Can one technical dossier be used in multiple countries?

1 company with a published answer

  1. Pure Global

    “A controlled core dossier can usually supply much of the same device description, design, risk, verification, clinical, software, labeling, and quality evidence across markets. It is not a universal submission.”

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Data formats and record details
Surface ID
urn:readyscan:corpus:buyer-question:pure-global-q136308885-answer-b8eb621329c25e997ddd
Material fingerprint
fnv1a64:820be68a9d686058
Membership fingerprint
fnv1a64:8a1849c73c1d3cab
Published
2026-10-28
Modified
2026-10-28
ready-scan-subjects/Q136308885
revision Q136308885:content:3e9a0682a149553c

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