Notifications Related to Safety Measures (medical devices)

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The following notifications and administrative notices issued by the Ministry of Health, Labor and Welfare (MHLW) or the PMDA were selected for translation among those related to safety measures for medical devices in consideration of priority for translation.

**FY2023**
Date/ Notification No.	Title	Original in Japanese
March 28, 2024 PSB/MDED 0328 No.1 PSB/PSD 0328 No.3	Management of Vulnerabilities to Ensure Cybersecurity of Medical Devices English [54.0 KB]	Japanese [136 KB]
January 15, 2024 PSB/PSD 0115 No.2	Basic Principles for Adverse Events Reporting Regarding Cybersecurity of Medical Devices English [102 KB]	Japanese [338 KB]
May 23, 2023 PSEHB/MDED 0523 No.1	Confirmation of compliance with Article 12, Paragraph 3 of the Essential Principles for Medical Devices English [43.9 KB]	Japanese [456 KB]

**FY2022**
Date/ Notification No.	Title	Original in Japanese
February 17, 2023 PMDA/CSO No.60	Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. English [252 KB]	Japanese [1,024 KB]
September 20, 2022 Administrative Notice	Questions and Answers (Q&A) on MR Safety of Implantable Medical Devices, etc. (Part 2) English [84.6 KB]	Japanese [333 KB]
September 13, 2022 HPB/DPMM 0913 No.2 PSEHB/PSD 0913 No.2	Labeling of Codes on Containers to Identify Medical Devices, In Vitro Diagnostics, etc. English [133 KB]	Japanese [273 KB]
May 26, 2022 PSEHB/MDED0526 No.1 PSEHB/PSD0526 No.1	Points to Consider for Consultations Associated with Revision of Descriptions in Package Inserts, etc. of Medical Devices English [58.7 KB]	Japanese [123 KB]

**FY2021**
Date/ Notification No.	Title	Original in Japanese
February 18, 2022 PSEHB/PSD0218 No.1	Occurrence of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in Patients Implanted with a Gel-filled Breast Implant or Tissue Expander, and Information Provision to the Patients (Request for Information Dissemination) English [35.2 KB]	Japanese [462 KB]
November 12, 2021 Administrative Notice	Publication of the Medical Device Adverse Event Terminology Based on the IMDRF Adverse Event Terminology English [65.4 KB]	Japanese [8.6 MB]
July 30, 2021 PSEHB/PSD0730 No.4	Occurrence of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in Patients Implanted with a Gel-filled Breast Implant or Tissue Expander, and Information Provision to the Patients (Request for Information Dissemination) English [112 KB]	Japanese [357 KB]
May 14, 2021 Administrative Notice	Points to Consider for Consultations Associated with Revision of Descriptions in Package Inserts, etc. of Medical Devices English [58.7 KB]	Japanese [187 KB]

**FY2020**
Date/ Notification No.	Title	Original in Japanese
October 7, 2020 PSEHB/MDED 1007 No.1 PSEHB/PSD 1007 No.1	Information Documents for Patients with Gel-filled Breast Implants, Tissue Expanders, etc. English [113 KB]	Japanese [11.9 KB]
April 15, 2020 PSEHB/PED Notification 0415 No.1 PSEHB/MDED Notification 0415 No.1 PSEHB/PSD Notification 0415 No.2	Post-marketing Safety Measures for Drug-eluting Coronary Stents, etc. English [160 KB]	Japanese [140 KB]

**FY2019**
Date/ Notification No.	Title	Original in Japanese
November 15, 2019 Administrative Notice	Questions and Answers (Q&A) on MR Safety of Implantable Medical Devices, etc. English [157 KB]	Japanese [1,156 KB]

**FY2017**
Date/ Notification No.	Title	Original in Japanese
December 27, 2017 HPB/GAD Notification No. 1227-1 PSEHB/PED Notification No. 1227-1 PSEHB/MDED Notification No. 1227-1 PSEHB/PSD Notification No. 1227-1	Switching of Small-bore Connectors for Neuraxial Anesthesia English [338 KB]	Japanese [646 KB]
October 4, 2017 HPB/GAD Notification No. 1004-1 PSEHB/PED Notification No. 1004-1 PSEHB/MDED Notification No. 1004-1 PSEHB/PSD Notification No. 1004-1	Introduction of the International Standards (ISO (IEC) 80369 series) Related to Connectors for Prevention of Interconnection English [237 KB]	Japanese [880 KB]

**FY2016**
Date/ Notification No.	Title	Original in Japanese
December 27, 2016 PSEHB/ELD/OMDE Notification No. 1227-1 PSEHB/SD Notification No. 1227-1	Handling of Powdered Medical Gloves English [31 KB]	Japanese [40.7 KB]

**FY2014**
Date/ Notification No.	Title	Original in Japanese
October 24, 2014 PFSB/ELD Notification No. 1024-2 PFSB/ELD/OMDE Notification No. 1024-1 PFSB/SD Notification No. 1024-9 PFSB/CND Notification No.1024-15	Handling of Marketing Application for Combination Products English [109 KB]	Japanese [140 KB]