What is Permission to Conduct Clinical
Performance Evaluation
of New IVDs (MD 25)
Permission to Conduct Clinical Performance Evaluation of New In-vitro Diagnostics (IVDs), granted via Form MD-25, is the official approval from the Central Licensing Authority (CLA) in India (CDSCO) to evaluate the safety and efficacy of new diagnostics.
This regulatory step is mandatory for new IVDs lacking a predicate device before they can be officially imported or manufactured.
When Do You Need New IVD Support?
Support for introducing a new IVD in India when predicate device data is unavailable and clinical performance evidence is required.
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Introducing a New IVD
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Absence of predicate device data in India
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Determining whether the IVD qualifies as a “new IVD”
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Preparation of Clinical Performance Evaluation Plan (CPEP)
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Ethics Committee coordination
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Selection of approved study sites
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Technical dossier and regulatory documentation preparation
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CDSCO query management
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Compliance with Good Clinical Practices (GCP)
Our Approach and What You Will Get
Structured support for regulatory assessment, documentation, application filing, and authority coordination for clinical performance evaluation activities.
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Regulatory assessment
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Documentation preparation
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Application filing
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Authority coordination
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NSWS registration support
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MD-22 application preparation & filing
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Clinical Performance Evaluation Plan (CPEP) support
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Investigator’s Brochure review
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Technical documentation support
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Ethics Committee documentation guidance
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CDSCO submission support
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Query response assistance
Why Choose Tacit Medtek and Case Example
End-to-end support for IVD clinical and regulatory pathways, including CDSCO clinical evaluation requirements, documentation, and submissions.
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Expertise in IVD clinical and regulatory pathways
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Strong understanding of CDSCO clinical evaluation requirements
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End-to-end documentation and submission support
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Experience with IVD performance studies
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Compliance-focused regulatory approach
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Challenge: A manufacturer developed a new Class D multiplex PCR assay for simultaneous detection of respiratory pathogens and required CDSCO approval for clinical performance evaluation in India.
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Our Approach: Tacit Medtek prepared the MD-22 application, supported protocol and CPEP documentation, and coordinated with study sites and Ethics Committees.
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Outcome: The client obtained MD-25 permission successfully and initiated multicentric clinical performance evaluation studies in India.
FAQ
Frequently Asked Questions
No, Form MD-25 is not mandatory for all IVD devices in India. It is only required for approval to undertake a Clinical Performance Evaluation of a "New" In Vitro Diagnostic (IVD) kit.
No. The Clinical Performance Evaluation may not be necessary, the Central Licensing Authority deems it is necessary depending on the type of the IVD.
No. Clinical Outcomes Regardless of their regulatory status in these nations, evaluation must be done in India before new IVDs can be approved.
Yes. Approval from a registered Ethics Committee is required before initiation of the study.
A new IVD includes a device that has not been approved previously in India by CDSCO for the proposed intended use.
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