Links to major regulatory information of Medical Devices.
Regulations and Notifications
Conditional Approval System
July 31, 2017 PSEHB Notification No. 0731-1
Reprocessed Single-use Medical Devices
July 31, 2017 PSEHB Notification No. 0731-7
July 31, 2017 PSEHB/MDE Notification No. 0731-8 PSEHB/PSD Notification No. 0731-5 PSEHB/CND Notification No. 0731-1
August 16, 2017 PSEHB/MDE Notification No. 0816-3
August 16, 2017 PSEHB/MDE Notification No. 0816-6
July 31, 2017 PSEHB/CND Notification No. 0731-12
Review for Approval/Certification of Medical Devices
September 29, 2021 PSEHB/MDED Notification No.0929-1
November 17, 2017 PSEHB/MDED Notification No.1117-1 PSEHB/SD Notification No.1117-1
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
March 31, 2006 PFSB/MDE Notification No. 0331006
June 23, 2006 PFSB/ELD/ OMDE Administrative Notice
Software as a Medical Device
November 21, 2014 PFSB/MDRMPED Notification No. 1121-33 PFSB/SD Notification No. 1121-1 PFSB/CND Notification No. 1121-29
November 25, 2014 PFSB/MDRMPED Administrative Notice
November 25, 2014 PFSB/MDRMPED Notification No. 1125-6
March 31, 2016 PFSB/MDRMPED Administrative Notice
Other related Notifications
- (Before Amendment) Partial Revision of the “Points to Consider for Approval Applications for Home Medical Devices to Detect Signs of Diseases and to Encourage Medical Consultation”[127.54KB](Note)
December 13, 2022 PSEHB/MDED Notification No. 1213-4 PSEHB/PSD Notification No. 1213-3
(Note)The latest version is available only in Japanese.
June 21, 2024 PSB/MDED Notification No. 0621-1 PSB/PSD Notification No. 0621-1
February 6, 2009 PMDA Notification No. 0206007
Related Information
Issuance of Certificates for Export
Presentations
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)