Amendment to the Medical Device Basic Requirements Standard

Background and Overview of the Amendment

With the enactment of amendments to the Pharmaceutical Affairs Law (Yakuhin-ho) in August 2021 (Reiwa 3), the Medical Device Basic Requirements Standard was revised. To address all aspects of this amendment, the Ministry of Health, Labour and Welfare simultaneously revised the “Checklist for Conformity with Basic Requirements for Medical Devices,” creating an enabling environment for smooth compliance with the new standards.

For medical devices subject to approval or licensing applications on or after August 1, 2021 (Reiwa 3), compliance with the amended Medical Device Basic Requirements Standard is mandatory. Addressing this amendment is a critical factor directly linked to the market entry timeline for medical devices, requiring careful consideration from the early stages of application preparation.

Principal Amendments to the Basic Requirements Standard

The primary amendments to the Basic Requirements Standard concern two provisions related to information provision to users.

Article 9, Paragraph 2 (Consideration of Usage Environment)

This provision clarifies the information disclosure requirements regarding appropriate consideration of the environment in which medical devices are used. Specifically, manufacturers are now required to provide more comprehensive information about the anticipated conditions of the usage environment, usage restrictions, and appropriate usage methods for medical devices.

Article 11 (Publication of Cautions and Other Information or Inclusion in Package Inserts for Information Provision to Users)

This provision addresses amendments regarding the methods of providing important safety information, cautions, and warning information to medical device users and other relevant parties. This amendment reflects the diversification of information provision methods in the digital age and aims to improve user access to information about medical devices.

Significant Changes in Information Provision Methods

Regulatory requirements until now limited medical device information provision to “package inserts and related materials” (fukusoku bunsho to). This term referred to documents directly attached to medical devices or information recorded on their containers or packaging. This approach reflected regulatory frameworks designed for traditional distribution systems that assumed physical document delivery.

However, the recent amendment to the Pharmaceutical Affairs Law has expanded information provision methods. Under the new requirements, manufacturers may now publish caution information and other safety-related information on websites and other digital platforms, with the package insert containing a link or reference to such published information. This change enables the rapid provision of up-to-date safety information and ensures that users have continuous access to current information. This represents an important amendment accommodating both advances in digital technology and the diversification of global medical device distribution channels.

In the context of international regulatory harmonization, this amendment aligns with the regulatory directions of the EU MDR and the positions of the ICMRA (International Coalition of Medicines Regulatory Authorities), reflecting a global trend toward modernized information provision practices.

Revision of the Conformity Checklist

Accompanying the amendment, the “Checklist for Conformity with Basic Requirements for Medical Devices” has been revised. This checklist serves as a systematic tool for medical device manufacturers to verify their compliance with the amended basic requirements when preparing application documents. Manufacturers are encouraged to use this checklist to conduct detailed verification of how their medical devices comply with the amended basic requirements and to revise application documents as needed.

Conclusion

The amendment to the Medical Device Basic Requirements Standard represents an important revision aimed at both strengthening the assurance of safety and effectiveness of medical devices and modernizing information provision methods. For medical device manufacturers and importers planning to file applications after the implementation date of August 1, 2021 (Reiwa 3), it is essential to fully understand the amended requirements and begin implementation preparations promptly.

Related Notifications

For detailed information on the amendments, please refer to the following official notifications from the Ministry of Health, Labour and Welfare:

1. “Partial Amendment to the Medical Device Standards as Stipulated 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. 267, dated July 2, 2021 [Reiwa 3])
2. “Regarding the Checklist for Conformity with Basic Requirements for Medical Devices” (Notification PFSB/DID No. 0818-1, dated August 20, 2021 [Reiwa 3])