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 25, 2026

MSC Portal ›Regulatory Watch› All Entries (30)

Standards, Guidance & Notices

Showing 1–10 of 30

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JFMDA
Notice

jaame_20260617_総務省電波利用ポータル令和7年度電波のMedDev等への影響に関

【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

PUBLISHED NEW SaMD Classification

Published: 2026-06-17

JFMDA
Notice

jaame-committee-btoc_report

一般消費者向け医療機器等研究会報告書

PUBLISHED NEW SaMD Classification

Published: 2026-03-23

JFMDA
Notice

committee-Startup_Report

医療機器産業イノベーション戦略 2.0 －スタートアップ共創による産業構造転換－

PUBLISHED NEW SaMD Classification

Published: 2026-03-17

JFMDA
Notice

jaame-committee-ai

AI活用プログラム医療機器における審査に関する検討 ―研究結果の報告― 英訳版

PUBLISHED NEW AI / Machine Learning

Published: 2026-01-22

JFMDA
Notice

committee-fuguai

医療機器不具合用語集の活用について

PUBLISHED NEW SaMD Classification

Published: 2026-01-09

JFMDA
Notice

jaame-committee-windows-2

Windows セキュアブート証明書の有効期限に関する注意喚起

PUBLISHED NEW Cybersecurity

Published: 2025-09-29

JFMDA
Notice

committee-AI

AI活用プログラム医療機器における審査に関する検討 ―研究結果の報告―

PUBLISHED NEW AI / Machine Learning

Published: 2025-08-27

JFMDA
Notice

committee-AI_Guidance_1.0

仮名加工情報の利活用によるAI 医療機器の開発のための企業向けガイダンス第1.0版

PUBLISHED NEW AI / Machine Learning

Published: 2024-12-26

JFMDA
Notice

jaame-well-known-matters-samd

SaMD 版リバランス通知(二段階承認)に基づく想定事例集（疾病診断用プログラム医療機器）

PUBLISHED NEW AI / Machine Learning

Published: 2024-09-24

JFMDA
Notice

well-known-matters-chiken-anketo+report2024

医療機器治験の実施状況アンケート結果報告

PUBLISHED NEW SaMD Classification

Published: 2024-09-04

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Database Stats

170

Total Entries

8

Last 90 Days

12

Bodies

3

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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