MSC Regulatory Watch — Medical Device Software Regulatory Knowledge Database

MSC Regulatory Watch

Medical Device Software — Regulatory & Standards Knowledge Base

LIVE — Last crawled: 2026-06-24 17:27 JST

Vol.1 — June 24, 2026

MSC Portal ›Regulatory Watch› All Entries (124)

Standards, Guidance & Notices

Showing 121–124 of 124

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EU
MDCG

MDCG 2024-5 Appendix A

MDCG 2024-5 Appendix A

PUBLISHED NEW SaMD Classification

EU
MDCG

MDCG 2024-3 Appendix A

MDCG 2024-3 Appendix A

PUBLISHED NEW SaMD Classification

EU
MDCG

MDCG 2024-4 Appendix

MDCG 2024-4 Appendix

PUBLISHED NEW SaMD Classification

EU
MDCG

MDCG 2021-5 rev.1

MDCG 2021-5 rev.1 - Appendix

PUBLISHED NEW SaMD Classification

‹ 1 … 11 12 13

Database Stats

170

Total Entries

9

Last 90 Days

12

Bodies

13

Pages

New — Last 30 Days

【総務省電波利用ポータル】令和7年度「電波の医療機器等への影響に関する調査」報告書公開について

JAAME — 委員会情報公開

FDA Updates Lists of Medical Devices that Incorporate Digital Health Technology

Artificial Intelligence Enabled Medical Devices

IMDRF Primer: Understanding the International Foundation of SaMD Regulation

Final guidance for human factors

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Operated by MSC (Medical Software Consulting). Automated weekly & monthly crawling of FDA, NIST, MHLW, JFMDA, EU MDCG, CEN/CENELEC, and IMDRF public documents. IEC/ISO standard metadata is manually curated.

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