Overall Summary of the Device
Explain the positioning of the device through its development history, overseas use, comparison with similar medical devices, and related information.
SUMMARY TECHNICAL DOCUMENTATION
Preparing a Medical Device STED in Japan
STED (Summary Technical Documentation) is a document used to organize the technical information required for a medical device approval application in Japan in a form that is easy to review.
It is important to connect the application form, test reports, Essential Principles, risk management, clinical evaluation, labeling, and other materials through one consistent explanation.
STED Connects the Application Content with Supporting Evidence
A STED does more than describe the product overview. It clarifies which supporting documents substantiate the intended use, specifications, safety, performance, clinical evaluation, and other aspects of the application.
Related guide: Using CE Marking Documents for Japan Medical Device Applications
The required documents and the depth of explanation vary depending on the application category and product characteristics.
If the STED is prepared independently from the other application materials, inconsistencies with the application form or test reports can easily arise. It is therefore important to review the entire application package in parallel.
Main Areas Addressed in a STED
Conformity with the Essential Principles
For each requirement of the Essential Principles, organize the applicable standards, evaluation methods, and supporting documents.
Device Information
Describe the intended use, structure and principle of operation, specifications, accessories, method of use, and related information.
Design Verification and Validation
Provide documentation supporting the application content for performance, safety, biological safety, sterilization, stability, software, clinical evaluation, and other relevant areas.
Precautionary Information
Organize warnings, contraindications and prohibitions, precautions for use, and the rationale for establishing them.
Manufacturing Information
Align manufacturing processes, manufacturing sites, sterilization, quality management, and related information with the application form and QMS documentation.
Points to Cross-Check Across the Application Form, STED, and Supporting Documents
Intended Use
Confirm that the target patients and clinical purpose are consistent across the application form, STED, clinical evaluation, and labeling.
Product Specifications
Confirm that the specifications, test methods, acceptance criteria, and test report results correspond to each other.
Product Configuration
Confirm that the models, sizes, and accessories included in the application can be supported by the submitted test and clinical data.
Risks and Precautions
Confirm that identified hazards, risk control measures, warnings, contraindications, and precautions for use correspond to each other.
Manufacturing Method
Confirm that the manufacturing sites and processes described in the application form are consistent with the STED, QMS, sterilization, and other supporting documentation.
Referenced Documents
Ensure that the relevant sections of test reports and standards-conformity documentation can be traced from the STED.
From Confirming Required Documents to the Final Cross-Check
- 01
Confirm the Application Category and Required Documents
Confirm whether the application is new, improved, or generic, the product characteristics, whether clinical study results are available, and other relevant factors.
- 02
Organize the Supporting Documentation
Confirm the latest versions of test reports, risk management documents, clinical documents, standards-conformity documentation, manufacturing documents, and other supporting materials.
- 03
Map Supporting Documents to Each STED Section
For each statement in the STED, identify the referenced document and the relevant section.
- 04
Check Consistency with the Application Form
Confirm consistency with the application form for the intended use, product specifications, product configuration, manufacturing method, and other key items.
- 05
Perform a Final Cross-Check of the Entire Dossier
Confirm terminology, versions, and conclusions across the STED, test reports, Essential Principles documentation, risk management, clinical evaluation, labeling, and other materials.
Common Points Overlooked When Preparing a STED
- Product names or specifications differ between the application form and STED
- The relationship between the tested model and the model under application is unclear
- Versions of standards or test reports do not match
- The supporting documents for the Essential Principles do not correspond to the STED explanation
- Risk management does not align with warnings and precautions for use
- The conclusion of the clinical evaluation does not match the intended use
- Manufacturing-site or manufacturing-process information differs from the QMS documentation
Frequently Asked Questions
Can We Request Preparation of the STED Only?
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Yes, but because the STED is closely related to the other application materials, consistency with the application form, test reports, and related documents must also be checked.
Can Overseas Technical Documentation Be Used?
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Some materials can be used. They should be mapped to the Japanese STED sections, and any missing explanations or Japan-specific requirements should be added.
When Should STED Preparation Begin?
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Starting after the main application strategy and required testing have been organized makes it easier to identify inconsistencies among the documents at an early stage.
Official Sources
For official information on medical device submission documentation and review materials in Japan, refer to the following PMDA sources.
You Can Consult Us About Approval Application Documentation
We support preparation of approval application materials, including the STED, and cross-check consistency with the application form, test documents, clinical evaluation, and related materials.
Approval, Certification & Notification Support