Criteria for in vitro diagnostics

Name: Criteria for in vitro diagnostics
Creator: Pharmaceuticals and Medical Devices Agency
Keywords: approval,certification,checklists,criteria,diagnostics,in-vitro-diagnostics,ivd,mhlw,principles,regulations,standards

Information

Original link

Type

Regulation

Regulated products

IVDMD

Description

Criteria for in vitro diagnostics - a regulation document outlining the standards for in vitro diagnostic tests.

Organization

Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

Country / Region

Japan

License

Other (Public Domain)

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8 Main files

MHLW Ministerial Announcement No. 121 dated on 29th March, 2005

Updated on October 18, 2023

pdf

URL: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/ivd_cer_00.pdf
Permalink: https://data.openrid.co/en/datasets/r/d3bc3ac5-ca67-4e8e-a7fc-8bb5c7f2484b
MIME Type: application/pdf

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

Certification Criteria - Scope

Updated on February 9, 2024

pdf

URL: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/ivd_cer_01.pdf
Permalink: https://data.openrid.co/en/datasets/r/6eaec76e-6bb5-40ad-a775-6920cc06c9af
MIME Type: application/pdf

Created on: February 9, 2024
Modified on: February 9, 2024

Certification Criteria - Technical Standards

Updated on October 18, 2023

pdf

URL: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/ivd_cer_02.pdf
Permalink: https://data.openrid.co/en/datasets/r/b192f5cc-5135-49df-90a7-c2939eb830b8
MIME Type: application/pdf

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

Certification Criteria - Essential Principle Checklist

Updated on October 18, 2023

pdf

URL: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/ivd_cer_03.pdf
Permalink: https://data.openrid.co/en/datasets/r/ef99cb5a-343b-4570-a68d-3f9411a6f019
MIME Type: application/pdf

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

Approval Criteria - Scope

Updated on February 9, 2024

pdf

URL: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/ivd_app_01.pdf
Permalink: https://data.openrid.co/en/datasets/r/f7e99559-2082-436e-9c2c-57b5b1d63255
MIME Type: application/pdf

Created on: February 9, 2024
Modified on: February 9, 2024

Approval Criteria - Technical Standards

Updated on October 18, 2023

pdf

URL: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/ivd_app_02.pdf
Permalink: https://data.openrid.co/en/datasets/r/a07b48b1-03a4-487b-8dcd-62f429a68901
MIME Type: application/pdf

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

Approval Criteria - Essential Principle Checklist

Updated on October 18, 2023

pdf

URL: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/ivd_app_03.pdf
Permalink: https://data.openrid.co/en/datasets/r/8ed7ac1a-87a7-4fb2-98f1-c611cf215a13
MIME Type: application/pdf

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

MHLW Ministerial Announcement No. 120 dated on 29th March, 2005

Updated on October 18, 2023

pdf

URL: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/ivd_exm_00.pdf
Permalink: https://data.openrid.co/en/datasets/r/ff9a0e47-ff8d-42a1-9158-4beb5dac625a
MIME Type: application/pdf

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

Criteria for in vitro diagnostics

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Type

Regulated products

Description

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Country / Region

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