STED Japan Medical Device: What It Is and How to Prepare It for PMDA

If you've been through the EU MDR process, you're already familiar with the STED (Summary Technical Documentation). Japan's PMDA uses a similar framework — but with important differences that can trip up manufacturers who assume the documents are interchangeable.

This article explains what STED means in the Japan regulatory context, how it differs from the EU version, and the key sections you need to prepare for a successful PMDA submission.

What is STED in the Japan Context?

In Japan, STED refers to the structured technical documentation submitted as part of a medical device approval application to PMDA. It is based on the IMDRF STED guidance (formerly GHTF), which Japan has adopted with modifications.

The STED serves as the primary technical dossier demonstrating that your device:

• Meets the Essential Principles of Safety and Performance (基本要件)
• Has been designed, manufactured, and tested to appropriate standards
• Has a favorable benefit-risk profile supported by clinical evidence

Japan STED vs. EU STED: Key Differences

While both are based on IMDRF guidance, there are important differences:

Aspect	Japan STED (PMDA)	EU STED (MDR)
Language	Japanese required for most sections	English acceptable
Clinical evidence	CER aligned with PMDA guidance	CER aligned with EU MDR MEDDEV 2.7/1
Standards	JIS standards often required alongside ISO	ISO/EN standards
Biocompatibility	ISO 10993 + PMDA-specific guidance	ISO 10993
Software	PMDA software guidance applies	EU MDR Annex I + MDCG guidance
Labeling	Japanese labeling requirements	EU labeling requirements

Key Sections of a Japan STED

1. Device Description and Specification

A comprehensive description of the device, including:

• Intended purpose and indications for use
• Device design and principle of operation
• Materials and components
• Accessories and combinations
• Variants and configurations

Japan-specific note: The intended purpose must be described in terms that align with the Japanese approval classification and any applicable certification standards.

2. Essential Principles Checklist (基本要件チェックリスト)

A systematic checklist demonstrating conformity with each applicable Essential Principle, citing:

• Applicable standards (JIS, ISO, IEC)
• Test reports
• Other evidence (literature, risk analysis)

This section is unique to Japan and is scrutinized carefully by PMDA reviewers.

3. Design and Manufacturing Information

• Design history and development rationale
• Manufacturing process description
• Quality control procedures
• Sterilization validation (if applicable)

4. Risk Management

Risk management documentation per ISO 14971, including:

• Hazard identification
• Risk estimation and evaluation
• Risk control measures
• Residual risk assessment
• Benefit-risk analysis

5. Non-Clinical Performance Studies

Test reports demonstrating device performance, including:

• Mechanical testing
• Electrical safety (IEC 60601 series, if applicable)
• Biocompatibility (ISO 10993)
• Sterility and shelf-life validation
• Software validation (IEC 62304, if applicable)

6. Clinical Evidence (CER)

The Clinical Evaluation Report — the most critical section for many devices. See our CER preparation guide for details.

7. Labeling

Draft Japanese labeling, including:

• Device name and model number
• Manufacturer information
• Intended use
• Instructions for use (IFU) in Japanese
• Contraindications, warnings, precautions

Common STED Preparation Mistakes

1. Directly translating EU STED without adaptation EU STEDs are not directly usable for Japan submissions. PMDA has specific requirements for document structure, referenced standards, and clinical evidence that differ from EU MDR.

2. Missing JIS standards PMDA expects conformity with applicable JIS (Japanese Industrial Standards) in addition to international ISO/IEC standards. Failing to address JIS standards is a common AIR trigger.

3. Inadequate Essential Principles Checklist The checklist must be comprehensive and cite specific evidence for each applicable principle. A generic or incomplete checklist will generate AIRs.

4. Weak benefit-risk analysis PMDA expects a clear, quantitative benefit-risk analysis — not a qualitative statement that "benefits outweigh risks."

How MK Consulting Can Help

At MK Consulting, STED preparation is a core part of our regulatory service. We have prepared STED documents for numerous GI endoscopy devices and other medical devices, and we understand exactly what PMDA reviewers expect.

Our STED preparation service includes:

• Gap analysis of your existing technical documentation
• Essential Principles Checklist preparation
• Identification of applicable JIS and ISO standards
• Integration of CER into the STED framework
• Japanese translation and localization

Contact us for a free STED consultation →