Revision of Japanese Medical Device QMS requirements

Name: Revision of Japanese Medical Device QMS requirements
Creator: Pharmaceuticals and Medical Devices Agency
Keywords: enforcement,japan,medical-devices,mhlw,qms,quality,quality-management-system,regulations,requirements,safety,standards,tables

Information

Original link

Type

Miscellaneous

Regulated products

Medical Devices

Topics

Reviews And Related Services

Description

This document discusses the revision of quality management system requirements for medical devices in Japan.

Organization

Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

Country / Region

Japan

License

Other (Public Domain)

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10 Main files

Revision of Japanese Medical Device QMS requirements

Updated on April 10, 2024

html

URL: https://www.pmda.go.jp/english/review-services/regulatory-info/0004.html
Permalink: https://data.openrid.co/en/datasets/r/d30db5a0-3814-44f8-9df8-eb98f0dff7bc
MIME Type: text/html

Created on: April 10, 2024
Modified on: April 10, 2024

Comparison table between ISO13485:2016 and MHLW MO169 Chapter 2, as revised in 2021

Updated on October 18, 2023

pdf

URL: https://www.pmda.go.jp/files/000239873.pdf
Permalink: https://data.openrid.co/en/datasets/r/5056e155-15cd-43c2-a593-c7eed948fbef
MIME Type: application/pdf

Created on: October 18, 2023
Modified on: October 18, 2023

Comparison table between ISO13485:2003 and MHLW MO169 Chapter 2, as revised in 2014

Updated on October 18, 2023

pdf

URL: https://www.pmda.go.jp/files/000239870.pdf
Permalink: https://data.openrid.co/en/datasets/r/57a660a2-f6b1-440b-962e-00757bc77bb4
MIME Type: application/pdf

Created on: October 18, 2023
Modified on: October 18, 2023

Tentative translation of MHLW MO169 Chapter 3, as revised in 2021

Updated on October 18, 2023

pdf

URL: https://www.pmda.go.jp/files/000239874.pdf
Permalink: https://data.openrid.co/en/datasets/r/7ceaa41d-3ebe-416c-9225-f343daecca1e
MIME Type: application/pdf

Created on: October 18, 2023
Modified on: October 18, 2023

Tentative translation of MHLW MO169 Chapter 3, as revised in 2014

Updated on October 18, 2023

pdf

URL: https://www.pmda.go.jp/files/000239871.pdf
Permalink: https://data.openrid.co/en/datasets/r/eafe25f8-cadf-440b-a7a5-c4a7e28da13a
MIME Type: application/pdf

Created on: October 18, 2023
Modified on: October 18, 2023

Tentative translation of MHLW MO169 Chapter 4, as revised in 2021

Updated on October 18, 2023

pdf

URL: https://www.pmda.go.jp/files/000248602.pdf
Permalink: https://data.openrid.co/en/datasets/r/15331432-7a2a-45cf-a85d-e6fb8742d305
MIME Type: application/pdf

Created on: October 18, 2023
Modified on: October 18, 2023

Tentative translation of MHLW MO169 Chapter 5, as revised in 2021

Updated on October 18, 2023

pdf

URL: https://www.pmda.go.jp/files/000248603.pdf
Permalink: https://data.openrid.co/en/datasets/r/f511b897-1de7-4088-9818-4e1a2bc10514
MIME Type: application/pdf

Created on: October 18, 2023
Modified on: October 18, 2023

Tentative translation of MHLW MO169 Chapter 5-2, as revised in 2021

Updated on October 18, 2023

pdf

URL: https://www.pmda.go.jp/files/000248604.pdf
Permalink: https://data.openrid.co/en/datasets/r/0ae04017-5fdf-468a-be57-bbeb7dd0bfee
MIME Type: application/pdf

Created on: October 18, 2023
Modified on: October 18, 2023

Tentative translation of MHLW MO1 (Regulations for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices)

Updated on October 18, 2023

pdf

URL: https://www.pmda.go.jp/files/000248606.pdf
Permalink: https://data.openrid.co/en/datasets/r/20119589-e495-44de-93d6-01f65ae9ceb6
MIME Type: application/pdf

Created on: October 18, 2023
Modified on: October 18, 2023

Standards for Re-manufactured Single-use Medical Devices

Updated on October 18, 2023

pdf

URL: https://www.pmda.go.jp/files/000248607.pdf
Permalink: https://data.openrid.co/en/datasets/r/e9980949-ff37-4108-b0fa-7a1a5ec8ce6d
MIME Type: application/pdf

Created on: October 18, 2023
Modified on: October 18, 2023

Revision of Japanese Medical Device QMS requirements

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Regulated products

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