BACK

Japan

Summarizes and ensures compliance with Japanese regulations.

C-CAT Reports Samples

Size
Published date
C-CATsample_F1_Liquid_CDx.pdf
1.4 MB
Feb 23, 2024
C-CATsample_F1_Liquid_CDx_translation.pdf
1 MB
Feb 23, 2024
C-CATsample_F1CDx-1709131488.pdf
1.4 MB
Feb 28, 2024
C-CATsample_F1CDx_translation-1709131537.pdf
1 MB
Feb 28, 2024
C-CATsample_G360CDx-1709131569.pdf
1.8 MB
Feb 28, 2024
C-CATsample_G360CDx_translation-1709131579.pdf
1.3 MB
Feb 28, 2024
C-CATsample_GenMineTOP-1709131589.pdf
1.5 MB
Feb 28, 2024
C-CATsample_GenMineTOP_translation-1709131600.pdf
1.6 MB
Feb 28, 2024
C-CATsample_Oncoguide-1709131609.pdf
1.6 MB
Feb 28, 2024
C-CATsample_Oncoguide_translation-1709131617.pdf
1.6 MB
Feb 28, 2024

FoundationOne_CDx

Size
Published date
Eng_FoundationOne_CDx_PMDA_label.pdf
782.8 KB
Feb 28, 2024
F1_Cancer_Genome_Profile_Materials_Content.pdf
817.3 KB
Feb 28, 2024
F1_Cancer_Genome_Profile_Materials_Content_translation.pdf
518.6 KB
Feb 28, 2024
F1CDx-Report-Fullmock_prostate_1.pdf
1.4 MB
Feb 28, 2024
F1CDx-Report-Fullmock_Prostate2.pdf
3.9 MB
Feb 28, 2024
FoundationOne_CDx_PMDA_label.pdf
915 KB
Feb 28, 2024
Lecture_07-eng.pdf
2.6 MB
Feb 28, 2024
Lecture_07-jp.pdf
2.6 MB
Feb 28, 2024

FoundationOne_Liquid

Size
Published date
F1LCDx-Quality.pdf
4 MB
Feb 28, 2024
F1LCDx-Quality_translation.pdf
1.1 MB
Feb 28, 2024
PMDA-Label-translation.pdf
484.2 KB
Feb 28, 2024
PMDA-Label.pdf
420.3 KB
Feb 28, 2024
Specimen-instruction_Eng.pdf
480.1 KB
Feb 28, 2024

General Documents

Size
Published date
Guidelines-regarding-program-medical-device-eligibility.pdf
800.5 KB
Feb 28, 2024
Handling-of-medical-device-programs.pdf
171.1 KB
Feb 28, 2024
Partial-revision-of-the-guidelines-regarding-the-medical-device-applicability-of-the-program-March-31,-2020.pdf
1.4 MB
Feb 28, 2024
Approved-program-medical-devices-database.xlsx
70.4 KB
Feb 28, 2024
CDx-perspectives-in-Japan-2018-presentation.pdf
2.2 MB
Feb 28, 2024
CDx-regualation-in-Japan-2019-presentation.pdf
1.2 MB
Feb 28, 2024
Eng-Current-state-of-Genomic-diagnostic.pdf
2 MB
Feb 28, 2024
Eng_Handling-of-medical-device-programs.pdf
288.1 KB
Feb 28, 2024
Eng_Guidelines-regarding-program-medical-device-eligibility.pdf
697.7 KB
Feb 28, 2024
Eng_Ministerial-Ordinance-on-Standards-for-Manufacturing-Control-and-Quality-Control-of-Medical-Devices-(rev-2014).pdf
136.9 KB
Feb 28, 2024
Eng_Partial-revision-of-the-guidelines-regarding-the-medical-device-applicability-of-the-program-March-31,-2020.pdf
2.2 MB
Feb 28, 2024
Eng_PMDA-CDx-list-(Sep-2023).pdf
317.2 KB
Feb 28, 2024

GenMineTOP

Size
Published date
Distributor_Information.pdf
221 KB
Feb 28, 2024
Distributor_Information_translation.pdf
192 KB
Feb 28, 2024
GenMineTOP-Validation-Data-translation.pdf
681.9 KB
Feb 28, 2024
GenMineTOP-Validation-Data.pdf
671.9 KB
Feb 28, 2024
GenMineTOP_consensus_guide.pdf
3.7 MB
Feb 28, 2024
GenMineTOP_consensus_guide_translation.pdf
2 MB
Feb 28, 2024
GenMineTOP_Product_Info.pdf
6.1 MB
Feb 28, 2024
GenMineTOP_Product_Info_translation.pdf
2.6 MB
Feb 28, 2024

Guardant 360

Size
Published date
Distributor_Information-1709134032.pdf
221 KB
Feb 28, 2024
Distributor_Information_translation-1709134040.pdf
192 KB
Feb 28, 2024
GenMineTOP-Validation-Data-translation-1709134048.pdf
681.9 KB
Feb 28, 2024
GenMineTOP-Validation-Data-1709134056.pdf
671.9 KB
Feb 28, 2024
GenMineTOP_consensus_guide-1709134065.pdf
3.7 MB
Feb 28, 2024
GenMineTOP_consensus_guide_translation-1709134075.pdf
2 MB
Feb 28, 2024
GenMineTOP_Product_Info-1709134083.pdf
6.1 MB
Feb 28, 2024
GenMineTOP_Product_Info_translation-1709134090.pdf
2.6 MB
Feb 28, 2024
Eng_Sotorasib_Guardant_PMDA_materials.pdf
11 MB
Feb 28, 2024

Sysmex Corporation (Onco Guide NCC oncopanel System)

Size
Published date
Eng_Futibatinib_Taiho_NCC_CDx_deliberation_result_report.pdf
3.3 MB
Feb 28, 2024
Eng_OncoGuide_Sample-preparation-guide.pdf
1.4 MB
Feb 28, 2024
OncoGuide-NCC-PMDA-Approval-document-translation.pdf
665.1 KB
Feb 28, 2024
qc_report_draft.pdf
103.9 KB
Feb 28, 2024
OncoGuide-NCC-PMDA-Approval-document.pdf
439.5 KB
Feb 28, 2024
qc_report_draft_JP_to_Eng.pdf
1 MB
Feb 28, 2024
sequencing_report_draft.pdf
2.7 MB
Feb 28, 2024
sequencing_report_draft_JP_to_Eng.pdf
3.5 MB
Feb 28, 2024
sequencing_report_draft_JP_to_Eng_full_translation.pdf
9.4 MB
Feb 28, 2024
summary_report_draft.pdf
1.5 MB
Feb 28, 2024
summary_report_draft_JP_to_Eng.pdf
324.6 KB
Feb 28, 2024

Size
Published date
Cost-Estimate_BostonGene_06052023.xls
36.5 KB
Feb 28, 2024
23-00930-01-1_MHLW-PMDA-Consultation_BostonGene_Cost-Estimate-_Jul--2023.pdf
479.9 KB
Feb 28, 2024
230905-BostonGene-CMIC-meeting-agenda.docx
16.1 KB
Feb 28, 2024
Billing-Invoice-8.10.23.pdf
1 MB
Feb 28, 2024
BostonGene-FS-report-Draft_06052023.docx
354.4 KB
Feb 28, 2024