation.
From Review of EU Documentation to Preparation of Japanese Documents
- 01
Define the Product Scope for Japan
Confirm the intended use, target patients, models, accessories, specifications, and manufacturing sites.
- 02
Confirm the Latest Versions of EU Documentation
Confirm the versions of the Technical Documentation, GSPR, CER, risk management documentation, test reports, labeling, and other relevant documents.
- 03
Map the EU Documentation to Japanese Application Elements
Organize which documents will support the Japanese application form, STED, Essential Principles, clinical evaluation, and other application elements.
- 04
Identify Differences Between the EU and Japan
Review differences in intended use, product scope, standards, comparators, test specimens, manufacturing processes, and other relevant items.
- 05
Identify Missing Explanations and Documentation
Identify Japan-specific requirements and areas that cannot be adequately explained using the existing documentation alone.
- 06
Cross-Check the Entire Japanese Submission
Confirm that terminology, versions, and conclusions are consistent across the application form, STED, test data, clinical evaluation, QMS documentation, labeling, and related materials.
Points Commonly Overlooked When Reusing EU Documentation
- Applying the EU class directly to Japan
- Treating an EU product code as a JMDN code
- Failing to confirm differences in intended use
- Failing to confirm differences between test specimens and the Japanese application product
- Using different versions or scopes of standards without review
- Failing to confirm whether the CER comparator is appropriate for the Japanese application
- Inconsistencies in document versions or product names across multiple documents
Related guides: Medical Device Registration & Market Entry in Japan | Preparing a Medical Device STED in Japan
Which CE and EU MDR Documents May Be Reused for a Japan Application?
A foreign manufacturer does not normally need to recreate every technical document from the beginning when preparing a medical device application for Japan. Existing EU MDR documentation can often serve as source evidence, but each document should be reviewed against the Japanese product scope, regulatory pathway and submission requirements.
EU MDR Technical Documentation
The EU MDR technical documentation can provide useful source information on the device description, intended purpose, design, manufacturing information, specifications and verification and validation activities.
For Japan, however, the information needs to be reorganized to match the Japanese application form, STED and supporting documentation. Differences in intended use, model configuration, accessories, specifications or manufacturing sites should be identified before the Japanese submission package is prepared.
GSPR Checklist
An EU MDR General Safety and Performance Requirements (GSPR) checklist can help identify the standards and evidence already used to demonstrate conformity in Europe.
It does not replace the Japanese Essential Principles conformity assessment. The Japanese Essential Principles should be assessed separately, and the supporting standards, test reports and risk controls should be mapped to the applicable Japanese requirements.
Clinical Evaluation Report and PMCF Data
A Clinical Evaluation Report (CER), clinical literature, PMCF information and other clinical evidence prepared for Europe may be useful when evaluating the clinical evidence available for Japan.
Their usability depends on whether the Japanese intended use, patient population, clinical setting, device configuration and claims are sufficiently aligned with the evidence. Additional analysis, literature review or clinical data may be required depending on the product and application category.
Risk Management File
Risk management documentation prepared under ISO 14971 can provide an important basis for the Japanese submission.
The risk analysis should nevertheless be reviewed against the product configuration, intended use, labeling and risk-control measures proposed for Japan. Changes made after the original EU assessment should also be reflected.
Verification and Validation Test Reports
Existing performance, biocompatibility, electrical safety, EMC, sterilization, packaging, shelf-life, software, cybersecurity and usability reports may be usable for Japan.
Before relying on them, confirm that the tested device represents the Japanese application product and that the test method, standard edition, acceptance criteria and test conditions remain appropriate.
For a detailed overview, see:
EU Labeling and Instructions for Use
EU labels and instructions for use can be useful source documents, but they cannot simply be transferred to the Japanese market without review.
The Japanese labeling and package insert must be prepared in accordance with the Japanese approval, certification or notification details and the applicable Japanese labeling requirements.
QMS Documentation
Existing ISO 13485 and EU MDR quality-system documentation may support preparation for Japan.
However, the manufacturer should separately confirm the scope of the Japanese QMS requirements, the relevant manufacturing sites and the documents required for the applicable QMS conformity inspection.
Perform a Japan Gap Assessment Before Ordering Additional Tests
One of the most important steps for a foreign manufacturer is to review the existing technical documentation before commissioning new testing for Japan.
A practical gap assessment can follow this sequence:
1. Confirm the exact device, models, accessories and configurations to be marketed in Japan.
2. Confirm the Japanese generic name, JMDN code, classification and regulatory pathway.
3. Compare the Japanese intended use and specifications with the EU-approved device.
4. Map the Japanese Essential Principles to the available standards and evidence.
5. Inventory existing verification and validation reports and confirm the applicable standard editions.
6. Confirm whether the tested samples represent the final Japanese product.
7. Review available clinical evidence and identify any unresolved clinical questions.
8. Confirm the MAH or DMAH structure, foreign manufacturer registration and QMS scope.
9. Identify issues that may require PMDA consultation.
10. Only after these steps, determine which additional tests or documents are actually necessary.
This approach helps avoid repeating tests that can be supported by existing evidence while identifying Japan-specific gaps before they affect the submission schedule.
Documents to Collect Before Starting the Japan Submission
Before the Japan project begins, foreign manufacturers should collect the latest versions of the documents that may be relevant to the Japanese application.
Typical documents include:
- current EU MDR Technical Documentation index
- Declaration of Conformity and CE certificate, where applicable
- GSPR checklist
- device description and intended-purpose documentation
- risk management file
- product specifications and drawings
- verification and validation reports
- biological safety documentation
- electrical safety and EMC reports, where applicable
- sterilization validation and residual testing, where applicable
- packaging and shelf-life validation
- software life-cycle documentation, where applicable
- cybersecurity documentation, where applicable
- usability engineering documentation, where applicable
- Clinical Evaluation Report and relevant clinical evidence
- current labeling and instructions for use
- manufacturing-site information
- ISO 13485 and relevant quality-system documentation
- product change history
The purpose of collecting these documents is not to submit the complete EU file unchanged. It is to determine which evidence can support the Japanese application, which information needs to be reformatted or supplemented, and which genuine evidence gaps remain.
Official Sources
For the EU MDR framework and Japan's medical device approval requirements, refer to the following primary sources.
Contact Us About Using CE Marking Documentation for a Japanese Application
We review the existing EU documentation and identify what can be used as-is in Japan, what requires additional explanation, and what additional documentation should be prepared.
Contact us about a Japanese medical device application