What is Permission to Import
Investigational Medical Devices
MD 27
Permission to Import Investigational Medical Devices in Form MD-27 is granted by CDSCO under the Medical Devices Rules, 2017 for importing investigational medical devices into India for clinical investigation, performance evaluation, testing, or related non-commercial purposes. The application is submitted through Form MD-26 by the importer or authorized agent. This permission is applicable for investigational devices that are not yet commercially approved in India and are intended only for approved clinical or evaluation activities. MD-27 helps ensure regulatory compliance, patient safety, ethical oversight, and proper control over investigational medical device imports in India.
When Do You Need Clinical Investigation Import Support?
Support for importing investigational medical devices, managing approvals, and preparing for clinical investigation or performance evaluation in India.
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Importing investigational medical devices for clinical investigation in India
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Importing devices for clinical performance evaluation or testing
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Conducting approved investigational studies before commercial approval
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Generating clinical or performance data for regulatory submissions
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Importing devices for Ethics Committee-approved clinical investigations
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Extensive CDSCO documentation requirements
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Coordination of clinical investigation and import approvals
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Ethics Committee approval management
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Technical documentation and investigational data gaps
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Regulatory queries and review timelines
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Compliance with investigational labelling and usage requirements
Our Approach and What You Will Get
End-to-end support for investigational medical device approvals, documentation, ethics coordination, and CDSCO submission.
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Device classification and regulatory pathway assessment
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Preparation of MD-26 application dossier under MDR 2017
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Clinical Investigation Plan and supporting document review
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Ethics Committee coordination and compliance requirements support
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Technical documentation and risk management review
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CDSCO submission and regulatory coordination
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Query response support until approval
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End-to-end support for MD-26 and MD-27 applications
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Accurate and compliant regulatory documentation support
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Assistance with CDSCO coordination and query management
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Support for Ethics Committee documentation and compliance
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Regulatory guidance throughout investigational device approval activities
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Long-term compliance support for importers and manufacturers
Why Choose Tacit Medtek and Case Example
Strategic support for investigational device approvals, CDSCO coordination, and compliant clinical study imports in India.
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Deep knowledge of CDSCO medical device rules
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All your regulatory needs covered in one place
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Strategic documentation planning to support efficient regulatory review.
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Submissions that are accurate, complete, and audit-ready
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Dedicated help from experienced regulatory pros
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Guidance at every step of the approval journey
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Clear, precise, and fully compliant execution
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Extensive experience with investigational device approvals
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Efficient handling of complex regulatory requirements
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Long-term compliance support for manufacturers and importers in India
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Challenge: A global medical device manufacturer needed to import investigational devices into India for a multi-site clinical study but faced delays due to incomplete documentation and lack of clarity on regulatory linkage between import permission and clinical investigation approval under CDSCO.
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Our Approach:
- Reviewed clinical investigation requirements and aligned the import strategy.
- Confirmed device classification and MD-27 eligibility.
- Prepared key documents: clinical protocol, Investigator’s Brochure, risk analysis file.
- Ensured proper labelling: “For Clinical Investigation Use Only – Not for Sale”.
- Submitted MD-27 application and supported CDSCO query resolution during regulatory review.
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Outcome: The client successfully obtained MD-27 permission after successful completion of CDSCO review and regulatory requirements.
FAQ
Frequently Asked Questions
Applications for import or manufacture of investigational medical devices are submitted in Form MD-26, and permission is granted in Form MD-27 under MDR 2017.
For investigational devices without predicate devices, CDSCO may require additional technical, safety, performance, clinical, and risk assessment documentation as per applicable MDR 2017 requirements.
PSUR submission frequency, where applicable, is based on conditions specified by CDSCO and the regulatory requirements applicable to the investigational device approval.
Medical device classification applicable in India is determined as per MDR 2017 classification requirements and CDSCO regulatory assessment.
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