What is Permission to Manufacture
New IVDs (MD 29)
Permission in Form MD-29 is issued under the Medical Devices Rules, 2017 for manufacturing new IVDs intended for clinical investigation or clinical performance evaluation in India.
The permission is granted by the Central Licensing Authority (CDSCO) and allows manufacturers to legally manufacture investigational quantities of devices for approved clinical studies and performance evaluation purposes.
Obtaining MD-29 approval is essential before manufacturing investigational IVD devices for generating clinical evidence required for future regulatory approvals in India.
When Do You Need Investigational IVD Support?
Support for investigational IVD manufacturing, clinical performance studies, and documentation for CDSCO-aligned approvals in India.
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Producing experimental IVD devices for assessing clinical performance
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Producing devices for approved clinical investigation studies
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Generating clinical evidence for new IVD approvals
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Manufacturing pilot batches for investigational use only
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Conducting studies for new Class C & D IVD devices
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Supporting future manufacturing or import approvals.
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Determining investigational device applicability
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Preparation of technical and study documentation
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Compliance with CDSCO clinical investigation requirements
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Ethics Committee coordination
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Manufacturing control for investigational batches
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Labeling compliance for investigational use
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CDSCO query and review management
Our Approach and What You Will Get
Structured support for regulatory assessment, documentation preparation, compliance review, and CDSCO submission management.
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Regulatory assessment
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Documentation preparation
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Compliance & technical support
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CDSCO submission management
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MD-28 application preparation
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Technical dossier support
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Investigational labeling review
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CDSCO submission support
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Query response assistance
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Regulatory coordination support
Why Choose Tacit Medtek and Case Example
End-to-end support for IVD clinical and regulatory pathways, CDSCO approvals, and investigational manufacturing for clinical evaluation studies.
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Expertise in IVD clinical and regulatory pathways
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Strong understanding of CDSCO approval pathways
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End-to-end documentation and submission support
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Efficient regulatory coordination and submission management
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Challenge: A diagnostics startup developed a new Class D molecular assay for tuberculosis detection and required approval to manufacture investigational batches for clinical performance studies.
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Our Approach: Tacit Medtek prepared the MD-28 application dossier, reviewed investigational labelling, and coordinated CDSCO submissions.
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Outcome: The client successfully obtained MD-29 permission and initiated investigational manufacturing for clinical evaluation studies.
FAQ
Frequently Asked Questions
MD-29 is permission granted by CDSCO for manufacturing investigational new IVDs for clinical investigation or performance evaluation purposes.
No. Devices manufactured under MD-29 are strictly for investigational or clinical evaluation purposes and cannot be commercially distributed.
Yes. Separate regulatory evaluation and approval may be required for each new investigational IVD device.
Yes. Imported raw materials and components may be used subject to applicable regulatory and import compliance requirements.
No. Manufacturing and use of investigational IVD devices for studies should begin only after obtaining applicable CDSCO permission and Ethics Committee approval.
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