AEGIS
// LIFE SCIENCES
WORKBENCH/CASES/MEDTRONIC-ICM-001/04 SUBM
3 READY · 4 DRAFT · 0 FILED
sarah.chen@medtronic
STAGE 04 · SUBMISSION
7 dossiers ready for filing across APAC.
⬢ HERMES·dossier assembly & filing·CER 312pp · IFU locked · risk file v4
Filing authority: Sarah Chen (CRO)
HERMES has assembled and QC'd 7 jurisdiction-specific dossiers from the locked CER (312pp), IFU, risk file, PMCF plan, and value-claims pack. Each file is a separate irreversible action — Sarah is the only role authorized. Once filed, the review clock starts and the dossier cannot be retracted without a withdraw-and-refile cycle.
3Ready
4Draft
0Filed
✓
Completeness QC: all 7 dossiers contain every regulator-required section. Last scan 18 May · 09:14 UTC.
⚠
Consistency QC: 2 inconsistencies caught and fixed. Korean IFU — implantation procedure term mismatched KFDA preferred terminology · auto-corrected, awaiting Akira review. Australian site reference — clinical site not in original TGA ethics approval · removed from AU dossier.
READY
PMDA
JAPAN · ANCHOR
Dossier312pp + 84pp annex
FormatPMDA Class III
Review window~120 days
LanguageEN + JA exec
Completeness ✓
Consistency ✓
Predicate cited Reveal LINQ 2014
READY
HSA
SINGAPORE · RELIANCE
Dossier62pp reliance pack
FormatHSA-MDB-G009
Review window~35 days
AnchorPMDA (pending)
Reliance pack ✓
Sequence dep PMDA-after
DRAFT
NMPA
CHINA · LOCAL CT
Dossiertech file only
FormatNMPA 2021/01
StatusCT m4/18
Local CT running month 4
Full dossier q4 2026
FIX
TGA
AUSTRALIA · RELIANCE
Dossier58pp CO-OR
FormatTGA CO-OR scheme
Review window~50 days
AnchorPMDA (pending)
Site ref auto-removed
Akira review required
READY
KFDA
KOREA · HTA REVIEW
Dossier298pp + HTA annex
FormatMFDS 2024-58
Review window~168 days
TranslationKO IFU ✓
IFU re-translated auto-corrected
HTA evidence per-protocol only
DRAFT
TFDA
TAIWAN · RELIANCE
Dossier54pp draft
FormatTFDA-MD foreign
Review window~72 days
AnchorPMDA (pending)
Translation 60% complete
ETA 24 May
DRAFT
HK
HONG KONG · VRS
Dossier22pp summary
FormatMDD VRS
Review window~1 day
AnchorPMDA (pending)
Same-day listing
Filed last by design
LOCKED ARTIFACTSIFU · CER · risk file · value-claims pack5 artifacts · all sealed
▶
All downstream filings reference these locked source documents. No edits permitted after IFU lock without triggering a new sign-off cycle across all 7 dossiers.
CERv17 · 312 pages · locked 14 May · hash 9a4f...2c91
IFUEN master + 4 translations · locked 16 May · hash 7e22...0c14
Risk filev4 · 86 failure modes · locked 13 May · hash b811...3a92
PMCF planv3 · sealed 15 May · hash c44d...1108
Value-claims packFrom Stage 03 · hash a8b1...3c45
WORKFLOWHERMES's substages6 of 8 · week 5 of ~7
▶
W1
W2
W3
W4
W5
W6
W7
Source artifact lock
CER · IFU · risk file · VCP
DONE
7 dossier assembly
parallel reformat per regulator
DONE
Translation
JP · KO · ZH-CN · ZH-TW
LIVE
Completeness QC
HERMES · all sections present
DONE
Consistency QC
2 caught · 1 auto-fix · 1 pending
LIVE
Filing gate
Sarah Chen · 7 per-juris filings
GATE
Handoff to SENTINEL
per-juris as filed
PENDING
Case attributes
CaseMEDTRONIC-ICM-001
DeviceLINQ-NEXT · Class III ICM
RA LeadA. Tanaka · Tokyo
Filing authorityS. Chen · CRO · ONLY ROLE AUTHORIZED
Stage 03 received12 May · value-claims pack sealed
Reg bodies · filing details
PMDA · JPAnchor · Class III · 120d review
HSA · SGReliance on PMDA · 35d
NMPA · CNLocal CT m4/18 · file post-CT
TGA · AUCO-OR scheme · 50d
KFDA · KRFull HTA review · 168d
TFDA · TWForeign-approval pathway · 72d
HKMDD VRS · same-day
Trust + audit · stage 04 · 28 events
e91c...4d20HERMES · consistency QC · 2 inconsistencies caught18 May · 09:14
7e22...0c14IFU master + 4 translations locked16 May · 14:00
c44d...1108PMCF plan v3 sealed15 May · 11:30
9a4f...2c91CER v17 sealed · 312 pages14 May · 17:30
b811...3a92Risk file v4 sealed · 86 failure modes13 May · 16:10
a8b1...3c45Stage 03 value-claims pack received12 May · 17:00
Stage ThreadHERMES · FILING
04 SUBM · 28 events · 3 ready / 4 draft
HERMES18 May · 09:14
Consistency QC complete. 2 inconsistencies caught: Korean IFU implantation term mismatched MFDS preferred terminology (auto-corrected, awaiting Akira sign-off). Australian dossier referenced a clinical site not in original TGA ethics approval (site reference auto-removed). 3 dossiers READY for Sarah's filing: PMDA, HSA (post-PMDA), KFDA. 4 dossiers DRAFT.
e91c...4d20 · 2 ISSUES
HERMES16 May · 14:00
IFU lock complete. Master + 4 translations (JA, KO, ZH-CN, ZH-TW). Each translation cross-checked against master for claim consistency. No semantic drift detected. Sealed.
A. TANAKA · RA14 May · 16:00
Reviewed CER v17. Approving for lock. HERMES, start the 7-dossier assembly.
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Handoff packet · HERMES · 04 Submission → SENTINEL · 05 Authority Review
FROMHERMES · 04 Submission
TOSENTINEL · 05 Authority Review
RECEIPT7f3b…91d4
DOSSIER312pp + 84pp annex · PMDA Class III format
SUBMITTED TOPMDA · Tokyo · 17 May 14:22 KST
EXAMINER ASSIGNMENTDr. Y. Watanabe (PMB/SD No.1228 pathway)
REVIEW WINDOW120 days · clock starts 18 May 09:00 JST
CER LOCKEDv17 · 312 pages
IFU LOCKEDEN + JA executable · all 7 jurisdictions
RISK FILEv4 · ISO 14971 aligned
PMCF PLAN3-yr · 455 patients · WHO 2024 reference cohort
RELIANCE QUEUEHSA · TGA · TFDA · HK awaiting PMDA milestone