Standards, Guidance & Notices
Showing 11–20 of 40
EU
MDCG
MDCG
MDCG 2021-25 rev.1
Application of MDR requirements to " legacy devices " and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
MDCG 2021-25 rev.1 — Application of MDR requirements to " legacy devices " and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC — (October 2024)
Published: 2024-10-01
JFMDA
Notice
Notice
well-known-matters-chiken-anketo+report2024
Medical Device Clinical Trial Implementation Status Survey Results Report
September 4, 2024 survey report on medical device clinical trial implementation status in Japan, addressing historical challenges regarding high costs, delayed subject enrollment, and data quality concerns in the Japanese clinical trial environment.
Published: 2024-09-04
EU
MDCG
MDCG
MDCG 2021-4 rev.1
Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
MDCG 2021-4 rev.1 — Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 — (September 2024)
Published: 2024-09-01
JFMDA
Notice
Notice
jaame-committee-40
JFMDA 40th Anniversary Commemorative Project Dedicated Website
Website featuring JFMDA's 40th anniversary commemorative initiatives launched in February 2024, including digest videos and resources celebrating the organization's four decades of contribution to the medical device industry.
Published: 2024-05-07
EU
MDCG
MDCG
MDCG 2024-5
Guidance on the Investigator’s Brochure content Appendix A of the MDCG 2024-5
MDCG 2024-5 — Guidance on the Investigator’s Brochure content Appendix A of the MDCG 2024-5 — (April2024 April2024)
Published: 2024-04-01
EU
MDCG
MDCG
MDCG 2024-4
Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 Appendix – Performance Study Summary Safety Reporting Form
MDCG 2024-4 — Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 Appendix – Performance Study Summary Safety Reporting Form — (April 2024)
Published: 2024-04-01
JFMDA
Notice
Notice
committee-emc
Public Release of METI's Representative Examples of Radio Waves from Mobile Phones and Radio Utilization Equipment
JAAME Technical Committee EMC Subcommittee notice (November 2023) regarding METI's published examples of radiofrequency emissions from mobile telecommunications devices, relevant to electromagnetic compatibility assessment of medical devices.
Published: 2023-11-16
MHLW
Notice
Notice
Admin-Notice-2023-05-29
Publication of Guidance on Appropriate and Expedited Approval and Development of Software as Medical Devices (SaMD)
Practical guidance on expedited regulatory approval for SaMD including two-stage approval processes. Clarifies early marketing approval application handling across different development stages while maintaining consistent pre- and post-market safety/effectiveness assurance. Developed through public-private-academic collaboration as part of DASH for SaMD strategy, applicable to AI/ML-enabled SaMD.
Published: 2023-05-29
JFMDA
Notice
Notice
jaame_20230502_臨床評価手引き
Clinical Evaluation Report and Clinical Evaluation Consultation Material Preparation Guidance Part 1 & Part 2
JAAME Clinical Evaluation Committee guidance documents (May 2, 2023) providing comprehensive instructions for preparing clinical evaluation reports and consultation materials, including acceptance criteria and fundamental requirements for regulatory submissions.
Published: 2023-05-02
MHLW
Notice
Notice
MHLW-PSEHB-MDED-0331-No.1
Partial Amendment of Guideline on Software as a Medical Device Classification
Revision of 2021 SaMD classification guideline (2023 version). Clarifies and refines classification criteria based on accumulated consultation cases. Adds judgment criteria for AI/ML-enabled software, cloud-based programs, and wellness applications. Maintains alignment with IMDRF N10 and N12. Updates judgment flow based on intended use and risk.
Published: 2023-03-31