What Are the Essential Principles for Medical Devices (Japan)?

The Essential Principles for Medical Devices (医療機器基本要件基準) are critical regulatory standards for ensuring the safety and efficacy of medical devices. These standards define the fundamental requirements for manufacturing and selling medical devices in Japan, and manufacturers and marketing authorization holders must demonstrate compliance with these principles.

Legal Basis and Purpose

The Essential Principles for Medical Devices are standards established by the Minister of Health, Labour and Welfare based on Article 41, Paragraph 3 of the PMD Act (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices). The official name is “Standards for Medical Devices as Specified by the Minister of Health, Labour and Welfare pursuant to Article 41, Paragraph 3 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” (Ministry of Health, Labour and Welfare Notification No. 122 of 2005). The main purpose of these standards is to ensure the proper characteristics, quality, and performance of medical devices.

Background of International Harmonization

Japan’s Essential Principles were established in the context of international harmonization of medical device regulations. In 2005, the GHTF (Global Harmonization Task Force) established the “Essential Principles”—common requirements related to design and manufacturing primarily to ensure safety when the use of any medical device or in vitro diagnostic is assumed. These international Essential Principles were revised in 2012 and subsequently replaced by the IMDRF (International Medical Device Regulators Forum) document “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices” (IMDRF/GRRP WG/N47 FINAL:2018). Japan’s Essential Principles have been continuously revised in line with these international developments.

Similarly, the EU (European Union) has established comparable requirements called General Safety and Performance Requirements (GSPR) in Annex I of the EU MDR (Medical Device Regulation, Regulation (EU) 2017/745), creating an internationally harmonized regulatory framework.

Scope of Application

These standards apply to all medical devices. Specifically, when submitting applications for marketing authorization approval, certification applications, or notifications for medical devices, compliance with these standards must be demonstrated. Regardless of the class classification (general medical devices, controlled medical devices, or specially controlled medical devices), all medical devices must comply with the Essential Principles.

Structure of the Standards

The Essential Principles for Medical Devices consist of the following two chapters:

Chapter 1: General Requirements (Articles 1–6)

Chapter 1 establishes mandatory requirements that apply to all medical devices.

Article	Content
Article 1	Design: Medical devices shall be designed and manufactured so as not to compromise patient safety or health when used under conditions and for purposes intended by the manufacturer
Article 2	Risk Management: Risk analysis, evaluation, and control shall be implemented, and residual risks shall not outweigh benefits
Article 3	Performance and Functions: Medical devices shall be able to demonstrate their intended performance and functions
Article 4	Shelf Life or Service Life: Consideration shall be given to performance degradation over time
Article 5	Transport and Storage: Characteristics and performance shall be maintained under transport and storage conditions
Article 6	Efficacy: Evaluation that benefits outweigh risks

Chapter 2: Design and Manufacturing Requirements (Articles 7–17)

Chapter 2 establishes requirements that apply selectively according to the characteristics of the medical device. These apply only to relevant medical devices.

Article	Content
Article 7	Chemical Characteristics: Consideration of material biocompatibility, toxicity, etc.
Article 8	Prevention of Microbial Contamination: Sterilization, reduction of microbial contamination risks
Article 9	Consideration for Use Environment: Electromagnetic interference, resistance to environmental conditions
Article 10	Consideration for Measurement or Diagnostic Functions: Ensuring measurement accuracy and stability
Article 11	Protection Against Radiation: Safety assurance for devices that emit radiation
Article 12	Consideration for Medical Devices Using Programs: Software reliability, cybersecurity
Article 13	Consideration for Active Medical Devices and Devices Connected Thereto
Article 14	Consideration for Mechanical Hazards
Article 15	Consideration for Medical Devices That Supply Energy or Substances
Article 16	Consideration for Medical Devices Intended for Use by General Users
Article 17	Information Provision to Users Through Publication of Precautionary Information or Package Inserts

Key Requirements

The Essential Principles include the following important requirements:

Ensuring Safety in Design and Manufacturing: Medical devices must be designed and manufactured so as not to compromise the clinical condition and safety of patients, or the safety and health of users and third parties, when used under conditions and for purposes intended by the manufacturer.

Risk Management: Implementation of a risk management process based on ISO 14971 is required. All known or foreseeable hazards must be identified, risks must be evaluated, and risks must be reduced as far as reasonably practicable.

Ensuring Medical Device Performance and Functions: It is necessary to verify and validate that medical devices can demonstrate their specified performance and functions in light of their intended use.

Consideration for Chemical Characteristics and Biocompatibility: Design that considers the interaction between materials comprising medical devices and the human body (toxicity, allergic reactions, etc.) is required. Biological safety evaluation based on the ISO 10993 series plays an important role.

Prevention of Microbial Contamination: For sterile medical devices, appropriate sterilization validation (ISO 11135, ISO 11137, etc.) must be performed to ensure sterility.

Accuracy and Stability of Devices with Measurement/Diagnostic Functions: For medical devices with measurement or diagnostic functions, it is necessary to ensure and verify measurement accuracy, reproducibility, and stability.

Cybersecurity Requirements (2023 Revision)

On March 9, 2023, the Essential Principles were revised, and cybersecurity requirements were newly established as Article 12, Paragraph 3. This revision became applicable from April 1, 2023, and after a one-year transition period, became fully applicable from April 1, 2024.

Article 12, Paragraph 3 stipulates the following:

For medical devices using programs that are used in connection with other devices and networks or for which unauthorized access and attack access from external sources are anticipated, appropriate requirements shall be identified based on the operating environment and network usage environment of the medical device, and cybersecurity risks that may impair the function of the medical device or cause safety concerns shall be identified and evaluated, and management to reduce such risks shall be implemented. Additionally, such medical devices shall be designed and manufactured based on a plan to ensure cybersecurity throughout the entire lifecycle of the medical device.

This revision is based on the IMDRF N60 document “Principles and Practices for Medical Device Cybersecurity” and incorporates the following three perspectives:

1. Having a plan to ensure medical device cybersecurity throughout the entire product lifecycle
2. Conducting design and manufacturing that reduces cyber risks
3. Setting minimum requirements for hardware, network, and IT security measures necessary for appropriate operating environments

How to Confirm Compliance

Compliance with Article 12, Paragraph 3 of the Essential Principles can be confirmed through compliance with JIS T 81001-5-1 (Health software and health IT systems safety, effectiveness and security—Part 5-1: Security—Activities in the product life cycle). Marketing authorization holders are required to implement cybersecurity assurance activities based on their Quality Management System (QMS) and appropriately record and maintain the results.

Confirmation of Compliance

Marketing authorization holders use the “Essential Principles Compliance Checklist for Medical Devices” to confirm compliance with the Essential Principles. This checklist is notified by the Ministry of Health, Labour and Welfare and is used as a tool to systematically confirm compliance with each requirement.

In the checklist, the following must be documented for each article:

• Compliance status (compliant, non-compliant, not applicable)
• Identification of documents or test reports that demonstrate compliance
• Reasons for non-applicability when applicable

When submitting applications for marketing authorization approval, certification applications, or notifications, materials related to Essential Principles compliance, including this checklist, must be submitted.

Related International Standards

The following international standards are widely referenced to demonstrate compliance with the Essential Principles:

Standard Number	Content
ISO 14971	Medical devices—Application of risk management to medical devices
ISO 13485	Medical devices—Quality management systems
IEC 62366-1	Medical devices—Application of usability engineering
IEC 62304	Medical device software—Software life cycle processes
ISO 10993 series	Biological evaluation of medical devices
JIS T 81001-5-1	Health software security

Summary

The Essential Principles for Medical Devices are an important regulatory framework for ensuring the quality, efficacy, and safety of medical devices, and marketing authorization holders are required to bring products that comply with these standards to market. As exemplified by the addition of cybersecurity requirements in 2023, the standards are continuously revised in response to technological advances and international regulatory trends, and it is important for marketing authorization holders to understand the latest requirements and respond appropriately.

Furthermore, Japan’s Essential Principles are harmonized with international standards such as IMDRF guidance, and can be utilized as a foundation for responding to international regulatory requirements for companies engaged in global medical device development and sales.