Medical Devices

Links to major regulatory information of Medical Devices.

 

Regulations and Notifications

Conditional Approval System

• Conditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme)[280.09KB]

July 31, 2017 PSEHB Notification No. 0731-1

 

Reprocessed Single-use Medical Devices

• Amendment of the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics related to Reprocessed Single-Use Medical Devices (R-SUDs)[156.81KB]

July 31, 2017 PSEHB Notification No. 0731-7

 

• Points to Consider for Reprocessed Single-use Medical Devices[163.01KB]

July 31, 2017 PSEHB/MDE Notification No. 0731-8 PSEHB/PSD Notification No. 0731-5 PSEHB/CND Notification No. 0731-1

 

• Points to Consider for the Preparation of Applications for Marketing Approval of Remanufactured Single-use Medical Devices[226.02KB]

August 16, 2017 PSEHB/MDE Notification No. 0816-3

 

• Points to Consider for Preparation of Attached Data to Application Form for Marketing Approval of Reprocessed Single-use Medical Devices[178.85KB]

August 16, 2017 PSEHB/MDE Notification No. 0816-6

 

• Amendment of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostics related to reprocessed single-use medical devices (R-SUDs)[165.58KB]

July 31, 2017 PSEHB/CND Notification No. 0731-12

 

Review for Approval／C​ertification of Medical Devices

• Questions and Answers (Q&A) on the Application for Confirmation of Change Plans for Medical Devices, Medical Devices Utilizing Artificial Intelligence-Related Technologies, and Program Medical Devices[277.41KB]

December 22, 2023 PSB/MDED Administrative Notice

 

• Handling of Performance Evaluation Tests of Diagnostic Medical Devices Using Existing Medical Image Data without Involvement of Additional Invasiveness or Intervention[112.58KB]

September 29, 2021 PSEHB/MDED Notification No.0929-1

 

• Handling of the Conditional Approval of Medical Devices and In Vitro Diagnostic Pharmaceuticals[119.79KB]

August 31, 2020 PSEHB/MDED Notification No. 0831 (2)

 

• Handling Application for Confirming Change Plans for Medical Devices[86.57KB]

August 31, 2020 PSEHB/MDED Notification No. 0831-14

 

• Handling of Situations requiring submission of “Documents related to Clinical Study Results” for Medical Devices (Responses based on Measures across Pre-and Post-Marketing Phases)[206.00KB]

November 17, 2017 PSEHB/MDED Notification No. 1117 (1) PSEHB/PSD Notification No. 1117 (1)

 

• Release of Clinical Trial Guidance to Facilitate the Speedy and Accurate Approval and Development of Medical Devices[601.46KB]

November 17, 2017 PSEHB/MDED Administrative Notice

 

Clinical Trials in Foreign Countries

• Handling of the data of clinical studies for medical devices conducted in foreign countries[24.17KB]

March 31, 1997 PAB/MHW Notification No. 479

 

• Handling of clinical study data on medical devices which was carried out in foreign countries[23.64KB]

March 31, 2006 PFSB/MDE Notification No. 0331006

 

• Q & A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign Countries[54.35KB]

June 23, 2006 PFSB/ELD/ OMDE Administrative Notice

 

Software as a Medical Device

• Q&A about “Handling of the Two-step Approval Based on the Characteristics of Software as a Medical Device”[114.05KB]

June 12, 2024 PSB/MDED Administrative Notice

 

• Handling of the Two-step Approval Based on the Characteristics of Software as a Medical Device[65.20KB]

November 16, 2023 PSB/MDED Notification No. 1116-2

 

• Handling of Medical Device Software[113.60KB]

November 21, 2014 PFSB/MDRMPED Notification No. 1121-33 PFSB/SD Notification No. 1121-1 PFSB/CND Notification No. 1121-29

 

• Questions & Answers about Handling of Medical Device Software[136.76KB]

November 25, 2014 PFSB/MDRMPED Administrative Notice

 

• Handling of Application for Marketing Certification of Medical Device Software[90.81KB]

November 25, 2014 PFSB/MDRMPED Notification No. 1125-6

 

• Notice concerning the Publication of Guidance Materials concerning Application for Marketing Approval of Medical Device Software[205.00KB]

March 31, 2016 PFSB/MDRMPED Administrative Notice

 

Other related Notifications 

• Partial Revision of “Partial Revision of the “Points to Consider for Approval Applications for Home Medical Devices to Detect Signs of Diseases and to Encourage Medical Consultation””[143.83KB]

June 21, 2024 PSB/MDED Notification No. 0621-1 PSB/PSD Notification No. 0621-1

 

• Examples of Points to Consider and Approaches for Utilization of Study Results Obtained from Specified Clinical Research in Applications for Approval of Medical Devices and Regenerative Medical Products[133.93KB]

June 5, 2024 PSB/MDED Administrative Notice

 

• Procedures for Public Release of Information on Review of Applications for New Medical Devices[59.25KB]

February 6, 2009 PMDA Notification No. 0206007

 

Related Information

Issuance of Certificates for Export

• Issuance of Certificates for Medical Devices for Export

Presentations

• PMDA’s Activities Leading to Medical Device Innovation [3.16 MB]

August, 2024

 

Related Links

• Regulations and Approval/Certification of Medical Devices
• Revision of Japanese Medical Device QMS requirements
• Notification of the Guidance for the Evaluation of Emerging Technology Medical Devices(unofficial English version) (links to the website of the National Institute of Health Sciences)