Standards, Guidance & Notices
Showing 21–30 of 40
JFMDA
Notice
Notice
jaame-committee
COVID-19 Prevention Guideline for Medical Device Sales, Rental, and Repair Business Operations
JAAME Sales and Maintenance Committee guideline (May 8, 2023) providing infection prevention measures and operational protocols for medical device distribution and service sectors during pandemic conditions.
Published: 2023-03-15
EU
MDCG
MDCG
MDCG 2022-19
Performance study application/notification documents under Regulation (EU) 2017/746
MDCG 2022-19 — Performance study application/notification documents under Regulation (EU) 2017/746 — (December 2022)
Published: 2022-12-01
JFMDA
Notice
Notice
jaame-well-known-matters-1
Clinical Evaluation Report Documentation Examples (1) and (2)
JAAME Clinical Evaluation Committee documentation examples (November 1, 2022) illustrating proper clinical evaluation report formatting and content based on the 2020 guidance on clinical evaluation report and consultation material preparation.
Published: 2022-11-01
EU
MDCG
MDCG
MDCG 2020-10
Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form
MDCG 2020-10 — Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form — (October 2022 October 2022)
Published: 2022-10-01
EU
MDCG
MDCG
MDCG 2022-15
Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
MDCG 2022-15 — Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD — (September 2022)
Published: 2022-09-01
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
Inquiry Contact Desk Establishment for GS1-128 Barcode Reading Application for Medical Devices
JAAME PMS Committee announcement (June 1, 2022) establishing inquiry procedures and publishing frequently asked questions regarding GS1-128 barcode reading applications for medical device identification and traceability purposes.
Published: 2022-06-01
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
METI Healthcare International Development Website Release
Announcement of METI Healthcare Industry Division's new web portal providing consolidated information on past support programs, research reports, and government agency consultation services for healthcare industry internationalization.
Published: 2022-03-25
JFMDA
Notice
Notice
jaame_20220314_承認審査講習会R3
Fiscal 2021 Collaborative Plan for Medical Device Regulation and Review Optimization: Marketing Approval Review Training Program
Video viewing platform for PMDA collaborative plan training program (FY2021) covering marketing approval review procedures, regulatory requirements, and best practices for medical device manufacturers and regulatory professionals.
Published: 2022-03-14