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Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

Description

The Pharmaceuticals and Medical Devices Agency is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan.

Official website

https://www.pmda.go.jp/english/index.html

Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PMDA/CPE Notification No. 325

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Updated on July 3, 2023

Other (Public Domain)

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Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in Utilization of Data from Registry or Medical Information Database in Applications for Marketing Approval and Re-examination for Regenerative Medical Products

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDED Administrative Notice

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Updated on March 31, 2023

Other (Public Domain)

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Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/PED Notification No. 0330-6 PSEHB/MDED Notification No. 0330-1

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Updated on March 30, 2023

Other (Public Domain)

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

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDED Notification No. 1213-4 PSEHB/PSD Notification No. 1213-3

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Updated on December 13, 2022

Other (Public Domain)

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Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PMDA/CPE Notification No. 0525001

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Updated on May 25, 2022

Other (Public Domain)

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Handling of Performance Evaluation Tests of Diagnostic Medical Devices Using Existing Medical Image Data without Involvement of Additional Invasiveness or Intervention

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDED Notification No.0929-1

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Updated on September 29, 2021

Other (Public Domain)

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Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/PED Notification No. 0323-2 PSEHB/MDED Notification No. 0323-2

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Updated on March 23, 2021

Other (Public Domain)

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Basic principles on Utilization of Registry for Applications

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/PED Notification No. 0323-1 PSEHB/MDED Notification No. 0323-1

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Updated on March 23, 2021

Other (Public Domain)

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Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical products

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PMDA/CPE Notification No. 1116002

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Updated on November 16, 2020

Other (Public Domain)

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Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Regenerative Medical Products

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDED Notification No. 0323-4

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Updated on March 23, 2020

Other (Public Domain)

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Guideline on Ensuring the Quality and Safety of Gene Therapy Products

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDED Notification No.0709-2

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Updated on July 9, 2019

Other (Public Domain)

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Guidelines on Cancer Immunotherapy Development

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/PED Notification No. 0308-1 PSEHB/MDED Notification No.0308-1

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Updated on March 8, 2019

Other (Public Domain)

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Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Medical Devices

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDED Notification No. 1219-4

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Updated on December 19, 2018

Other (Public Domain)

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Handling on the Scope of Situations where “Documents related to Clinical Study Results” is Necessary on Medical Devices (Operations based on Measures through Pre-and Post-Marketing Phases)

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDED Notification No.1117-1 PSEHB/SD Notification No.1117-1

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Updated on November 17, 2017

Other (Public Domain)

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Release of Clinical Trial Guidance to Facilitate the Speedy and Accurate Approval and Development of Medical Devices

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDED Administrative Notice

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Updated on November 17, 2017

Other (Public Domain)

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Points to Consider for Preparation of Attached Data to Application Form for Marketing Approval of Reprocessed Single-use Medical Devices

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDE Notification No. 0816-6

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Updated on August 16, 2017

Other (Public Domain)

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Points to Consider for the Preparation of Applications for Marketing Approval of Remanufactured Single-use Medical Devices

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDE Notification No. 0816-3

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Updated on August 16, 2017

Other (Public Domain)

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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)

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/CND Notification No. 0731-12

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Updated on July 31, 2017

Other (Public Domain)

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Points to Consider for Reprocessed Single-use Medical Devices

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB/MDE Notification No. 0731-8 PSEHB/PSD Notification No. 0731-5 PSEHB/CND Notification No. 0731-1

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Updated on July 31, 2017

Other (Public Domain)

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Conditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme)

From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

PSEHB Notification No. 0731-1

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Updated on July 31, 2017

Other (Public Domain)

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