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.
| Date | Title | Original in Japanese |
|---|---|---|
| FY2022 | ||
| 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 |
Implementation of Information Provision on Proper use of Automated External Defibrillators and Defibrillator Electrodes for Body Surface English [85.0 KB] | Japanese [123 KB] |
| FY2021 | ||
| 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 | ||
| 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 | ||
| 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] |