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English — original official blank checklist

CDSCO public post-approval checklist — IVD category324 — Public checklist: change in the constitution of the authorised agent — IVD

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Contents

CHECKLIST Form Name: Post Approval Change Category: IVD Section no. Checklist Name Is Mandatory 1.0 Justification/Rationale for proposed changes Yes Upload existing Import License and its 2.0 No retention (if any) Copy of constitution details of the authorized 3.0 agent submitted at the time of grant of Yes license Copy of revised constitution details of the 4.0 Yes authorized agent 5.0 Other relevant document (if any) No 6.0 Application for PAC Yes

CDSCO public post-approval checklist — IVD category324 — official PDF page 1
CDSCO public post-approval checklist — IVD category324 — official PDF page 1