Featured Case Study
Import, Test & Manufacturing License for an IVD company
IVD Company India Regulatory Compliance
Challenge
An IVD company wanted to import diagnostics into India while establishing local manufacturing. Requirements for the Import, Test, and Manufacturing License under MDR 2017 were unclear, device classification and the approval pathway were difficult to determine, and the technical documentation and dossiers were incomplete. Gaps in the licensing approach were causing submission delays, compounded by a limited understanding of CDSCO processes.
Bio-State Solution
- Pathway & classification review
- Master files & documentation
- Test & Import License applications
- Manufacturing readiness & queries
Outcome
- Test License — approved
- Import License — obtained
- Manufacturing License — granted
- CDSCO submissions — compliant
Complete, compliant submissions that reduced approval timelines and enabled timely commercialization and market availability.
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