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 (30)

Standards, Guidance & Notices

Showing 21–30 of 30

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JFMDA
Notice

jaame_20220314_承認審査講習会R3

令和３年度医療機器規制と審査の最適化のための協働計画における承認審査等に関する講習会

PUBLISHED NEW SaMD Classification

Published: 2022-03-14

JFMDA
Notice

jaame-well-known-matters-2

医療機器治験における被験者の健康被害補償に関する考え方

PUBLISHED NEW SaMD Classification

Published: 2021-10-18

JFMDA
Notice

jaame_20210706_化学分析生物学的安全性

化学分析と生物学的安全性評価に関する解説 PMDA穴原様

PUBLISHED NEW SaMD Classification

Published: 2021-07-06

JFMDA
Notice

jaame_20210510_非邦文試験成績書受入

邦文以外で作成された試験成績書等の受入れについて

PUBLISHED NEW SaMD Classification

Published: 2021-05-10

JFMDA
Notice

jaame-well-known-matters-ikw

PMDAの「IKWサイト」及び添付文書の届出・掲載方法について

PUBLISHED NEW SaMD Classification

Published: 2021-02-13

JFMDA
Notice

well-known-matters-tebiki

添付文書の手引書の活用について

PUBLISHED NEW SaMD Classification

Published: 2018-10-31

JFMDA
Notice

jaame_20181031_トレーサビリティ推進協議会

「医療製品識別とトレーサビリティ推進協議会」

PUBLISHED NEW SaMD Classification

Published: 2018-10-31

JFMDA
Notice

jaame_20181031_承認申請Guidance

質の高い製造販売承認申請のためのガイダンス

PUBLISHED NEW SaMD Classification

Published: 2018-10-31

JFMDA
Notice

jaame_20181031_臨床研究法

臨床研究法について

PUBLISHED NEW SaMD Classification

Published: 2018-10-31

JFMDA
Notice

well-known-matters-yakuji_statistics_guideline

薬事工業生産動態統計調査票記入ガイドライン

PUBLISHED NEW SaMD Classification

Published: 2018-10-31

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Database Stats

170

Total Entries

9

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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