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Reviews and Related Services

Medical Devices

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/C​ertification 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

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

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