Notifications Related to Safety Measures (Medical Devices)

Notifications issued by the Ministry of Health, Labour and Welfare and other organizations regarding safety measures for medical devices are available here.
 

Date	Title	Original in Japanese (PDF or Link)
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.
July 29, 2022 PMDA/OIMS Notification No.0729001 PMDA/OPI Notification No.0729001 PMDA/OPII Notification No.0729001 PMDA/OMQVMD Notification No.0729001	Points to Consider, etc. for Consultation associated with Revision, etc. of Package Inserts, etc.
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
March 1, 2022 Administrative Notice	Strengthening Cyber Security Measures related to Medical Devices, etc. （Request）
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)
December 3, 2021 Administrative Notice	Publication of Educational Videos for Proper Use of Contact Lenses
November 12, 2021 Administrative Notice	Publication of the Medical Device Adverse Event Terminology Based on the IMDRF Adverse Event Terminology
August 23, 2021  Administrative Notice	Responding to Vulnerabilities in the Operating Systems of Medical Devices (Precautions)
August 3, 2021  HPB/GAD/MSPO0803 No.1  PSEHB/PSD0803 No.1	"Guidance for Safe and Secure Use of Radio Waves in Medical Institutions" by the Electromagnetic Compatibility Conference Japan (revised version) in July, 2021
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)
July 30, 2021 HRB/RMCPD0730 No.3 PSEHB/MDED0730 No.3 PSEHB/PSD0730 No.3	Ensuring the Provision of Information on Precautions to be Taken When Using an Automated External Defibrillator  without a Shock Button (Auto Shock AED)
May 14, 2021 Administrative Notice	Points to Consider for Consultations Associated with Revision of Descriptions in Package Inserts, etc. of Medical Devices
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.
July 27, 2020 HPB/GAD/MSPO 0727 No.1 PSEHB/PSD 0727 No.1	FY 2019 Report on the Investigation of the Impact of Radio Waves on Implantable Medical Devices and Medical Devices for Home Use etc. Compiled by the Ministry of Internal Affairs and Communications Appendix: Report on the Investigation of the Impact of Radio Waves on Implantable Medical Devices and Medical Devices for Home Use etc.
June 22, 2020 Administrative Notice	Publication of Education Video and Poster related to Proper Use of Contact Lenses
May 13, 2020 PSEHB/MDED 0513 No.1 PSEHB/PSD 0513 No.1	Publication of IMDRF Principles and Practices for Medical Device Cybersecurity (Request for circulation)
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.
January 28, 2020 PSEHB/PSD 0128 No.1	Proper Information Provision on MRI Testing in Patients with Metal-on-Metal Hip Joints (request for cooperation) Appendix: MRI Testing in Patients with Metal-on-Metal Hip Joints
November 22, 2019 HPB/GAD/MSPO 1122 No.1 PSEHB/PSD 1122 No.1	FY 2019 Report on Investigation of the Influence of Radio Wave Disruption on Implantable Medical Devices and Medical Devices for Home Use, etc. Compiled by the Ministry of Internal Affairs and Communications Appendix: Report on the Investigation of the Influence of Radio Wave Disruption on Implantable Medical Devices and Medical Devices for Home Use, etc.
November 15, 2019 Administrative Notice	Questions and Answers (Q&A) on MR Safety of Implantable Medical Devices, etc.
November 11, 2019 PSEHB/PSD 1111 No.2	Revision of Information Documents for Patients etc. with Gel-filled Breast Implants and Tissue Expanders (request for circulation) Appendix: To Patients Having Undergone Tissue Expander Surgery and Waiting for Breast Reconstruction with Breast Implants (gel-filled breast implants) To Patients Wishing to Have Breast Reconstruction with Breast Implants (gel-filled breast implants) To Patients Having Undergone Breast Reconstruction with Breast Implants (gel-filled breast implants) FAQs on Brest Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
November 11, 2019 Administrative Notice	Education to Elementary and Middle School Children for Proper Use of Contact Lenses: Publication of Educational Material
October 1, 2019 PSEHB/PSD1001 No.2	Ensuring the Provision of Information for Patients etc. with Gel-filled Breast Implants and Tissue Expanders (request for cooperation) Appendix: To Patients Having Undergone Tissue Expander Surgery and Waiting for Breast Reconstruction with Breast Implants (gel-filled breast implants) To Patients Wishing to Have Breast Reconstruction with Breast Implants (gel-filled breast implants) To Patients Having Undergone Breast Reconstruction with Breast Implants (gel-filled breast implants) FAQs on Brest Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Updated on November 11, 2019
August 1, 2019 PSEHB/MDED No.0801-1 PSEHB/PSD No.0801-4	Measures for MR Safety in Implantable Medical Devices, etc.
September 28, 2018 HPB/GAD/MSPO0928 No.1 PSEHB/PSD0928 No.1	FY 2018 Report on Investigation of the Influence of Radio Wave Disruption on Implantable Medical Devices and Medical Devices for Home Use, etc. Compiled by the Ministry of Internal Affairs and Communications Appendix: Report on the Investigation of the Influence of Radio Wave Disruption on Implantable Medical Devices and Medical Devices for Home Use, etc.
July 24, 2018 PSEHB/MDED0724 No.1 PSEHB/PSD0724 No.1	Guidance on Ensuring Cyber Security of Medical Devices
May 11, 2018 HPB/GAD/MSPO0511 No.1 PSEHB/PSD0511 No.1	Public Awareness Educational Materials Prepared by the Electromagnetic Compatibility Conference Japan concerning Safe and Secure Radio Wave Utilization in Medical Institutions
April 13, 2018 PSEHB0413 No.4	Notification on Self-inspections for Pharmaceuticals etc. Manufactured from Materials, etc. Derived from Species of the Finnish Cervidae Family
October 16, 2017 PSEHB/PSD1016 No.1	Concerning Efforts to Raise Awareness for the Prevention of Accidents involving Electric Massagers for Household Use (request for cooperation)
September 26, 2017 PSEHB0926 No.5	Dissemination of Information etc. related to Proper Use of Contact Lenses
September 21, 2017 PSEHB/SD0921 No.1	Reminder of Proper Handling of Single-use Medical Devices and Efforts to Raise Awareness of Safety Measures Regarding Medical Devices
September 1, 2017 PSEHB/MDED0901 No.1 PSEHB/SD0901 No.1	Proper Use of the "IMPELLA, a catheter-based ventricular assist device" Medical Device Product
August 8, 2017 PSEHB/MDED0808 No.1 PSEHB/SD0808 No.1	Proper Use of the "Lutonix Drug-Coated Balloon Catheter (For Femoropopliteal Artery)" Medical Device Product
July 12, 2017 HPB/GAD 0712 No.1 PSEHB/PSD0712 No.1	Regulations concerning Safe Radio Wave Utilization in Medical Institutions (Example) Prepared by the Electromagnetic Compatibility Conference Japan
June 20, 2017 PSEHB/MDED0620 No.3 PSEHB/SD0620 No.1	Proper Use of the "EDWARDS INTUITY Elite Valve System" Medical Device Product
January 10, 2017 PSEHB/MDED0110 No.4 PSEHB/SD0110 No.6	Proper Use of the "Long-pulse Alexandrite Laser GentleLase Pro" Medical Device Product
December 27, 2016 PSEHB/MDED1227 No.1 PSEHB/SD1227 No.1	Handling of Powdered Medical Gloves
November 25, 2016 Administrative Notice	Issuance of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices (Revised in November 2016) Compiled by the Ministry of Internal Affairs and Communications Reference: Revision and Results of Public Comments related to the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices	(Link)
November 22, 2016 PSEHB/MDED1122 No.7 PSEHB/SD1122 No.4	Proper Use of the "HeartFlow FFRCT" Medical Device Product
April 8, 2016 HPB/GAD0408 No.2 PSEHB/SD0408 No.1	Guidance concerning Safe and Secure Radio Wave Utilization in Medical Institutions Prepared by the Electromagnetic Compatibility Conference Japan
March 28, 2016 PSEHB/MDED0328 No.2 PSEHB/SD0328 No.10	Examinations Using Magnetic Resonance Imaging Diagnostic Equipment of Patients Undergoing Intraocular Metal Drain Placement
January 22, 2016 Administrative Notice	Efforts to Raise Awareness of the Proper Use of Electric Massagers for Household Use (information provision)
December 21, 2015 Administrative Notice	Precautions concerning Malfunction etc. Reports for Medical Device Programs, etc.
September 18, 2015 PFSB/ELD/OMDE/C0918 No.1 PFSB/SD0918 No.10	Proper Use of the "Cook Spectrum Central Venous Catheter Sets - Minocycline/Rifampin Impregnated" Medical Device Product
September 3, 2015 Administrative Notice	Issuance of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices (Revised in August 2015) Compiled by the Ministry of Internal Affairs and Communications Reference: Revision and Results of Public Comments related to the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices	(Link)
August 27, 2015 PFSB/SD0827 No.1	Reminder concerning Information related to the Handling, etc. of Single-use Medical Devices
August 10, 2015 Administrative Notice	Activities related to Promoting Awareness and Understanding of the Proper Use of Colored Contact Lenses
June 18, 2015 HPB/EAD0618No.10 PFSB/ELD/OMDE/C0618 No.1 PFSB/SD0618 No.1	Proper Use of the "EXCOR Pediatric Ventricular Assist Device" Medical Device Product
April 28, 2015 PFSB/ELD/OMDE/C0428 No.1 PFSB/SD0428 No.1	Ensuring Cyber Security of Medical Devices
April 17, 2015 HPB/EAD0417 No.1 PFSB/ELD/OMDE/C0417 No.1 PFSB/SD0417 No.1	Proper Use of the "Pipeline Flex flow diverter system" Medical Device Product
March 25, 2015 HPB/EAD0325 No.1 PFSB/ELD/OMDE/C0325 No.5 PFSB/SD0325 No.1	Proper Use of the "NovoTTF-100A system" Medical Device Product
March 20, 2015 PFSB/SD0320 No.1	Adherence to Methods for Cleaning and Sterilization/Disinfection of Duodenoscope Devices
February 17, 2015 HPB/EAD0217 No.1 PFSB/ELD/OMDE/C0217 No.1 PFSB/SD0217 No.2	Proper use of the "COOK lead extraction system" Medical Device Product
December 26, 2014 PFSB/ELD/OMDE/C1226 No.1 PFSB/SD1226 No.6	Proper Use and Post-marketing Safety Measures of Gel-filled Breast Implants and Tissue Expander Products
December 25, 2014 HPB/EAD1225 No.4 PFSB/ELD/OMDE/C1225 No.1 PFSB/SD1225 No.1	Proper Use of the "COOK needle's eye snare" Medical Device Product
December 18, 2014 PFSB/SD1218 No.1	Implementation of Appropriate Methods for the Handling and Maintenance of Automated External Defibrillators (AEDs) in Cold Climates
November 13, 2014 PFSB/ELD/OMDE/C1113 No.4 PFSB/SD1113 No.1	Proper Use of the "Embosphere" and "HepaSphere" Medical Device Products
October 1, 2014 PFSB1001 No.3	Ensuring the Provision of Information related to the Proper Use of Contact Lenses (reminder)
September 17, 2014 HPB/EAD0917 No.1 PFSB/ELD/OMDE/C0917 No.7 PFSB/SD0917 No.1	Proper Use of the "Alair bronchial thermoplasty system" Medical Device Product
August 19, 2014 HPB/GAD0819 No.1 PFSB/SD0819 No.1	Guidelines for the Use of Mobile-phones etc. at Medical Institutions Prepared by Electromagnetic Compatibility Conference Japan
July 10, 2014 HPB/EAD0710 No.1 PFSB/ELD0710 No.1 PFSB/SD0710 No.1	Proper Use of the "ACCULOC gold marker" Medical Device Product
June 19, 2014 PFSB/SD0619 No.1	Dissemination of Information concerning the Handling of Single-use Medical Devices
June 4, 2014 Administrative Notice	Issuance of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices (FY 2014 edition) Compiled by the Ministry of Internal Affairs and Communications Reference: Results of the FY 2013 Investigation on the Influence of Radio Waves on Medical Devices, etc. and subsequent Revision of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices	(Link)
February 24, 2014 HPB/EAD0224 No.1 PFSB/ELD0224 No.6 PFSB/SD0224 No.4	Proper Use of the "AERO Tracheobronchial Hybrid Stent" Medical Device Product
February 19, 2014 HPB/EAD0219 No.1 PFSB/ELD0219 No.1 PFSB/SD0219 No.1	Proper Use of the "Arctic Front Advance Cryoablation Catheter" and other related Medical Device Products
January 10, 2014 Administrative Notice	Issuance of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices (FY 2013 edition) compiled by the Ministry of Internal Affairs and Communications Reference: Results of the FY 2012 Investigation on the Influence of Radio Waves on Medical Devices, etc. and subsequent Revision of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices	(Link)
December 20, 2013 HPB/EAD1220 No.1 PFSB/ELD1220 No.10 PFSB/SD1220 No.7	Proper Use of the "HOYA CTR" Medical Device Product
November 22, 2013 HPB/EAD1122 No.4 PFSB/ELD1122 No.8 PFSB/SD1122 No.4	Proper Use of the "Jarvik 2000 ventricular assist device" Medical Device Product
November 22, 2013 HPB/EAD1122 No.1 PFSB/ELD1122 No.5 PFSB/SD1122 No.1	Proper Use of the "Wingspan stent" Medical Device Product
September 27, 2013 PFSB/SD0927 No.1	Implementation of Appropriate Methods for Handling and Maintenance of Automated External Defibrillators (AEDs) (reminder) (Notification by the Director of the Safety Division, Pharmaceuticals and Food Safety Bureau, MHLW)
September 27, 2013 HPB0927 No.6 PFSB0927 No.1 HPB0927 No.7 PFSB0927 No.2	Implementation of Appropriate Methods for Handling and Maintenance of Automated External Defibrillators (AEDs) (reminder) (Notification by the Secretary-General of the Health Policy Bureau and the Pharmaceuticals and Food Safety Bureau, MHLW)
September 20, 2013 HPB/EAD0920 No.1 PFSB/ELD0920 No.1 PFSB/SD0920 No.1	Proper Use of the "Med-El cochlear implant EAS" Medical Device Product
July 23, 2013 HPB/EAD0723 No.1 PFSB/ELD0723 No.1 PFSB/SD0723 No.1	Proper Use of the "LifeVest wearable defibrillator" Medical Device Product
June 28, 2013 PFSB0628 No.17	Ensuring the Provision of Information Related to the Proper Use of Contact Lenses (Reminder) Reference: Research concerning Appropriate Marketing Regulations Based on the Results of a Survey of Actual Retail Statistics for Contact Lenses
June 21, 2013 HPB/EAD0621 No.9 PFSB/ELD0621 No.1 PFSB/SD0621 No.3	Proper Use of the "Embosphere" Medical Device Product
June 21, 2013 HPB/EAD0621 No.15 PFSB/ELD0621 No.4 PFSB/SD0621 No.6	Proper Use of the "HepaSphere" Medical Device Product
April 19, 2013 HPB/EAD0419 No.1 PFSB/ELD0419 No.1 PFSB/SD0419 No.1	Proper Use of the "DC Bead" Medical Device Product
April 19, 2013 HPB/EAD0419 No.4 PFSB/ELD0419 No.4 PFSB/SD0419 No.4	Proper Use of the "Histoacryl" Medical Device Product
April 19, 2013 HPB/EAD0419 No.7 PFSB/ELD0419 No.7 PFSB/SD0419 No.7	Proper Use of the "Activa RC" Medical Device Product
February 8, 2013 Administrative Notice	Issuance of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices (Revised in FY 2012) Issued by Ministry of Internal Affairs and Communications Reference: Result of the Public Comments on the Draft Revision and Subsequent Revision of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices	(Link)
December 11, 2012 PFSB1211 No.8	Self-inspection of Pharmaceuticals and Medical Devices, etc. Manufactured using Materials Derived from Bovin Specimens, etc. Originating from Brazil
September 28, 2012 HPB/EAD0928 No.5 PFSB/ELD0928 No.4 PFSB/SD0928 No.1	Proper Use of the "Contegra Pulmonary Valved Conduit" Medical Device Product
July 18, 2012 PFSB0718 No.16	Required Procedures at the Time of Sale of Contact Lenses
July 18, 2012 PFSB0718 No.15	Ensuring the Provision of Information related to Proper Use of Contact Lenses
May 10, 2012 PFSB/SD0510 No.1	Dissemination of Information concerning the Proper Use of Electric Massagers for Household Use (request for cooperation)
March 29, 2012 HPB/EAD0329 No.4 PFSB/ELD0329 No.7 PFSB/SD0329 No.3	Proper Use of the "Advisa MRI" and "CapSureFix MRI lead" Medical Device Products Manufactured by Medtronic
August 31, 2011 HPB/EAD0831 No.1 PFSB/ELD0831 No.4 PFSB/SD0831 No.1	Proper Use of the "Baerveldt Glaucoma Implant" Medical Device Product
July 29, 2011 PFSB/SD0729 No.1	Promotion of the Use of the PMDA medi-navi (request) Appendix: Summary of the Meeting to Exchange Opinions concerning the Promotion of the Pharmaceutical and Medical Device Information E-mail Alert Service
July 15, 2011 Administrative Notice	Q&A concerning the Guidelines for Issuance of Dear Healthcare Professional Letters of Emergent/Rapid Safety Communications
June 9, 2011 HPB/EAD0609 No.1 PFSB/ELD0609 No.1 PFSB/SD0609 No.1	Proper Use of the "Penumbra System" Medical Device Product
June 1, 2011 Administrative Notice	Issuance of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices (Revised in May 2011) Compiled by Ministry of Internal Affairs and Communications Reference: Ministry of Internal Affairs and Communications Website: Results of a Survey to Investigate the Influence of Radio Waves Emitted by WiMAX Wireless Communication Devices on Implantable Medical Devices such as Cardiac Pacemakers	(Link)
March 31, 2011 PFSB/SD0331 No.4	Post-marketing Safety Measures for Plazma Gas Sterilizers
March 22, 2011 Administrative Notice	Notice concerning Pharmaceuticals and Medical Device Safety Measures in Response to the Tohoku Pacific Coast Earthquake
March 17, 2011 PFSB0317 No.6	Designation of a Regulatory Action to Specify August 31, 2011 as the Expiration Date in Line with an Extension of the Term for the Specified Rights and Interests Set Forth in Article 3-1 of the Act Regarding Special Measures to Ensure the Preservation of Rights and Profits of the Victims of Specified Extraordinary Disasters Pursuant to the Povisions of Article 2 of the Act
August 16, 2010 Administrative Notice	Correction of the Notification concerning Ensuring Management of Medical Device Recalls for Products such as Jackson-Rees Circuits
July 26, 2010 PFSB0726 No.3	Ensuring Management of Medical Device Recalls for Products such as Jackson-Rees Circuits (request)
May 25, 2010 Administrative Notice	Issuance of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices (Revised in May 2010) Compiled by Ministry of Internal Affairs and Communications Reference: Ministry of Internal Affairs and Communications Website: Results of a Survey to Investigate the Influence of Mobile-phones on Implantable Medical Devices such as Cardiac Pacemakers	(Link)
May 7, 2010 PFSB/SD0507 No.1 PFSB/CND0507 No.5 PFSB/ELD/OMDE0507 No.11	Dissemination of Information concerning Proper Management, etc. of Automated External Defibrillators (AEDs) (request)
April 30, 2010 HPB/EAD0430 No.1 PFSB/ELD0430 No.1 PFSB/SD0430 No.1	Proper Use of the "Merci Retriever" Medical Device Product
March 30, 2010 PFSB/SD0330 No.1 PFSB/ELD/OMDE0330 No.1	Handling of Automated External Defibrillators (AEDs) by Fire Authorities (request)
January 18, 2010 Administrative Notice	Confirmation of AC Power Cords Produced by the Electri-Cord Manufacturing Company (request)
December 16, 2009 PFSB/ELD1216 No.1 PFSB/SD1216 No.6 PFSB/ELD1216 No.3 PFSB/SD1216 No.8 PFSB/ELD1216 No.4 PFSB/SD1216 No.9	Ensuring the Provision of Information related to the Proper Use, etc. of Disinfectant Solutions for Soft Contact Lenses Reference: National Consumer Affairs Center of Japan Website: Effectiveness of Disinfectant Solutions for Soft Contact Lenses Against Acanthamoeba: Results of a Survey of Contact Lens Care Methods	(Link) (Link)
December 3, 2009 PFSB/SD1203 No.1 PFSB/SD1203 No.2	Complications associated with Long-term Use of the MIRAgel Explant (request for circulation)
June 3, 2009 Administrative Notice	Issuance of the Guidance concerning Avoidance of Radio Wave Disruption Caused by Various Radio Wave-emitting Devices Found in Implantable Medical Devices (Revised in May 2009) Compiled by Ministry of Internal Affairs and Communications
April 16, 2009 PFSB/SD No.0416001	Implementation of Appropriate Methods for Handling and Maintenance of Automated External Defibrillators (AEDs)
April 16, 2009 HPB No.0416001 PFSB No.0416001 HPB No.0416002 PFSB No.0416002 HPB No.0416003 PFSB No.0416003	Implementation of Appropriate Methods for Handling and Maintenance of Automated External Defibrillators (AEDs) (Raising Awareness and Request for Circulation among Relevant Organizations) Reference 1: "Are you performing regular checks of AEDs?" Reference 2: FAQ regarding Implementation of Appropriate Methods for Handling and Maintenance of AEDs Reference 3: List of AED Products Reference 4: List of Major Facilities that have Installed AEDs
December 22, 2008 HPB/RDD No.1222001 PFSB/ELD No.1222001 PFSB/SD No.1222001	Proper Use of the "VEPTR" Medical Device Product	(Link)
December 16, 2008 PFSB/SD No.1216001	Provision of Information concerning the Proper Use of Electric Massagers for Household Use
November 19, 2008 PFSB/SD No.1119001	Recall, etc. of Jackson-Rees Circuits (Raising Awareness and Request for Circulation)
September 26, 2008 HPB/RDD No.0926002 PFSB/ELD No.0926001 PFSB/SD No.0926004	Proper Use of Liquid Obstructing Material for the Cranial Nerve Region	(Link)
July 11, 2008 HPB/RDD No.0711001 PFSB/ELD No.0711002 PFSB/SD No.0711001	Proper Use of Insertable Cardiac Monitors	(Link)
July 1, 2008 HPB/RDD No.0701001 PFSB/ELD No.0701004 PFSB/SD No.0701001	Proper Use of Excimer Laser Cardiac Lead Removal System	(Link)
June 19, 2008 HPB/RDD No.0619001 PFSB/ELD No.0619001 PFSB/SD No.0619001	Proper Use of Thoracic Aortic Aneurysm Stent Grafts	(Link)
September 28, 2007 HPB/RDD No.0928001 PFSB/ELD No.0928007 PFSB/SD No.0928001	Proper Use of Carotid Artery Stents	(Link)
September 14, 2007 HPB/GAD No.0914001 PFSB/SD No.0914001	Voluntary Recall, etc. of Manual Lung Resuscitators (request)	(Link)
April 20, 2007 PFSB/ELD No.0420006 PFSB/SD No.0420004	Request for Cooperation with Safety Measures for Ticlopidine Hydrochloride Products and TAXUS Express2 Stents	(Link)
November 9, 2006 PFSB/SD No.1109002	Response to Inquiries by Healthcare Professionals regarding the Influence of Power/Telephone Lines on Medical Devices	(Link)
November 9, 2006 PFSB/SD No.1109001	Guidance for Applicants related to Type Designations for Different Influences on Medical Devices caused by Power/Telephone Lines (request)	(Link)
March 17, 2003 PB/SD No.0317002	Medical Devices such as Transfusion Sets or Catheters that Do Not Contain DEHP	(Link)
March 17, 2003 HPB/GAD No. 0317001 PB/SD No.0317010	Research and Interim Report on the Preparation of a Safety Manual regarding Artificial Heart/Lung Devices	(Link)
January 20, 2003 PB/SD No.0120004	Guidance for Related Business Operators regarding Electromagnetic/Electric Home Appliances including Induction Heating (IH) Electronic Rice Cookers	(Link)
October 17, 2002 PB/SD No.1017001 PB/SD No.1017002 PB/SD No.1017003	Elution of the Diethylhexyl Phthalate (DEHP) Plasticizing Agent from Medical Devices Manufactured Using Polyvinyl Chloride	(Link)
March 30, 2001 PB No.296	Ensured Collection, etc. of Medical Device Safety Information	(Link)