Import, Test & Manufacturing License for an IVD company
An IVD company planning to import diagnostics into India while establishing local manufacturing secured its licenses through complete, compliant submissions.
Industry
Medical devices / IVD
Location
India
Services
Regulatory Compliance
Category
Regulatory Approvals
Regulatory ApprovalsAn 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.
IVD Company
Client Type
Medical devices / IVD
Product Category
India
Target Market
Challenges Faced
- Unclear regulatory requirements for Import, Test, and Manufacturing License under MDR 2017.
- Difficulty determining the correct device classification and approval pathway.
- Incomplete technical documentation and regulatory dossiers.
- Delays in submission due to gaps in licensing requirements and supporting documents.
- Limited understanding of CDSCO application processes and regulatory expectations.
Our Approach
- Conducted a regulatory pathway assessment and device classification review to confirm the correct approval route.
- Prepared and reviewed the Device Master File (DMF), Plant Master File (PMF), and supporting documents.
- Filed Test License applications for product evaluation and the Import License application with CDSCO portal submissions.
- Guided Manufacturing License requirements, facility readiness, and documentation compliance; reviewed labeling, IFU, and regulatory declarations; and managed CDSCO query responses and authority coordination.
A clear path, milestone by milestone
Pathway & classification review
Master files & documentation
Test & Import License applications
Manufacturing readiness & queries
What it meant for the client
Test License successfully approved for product evaluation activities.
Import License obtained without major regulatory deficiencies.
Manufacturing License granted following successful regulatory review.
Reduced approval timelines through complete and compliant submissions.
Enabled timely commercialization and market availability of the products.
Key Results
Approved
Test License
Obtained
Import License
Granted
Manufacturing License
Compliant
CDSCO submissions
Every engagement is led by senior regulatory experts — with transparent milestones, complete documentation, and fixed-scope clarity from day one.
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