Supporting Documents and STED Format in Medical Device Applications

The wave of globalization in the medical device industry has brought significant transformation to the application process. With the transition from the Pharmaceutical Affairs Act to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (commonly known as the Pharmaceuticals and Medical Devices Act or PMD Act, formally titled “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices”), the term “Summary of Supporting Documents” was renamed to “Supporting Documents.” This change represents more than a mere nomenclature update; it carries significant meaning in terms of conformity with international standards.

This change was officially established by Notification No. 9 dated January 20, 2015 (Heisei 27) from the Councilor of the Pharmaceutical Affairs and Food Sanitation Bureau. It represents an important initiative aimed at achieving three key objectives: enhancing international regulatory harmonization, standardizing application materials, and improving the efficiency of the review process.

What is STED Format?

The introduction of STED (Summary Technical Documentation) format represents a revolutionary change in medical device applications. This format was agreed upon at the Global Harmonization Task Force (GHTF) and is recognized as a global standard format for technical documentation. It should be noted that GHTF concluded its activities in 2011, and its role was transferred to the International Medical Device Regulators Forum (IMDRF), which continues to promote international harmonization of medical device regulations.

In Japan, applications using STED format have been accepted since 2005 and are positioned as part of medical device applications. Documents in STED format include comprehensive and structured content as follows:

Key Components of STED

Section	Main Content
Device Summary	Overview of the application item, development background, comparison with similar medical devices, usage status in foreign countries, regulatory authority decisions on safety, etc.
Conformity to Essential Principles	Clarification of conformity status to essential principles through declaration of conformity, checklists, list of reference standards, etc.
Detailed Device Information	Detailed description of technical information including raw materials, performance and safety standards, manufacturing methods, quality control methods, etc.
Design Verification and Validation Documents	Presentation of test data supporting safety and performance, clinical trial data as necessary

This structure enables systematic explanation of medical device characteristics and conformity, improving transparency and efficiency of applications.

Application Categories and STED Requirements

Medical device application categories are classified into the following five types based on evaluation results of differences from existing similar medical devices:

Application Category	Main Requirements
New Medical Device	Detailed explanation of development background and technical features, comprehensive safety and efficacy data
Improved Medical Device (with clinical trials)	Explanation of differences from existing devices, evaluation of impact of changes, clinical trial data
Improved Medical Device (without clinical trials)	Explanation of differences from existing devices, evaluation of impact of changes, non-clinical test data
Generic Medical Device (identical)	Presentation of data demonstrating identity with existing devices
Generic Medical Device (substantially equivalent)	Presentation of data demonstrating equivalence with existing devices

Depending on the application category, the level of detail required for documents attached to the manufacturing and marketing approval application varies.

Important Considerations in Practice

The following points are important when preparing documents in STED format:

Maintaining Consistency

Consistency in descriptions across sections, unification of terminology, and appropriate management of reference documents are required. In particular, consistent explanations without contradictions among the approval application itself, STED, and supporting materials are necessary.

Supporting Data

When claiming performance or safety, it is necessary to clearly demonstrate the correspondence with supporting test data. Traceability to test results and evidence must be secured, with appropriate citations supporting claims.

Alignment with Risk Management

Alignment with the Risk Management File is crucial. Currently, ISO 14971 (latest version is the third edition published in 2019) applies to risk management for medical devices. In Japan, the corresponding JIS T 14971:2020 has been established, and according to Notification No. 1224001 dated December 24, 2020 from the Pharmaceutical Evaluation Division, the revised JIS applies to new applications submitted after September 30, 2021 (Reiwa 3).

Particular attention should be paid to the following points:

• Clarification of risk control measures for identified hazards and hazardous situations
• Presentation of evaluation rationale for residual risks and judgment of acceptability
• Implementation and documentation of risk-benefit analysis
• Continuous implementation of post-market risk management

Additionally, when medical device software is included, conformity to IEC 62304 (Medical device software – Software life cycle processes) is also required. IEC 62304 specifies three fundamental principles for improving software safety: “risk management (ISO 14971), quality management (ISO 13485), and software engineering.”

Requirements According to Classification

Depending on the medical device classification (Class I general medical devices, Class II controlled medical devices, Class III/IV specially controlled medical devices), the level of detail required for information varies. Higher-risk devices require more detailed information.

Utilizing PMDA Consultation System

By utilizing the pre-application consultation system provided by the Pharmaceuticals and Medical Devices Agency (PMDA), it is possible to share understanding with regulatory authorities before application. This system contributes to improving application quality and review efficiency. Early consultation is particularly recommended for new medical devices or products with high technical novelty.

Practical Approach to Creating High-Quality Supporting Documents

To ensure the quality of supporting documents, the following practices are important:

Establishing Document Management System

• Appropriate management of version numbers and revision history
• Clear citation of references and ensuring accessibility
• Regular review and updates of content
• Verification of consistency among approval application, STED, and supporting materials

Conducting Internal Reviews

Through verification by the technical document management supervisor and validation of content appropriateness, document accuracy is improved. Mutual review by multiple experts is also effective.

Appropriate Management of Evidence

Appropriately cite evidence supporting claims, such as test results and literature data, ensuring traceability. Prepare supplementary materials in report format as necessary.

Ensuring Transparency

Honestly mention uncertainties and limitations, and indicate measures to address them. This transparency leads to building trust with regulatory authorities.

Through these efforts, the review process proceeds smoothly, and the success rate of applications increases.

The Future of Medical Device Applications

The introduction of STED format is an important step in the internationalization of medical device applications. With the transition from GHTF to IMDRF, regulatory harmonization is being advanced in a broader international framework. This format makes it easier for Japanese medical device manufacturers to expand into international markets, and through efficiency improvements in the review process, innovative products can be rapidly brought to market.

In recent years, medical devices in new technological areas have been increasing, including digital health technologies, medical devices utilizing AI (Artificial Intelligence), and SaMD (Software as a Medical Device). To address these, the regulatory framework is being continuously reviewed.

For all those involved in application practice, accurately understanding these changes and creating high-quality supporting documents will be key to future success. It is essential to stay informed of the latest regulatory trends and strive for document preparation that conforms to global standards. In particular, attention should be paid to revision trends in international standards such as ISO 14971 and IEC 62304, with timely responses being important.