Essential Requirements and Essential Principles for Medical Devices

Understanding Approval Standards for Medical Devices

An “approval standard” refers to a standard for medical devices by which approval review is conducted through verification of conformity with that standard.

Approval standards are, in principle, composed of international standards and are established for products that do not require the submission of clinical trial data. The conformity with approval standards is assessed through a structured framework that includes multiple key elements.

Key Components of Approval Standards

Approval standards incorporate five essential elements. The scope of application specifies the target medical device using its general name. The technical standards establish requirements regarding performance, functions, and efficacy. The intended use, benefits, or effects section limits the scope of intended use covered by the standard. Conformity with essential requirements describes how the medical device must comply with fundamental requirements. The “other matters” section provides that devices whose structure, method of use, performance, and other characteristics differ markedly from existing medical devices shall be considered non-conforming with the standard.

The fourth element—”conformity with essential requirements”—is the primary focus of this discussion. It is important to note that conformity with essential requirements is similarly required for medical devices subject to certification standards.

Definition and Significance of Essential Requirements

Essential requirements are the fundamental standards specifying the quality, efficacy, and safety that all medical devices and in vitro diagnostic devices must possess. When submitting applications for manufacturing and marketing approval, certification, or notification of manufacturing and marketing for medical devices, applicants must submit materials demonstrating conformity with the essential requirements.

Japan’s essential requirements are established under the following legal instruments. For medical devices, the “Standards for Medical Devices as Determined by the Minister of Health, Labour and Welfare under Article 41, Paragraph 3 of the Pharmaceutical Affairs Law” (Ministry of Health, Labour and Welfare Ordinance No. 122 of 2005) applies. For in vitro diagnostic devices, the “Standards for In Vitro Diagnostic Devices as Determined by the Minister of Health, Labour and Welfare under Article 41, Paragraph 3 of the Pharmaceutical Affairs Law” (Ministry of Health, Labour and Welfare Ordinance No. 126 of 2005) governs.

International Regulatory Harmonization: Background and Evolution

The essential requirements for medical devices are grounded in international regulatory harmonization efforts. In 2005, the GHTF (Global Harmonization Task Force) established fundamental requirements defined as “common requirements regarding matters necessary in design and manufacture, primarily to ensure safety, when considering the use of any medical device or in vitro diagnostic device” (GHTF/SG1/N41R9:2005).

These foundational essential requirements were revised in 2012 and published as a final document (GHTF/SG1/N68:2012). Subsequently, in 2018, they were 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), representing further evolution of international standards.

In Japan, reflecting international harmonization principles, the “Essential Requirements” (Ministry of Health, Labour and Welfare Ordinance No. 122 of 2005) were established in 2005. Following subsequent amendments to the Pharmaceutical Affairs Law, the essential requirements were revised in August 2021. Accompanying this revision, the “Checklist for Conformity with Essential Requirements for Medical Devices” was also updated.

Structure of the Essential Requirements

The essential requirements are organized into two chapters: “Chapter 1: General Requirements” and “Chapter 2: Design and Manufacturing Requirements.”

Chapter 1 on general requirements encompasses fundamental requirements related to quality management systems and risk analysis and management. Chapter 2 on design and manufacturing requirements specifies detailed requirements for ensuring design quality, managing manufacturing processes, and maintaining product performance and safety.

Clarification of Cybersecurity Requirements

Currently, cybersecurity is interpreted as being encompassed within “risk management” under Article 2 of the essential requirements. However, regulatory authorities and industry stakeholders recognize the clarification of this requirement as an important regulatory priority.

Following the 2021 amendment, further strengthening of the essential requirements has been under consideration, and clarification of cybersecurity requirements is advancing. The direction of this revision indicates that the principle “throughout the entire product lifecycle, devices must be designed and manufactured to demonstrate system reproducibility, reliability, and performance” is planned to be incorporated into the essential requirements. This reflects the need to address the advancing digitalization and IoT implementation of medical devices, as well as the growing imperative to respond to cyber threats.

Role of the Essential Requirements Conformity Checklist

A conformity checklist for essential requirements is provided in “Guidance on the Checklist for Conformity with Essential Requirements for Medical Devices” (Pharmaceutical and Medical Devices Agency Notification No. 0818 First Issue).

When submitting applications for medical devices, applicants must add a column for “applicable company document numbers, etc.” to this checklist and identify materials documenting how each essential requirement is met. For detailed guidance, refer to “Examples of Entries in Documents Attached to Applications for Manufacturing and Marketing Certification of Medical Device Software.”

Verification of Essential Requirements Conformity for Certified Devices

For certified devices, checklists for verifying conformity with essential requirements are individually established by device classification. The content described in “applicability/non-applicability to the device,” “method of conformity,” and “verification of specific documents” may be modified if there is scientific justification.

However, should there be any change regarding “applicability/non-applicability to the device,” there exists a risk of deviating from the device’s “intended use or effect” or the “definition of general name.” Consequently, prior consultation with the designated certification body is required. This confirmation process is an essential step for maintaining appropriate device classification and regulatory consistency.