What is MD-29?
Permission in Form MD-29 is an approval granted by the Central Licensing Authority (CDSCO) to import new in vitro diagnostic (IVD) devices into India.
A "new IVD" refers to an in vitro diagnostic device that has not been previously approved by CDSCO for the proposed intended use in India. This permission is essential to establish the safety, performance, and regulatory acceptability of the product before it enters the Indian market.
MD-29 acts as a critical regulatory checkpoint, ensuring that only validated and compliant IVDs are introduced for further evaluation or registration.
When Do You Need MD-29 Permission?
Support for importing a new IVD into India, preparing technical documentation, and managing CDSCO review and approvals.
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You plan to import an IVD not yet approved in India.
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Your product falls under the “new IVD” category as per CDSCO.
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You require approval before registration or clinical evaluation.
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You are introducing innovative or first-in-market diagnostic technology.
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Determining whether your product qualifies as a “new IVD”
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Preparing a complete technical dossier aligned with CDSCO expectations
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Addressing regulatory gaps between global approvals and Indian requirements
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Managing documentation such as Free Sale Certificates and performance data
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Handling authority queries and long review timelines
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Coordinating between manufacturer and Indian authorized agent
Our Approach and What You Will Get
Structured support for regulatory assessment, dossier preparation, CDSCO submission, and post-approval guidance for new IVD applications.
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Regulatory assessment and classification
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Gap analysis and documentation preparation
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MD-28 application preparation & filing
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CDSCO submission and query management
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Coordination with the manufacturer and Indian Authorized Agent
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Post-approval regulatory guidance
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Regulatory pathway assessment
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Gap analysis report
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Technical dossier review and compilation
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MD-28 application preparation & filing
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Cover letter and justification documents
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End-to-end submission support
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Query response management
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Post-approval compliance guidance
Why Choose Tacit Medtek and Case Example
In-depth support for CDSCO import regulations, new IVD approvals, documentation strategy, and alignment with Indian regulatory requirements.
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In-depth expertise in CDSCO import regulations
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Experience with new and innovative IVD approvals
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Strong documentation and review strategy
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Reduced approval timelines through structured submissions
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Dedicated support for both Indian agents and global manufacturers
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Expert guidance in aligning global technical documentation with Indian regulatory requirements.
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Challenge: An international manufacturer based in China planned to introduce a novel molecular diagnostic IVD in India but faced uncertainty regarding “new IVD” classification and documentation gaps.
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Our Approach: We conducted a regulatory assessment, aligned global data with Indian requirements, prepared the dossier, and managed submission and queries.
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Outcome: The client successfully obtained MD-29 permission and proceeded with the subsequent regulatory approval process in India.
FAQ
Frequently Asked Questions
No. MD-29 is generally required only for “new IVDs” that have not been previously approved in India.
Yes. CDSCO may require Indian clinical performance evaluation data for certain new or higher-risk IVDs before approval.
Yes. As per CDSCO notification No. IMPORT/Misc/2015-DC dated 01.12.2015, IVDs with less than 60% residual shelf life may be imported under an MD-17 Test License for testing, demonstration, or training purposes.
Yes. Free Sale Certificate and other regulatory approvals from the country of origin are generally required as part of the submission dossier.
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