What is MD-25?
Permission in Form MD-25 is an authorization granted by the Central Licensing Authority (CDSCO) to conduct clinical performance evaluation studies of new in vitro diagnostic (IVD) devices in India.
This approval is required to conduct clinical performance evaluation studies for new IVDs to generate clinical evidence demonstrating the safety, performance, and intended use of the device under actual or simulated conditions.
MD-25 plays a critical role in product approval, as clinical performance data is often a key requirement for regulatory registration. Without this permission, conducting such studies in India is not allowed.
When Do You Need MD-25 Permission?
Support for clinical performance evaluation of new IVDs in India, including study design, documentation, and regulatory coordination.
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Conducting clinical performance evaluation of a new IVD in India
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Generating Indian clinical performance data for regulatory approval
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Validating diagnostic sensitivity, specificity, accuracy, or clinical performance
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Conducting studies involving human samples or patient data
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Supporting approval of new Class B, C, or D IVDs, where required by CDSCO.
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Designing a compliant clinical performance study protocol
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Aligning with CDSCO and ethical committee requirements
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Selecting qualified clinical sites and investigators
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Preparing complete technical and clinical documentation
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Handling regulatory queries and review timelines
Our Approach and What You Will Get
Structured support for regulatory assessment, study planning, documentation, CDSCO coordination, and post-approval guidance.
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Regulatory assessment and study strategy
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Clinical Performance Evaluation Plan (CPEP) support
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Documentation preparation
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MD-24 application filing
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CDSCO coordination and query management
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Post-approval regulatory guidance.
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MD-24 application preparation & filing
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Clinical Performance Evaluation Plan (CPEP) support
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Study protocol development
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Investigational plan documentation
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Risk management documentation support
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Ethics Committee documentation guidance
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CDSCO submission support
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Query response assistance
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Post-approval compliance guidance
Why Choose Tacit Medtek and Case Example
Strong support for CDSCO submissions, compliant study design, and end-to-end guidance for IVD clinical performance evaluation in India.
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Strong expertise in IVD clinical and regulatory pathways
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Hands-on experience with CDSCO submissions
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Focus on scientifically sound and compliant study design
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Reduced approval timelines through structured documentation
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End-to-end support from planning to approval
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Challenge: A diagnostics company needed Indian clinical data for a novel biomarker-based IVD but lacked a compliant study design and regulatory clarity.
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Our Approach: We developed a detailed clinical performance protocol, aligned documentation with CDSCO requirements, and supported ethics approvals and submission.
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Outcome: The client received MD-25 approval and successfully completed the clinical performance evaluation and generated the clinical evidence required for regulatory approval.
FAQ
Frequently Asked Questions
Clinical performance data such as sensitivity, specificity, and accuracy.
Yes, approval from a registered Ethics Committee is required before initiating the study.
Yes. Clinical performance evaluation studies may be conducted at multiple approved clinical sites in India, subject to CDSCO and Ethics Committee approvals.
No. MD-25 is generally required for new IVDs where CDSCO mandates clinical performance evaluation before approval.
Not necessarily. CDSCO may require clinical performance evaluation to be conducted in India depending on the type, intended use, and risk class of the IVD.
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