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Notifications Related to Safety Measures (Medical Devices)

Notification

Date Title Original in Japanese
(PDF or Link)
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
PDF
PDF
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.

PDF
PDF
November 15, 2019
Administrative Notice
Questions and Answers (Q&A) on MR Safety of Implantable Medical Devices, etc. PDF
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)
PDF
PDF
PDF
PDF
PDF
November 11, 2019
Administrative Notice
Education to Elementary and Middle School Children for Proper Use of Contact Lenses: Publication of Educational Material PDF
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)
PDF
PDF
PDF
PDF
PDF
August 1, 2019
PSEHB/MDED No.0801-1
PSEHB/PSD No.0801-4
Measures for MR Safety in Implantable Medical Devices, etc. PDF
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.
PDF
PDF
July 24, 2018
PSEHB/MDED0724 No.1
PSEHB/PSD0724 No.1
Guidance on Ensuring Cyber Security of Medical Devices PDF
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 PDF
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 PDF
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) PDF
September 26, 2017
PSEHB0926 No.5
Dissemination of Information etc. Related to Proper Use of Contact Lenses PDF
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 PDF
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 PDF
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 PDF
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 PDF
June 20, 2017
PSEHB/MDED0620 No.3
PSEHB/SD0620 No.1
Proper Use of the "EDWARDS INTUITY Elite Valve System" Medical Device Product PDF
January 10, 2017
PSEHB/MDED0110 No.4
PSEHB/SD0110 No.6
Proper Use of the "Long-pulse Alexandrite Laser GentleLase Pro" Medical Device Product PDF
December 27, 2016
PSEHB/MDED1227 No.1
PSEHB/SD1227 No.1
Handling of Powdered Medical Gloves   PDF
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
PDF
(Link)
November 22, 2016
PSEHB/MDED1122 No.7
PSEHB/SD1122 No.4
Proper Use of the "HeartFlow FFRCT" Medical Device Product PDF
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
PDF
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 PDF
January 22, 2016
Administrative Notice
Efforts to Raise Awareness of the Proper Use of Electric Massagers for Household Use (information provision) PDF
December 21, 2015
Administrative Notice
Precautions concerning Malfunction etc. Reports for Medical Device Programs, etc. PDF
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 PDF
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
PDF
(Link)
 
August 27, 2015
PFSB/SD0827 No.1
Reminder concerning Information related to the Handling, etc. of Single-use Medical Devices PDF
August 10, 2015
Administrative Notice
Activities related to Promoting Awareness and Understanding of the Proper Use of Colored Contact Lenses PDF
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 PDF
April 28, 2015
PFSB/ELD/OMDE/C0428 No.1
PFSB/SD0428 No.1
Ensuring Cyber Security of Medical Devices PDF
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 PDF
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 PDF
March 20, 2015
PFSB/SD0320 No.1
Adherence to Methods for Cleaning and Sterilization/Disinfection of Duodenoscope Devices PDF
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 PDF
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 PDF
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 PDF
December 18, 2014
PFSB/SD1218 No.1
Implementation of Appropriate Methods for the Handling and Maintenance of Automated External Defibrillators (AEDs) in Cold Climates PDF
November 13, 2014
PFSB/ELD/OMDE/C1113 No.4
PFSB/SD1113 No.1
Proper Use of the "Embosphere" and "HepaSphere" Medical Device Products PDF
October 1, 2014
PFSB1001 No.3
Ensuring the Provision of Information related to the Proper Use of Contact Lenses (reminder) PDF
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 PDF
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 PDF
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 PDF
June 19, 2014
PFSB/SD0619 No.1
Dissemination of Information concerning the Handling of Single-use Medical Devices PDF
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
PDF
(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 PDF
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 PDF
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
PDF
(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 PDF
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 PDF
November 22, 2013
HPB/EAD1122 No.1
PFSB/ELD1122 No.5
PFSB/SD1122 No.1
Proper Use of the "Wingspan stent" Medical Device Product PDF
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) PDF
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) PDF
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 PDF
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 PDF
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
PDF
PDF
June 21, 2013
HPB/EAD0621 No.9
PFSB/ELD0621 No.1
PFSB/SD0621 No.3
Proper Use of the "Embosphere" Medical Device Product PDF
June 21, 2013
HPB/EAD0621 No.15
PFSB/ELD0621 No.4
PFSB/SD0621 No.6
Proper Use of the "HepaSphere" Medical Device Product PDF
April 19, 2013
HPB/EAD0419 No.1
PFSB/ELD0419 No.1
PFSB/SD0419 No.1
Proper Use of the "DC Bead" Medical Device Product PDF
April 19, 2013
HPB/EAD0419 No.4
PFSB/ELD0419 No.4
PFSB/SD0419 No.4
Proper Use of the "Histoacryl" Medical Device Product PDF
April 19, 2013
HPB/EAD0419 No.7
PFSB/ELD0419 No.7
PFSB/SD0419 No.7
Proper Use of the "Activa RC" Medical Device Product PDF
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
PDF
(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 PDF
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 PDF
July 18, 2012
PFSB0718 No.16
Required Procedures at the Time of Sale of Contact Lenses PDF
July 18, 2012
PFSB0718 No.15
Ensuring the Provision of Information related to Proper Use of Contact Lenses PDF
May 10, 2012
PFSB/SD0510 No.1
Dissemination of Information concerning the Proper Use of Electric Massagers for Household Use (request for cooperation) PDF
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 PDF
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 PDF
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
PDF
PDF
July 15, 2011
Administrative Notice
Q&A concerning the Guidelines for Issuance of Dear Healthcare Professional Letters of Emergent/Rapid Safety Communications PDF
June 9, 2011
HPB/EAD0609 No.1
PFSB/ELD0609 No.1
PFSB/SD0609 No.1
Proper Use of the "Penumbra System" Medical Device Product PDF
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
PDF
(Link)
March 31, 2011
PFSB/SD0331 No.4
Post-marketing Safety Measures for Plazma Gas Sterilizers PDF
March 22, 2011
Administrative Notice
Notice concerning Pharmaceuticals and Medical Device Safety Measures in Response to the Tohoku Pacific Coast Earthquake PDF
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 PDF
August 16, 2010
Administrative Notice
Correction of the Notification concerning Ensuring Management of Medical Device Recalls for Products such as Jackson-Rees Circuits PDF
July 26, 2010
PFSB0726 No.3
Ensuring Management of Medical Device Recalls for Products such as Jackson-Rees Circuits (request) PDF
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
PDF
(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) PDF
April 30, 2010
HPB/EAD0430 No.1
PFSB/ELD0430 No.1
PFSB/SD0430 No.1
Proper Use of the "Merci Retriever" Medical Device Product PDF
March 30, 2010
PFSB/SD0330 No.1
PFSB/ELD/OMDE0330 No.1
Handling of Automated External Defibrillators (AEDs) by Fire Authorities (request) PDF
January 18, 2010
Administrative Notice
Confirmation of AC Power Cords Produced by the Electri-Cord Manufacturing Company (request) PDF
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
PDF
(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) PDF
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 PDF
April 16, 2009
PFSB/SD No.0416001
Implementation of Appropriate Methods for Handling and Maintenance of Automated External Defibrillators (AEDs) PDF
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
PDF
PDF
PDF
PDF
PDF
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 PDF
November 19, 2008
PFSB/SD No.1119001
Recall, etc. of Jackson-Rees Circuits (Raising Awareness and Request for Circulation) PDF
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)

 

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Notifications Related to Safety Measures (Medical Devices)
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