Can one technical dossier be used in multiple countries?
1 company with a published answer
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