Three practical checklists our consultants use every week, free for medical device and IVD manufacturers, importers and distributors. Tick them off before you file and avoid the gaps that cause CDSCO queries, notified body findings and FDA Additional Information requests.
What you get
CDSCO Medical Device Registration Checklist 2026
Classification, the right licence (MD-5, MD-9, MD-15, MD-13/17, MD-42), Device and Plant Master File items, import documents and post-licence duties.
EU MDR CE Marking Technical Documentation Checklist
Annex II and Annex III item by item: GSPR, risk management, verification and validation, clinical evaluation, PMS, PMCF and PSUR.
US FDA 510(k) Readiness Checklist (FY2027)
Pathway and predicate, eSTAR contents, testing, FY2027 user fees, establishment registration, US Agent and QMSR duties.
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