Standards, Guidance & Notices
Showing 81–90 of 124
EU
MDCG
MDCG
MDCG 2022-14
Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs
MDCG 2022-14 — Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs — (August 2022)
Published: 2022-08-01
EU
MDCG
MDCG
MDCG 2022-12
Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)
MDCG 2022-12 — Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) — (July 2022)
Published: 2022-07-01
JFMDA
Notice
Notice
jaame-well-known-matters-gs1-128
医療機器のGS1-128読取アプリに関する問い合わせ窓口設置について
Published: 2022-06-01
IMDRF
IMDRF/AIMD WG/N67 (Edition 1)
Machine Learning-enabled Medical Devices: Key Terms and Definitions
Published: 2022-05-09
EU
MDCG
MDCG
MDCG 2022-8
Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
MDCG 2022-8 — Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC — (May 2022)
Published: 2022-05-01
JFMDA
Notice
Notice
jaame_20220325_経産省ヘルスケア国際展開
経済産業省「ヘルスケア国際展開ウェブサイト」リリース
Published: 2022-03-25
JFMDA
Notice
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: 2022-03-14
JFMDA
Notice
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: 2021-10-18
JFMDA
Notice
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: 2021-07-06
EU
MDCG
MDCG
MDCG 2021-13 rev.1
Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
MDCG 2021-13 rev.1 — Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR — (July 2021)
Published: 2021-07-01