Permission to Conduct Clinical Investigation of Medical Devices (Form MD 23)
Permission to Conduct Clinical Investigation (Form MD-23) is granted by CDSCO under the Medical Devices Rules, 2017 for conducting clinical investigations of investigational medical devices in India. The application is submitted through Form MD-22 and is required to evaluate the safety, performance, and clinical effectiveness of a device in human participants before regulatory approval.This permission supports compliance with applicable ethical, clinical, and regulatory requirements while enabling lawful conduct of clinical investigations in India.
When Do You Need Clinical Data Support
and What Are the Key Challenges?
Support for medical devices that need human clinical evidence, investigation planning, and CDSCO-ready documentation under MDR 2017.
-
When clinical data is required to evaluate the safety and performance of a medical device
-
For investigational or novel medical devices without sufficient existing clinical evidence
-
When substantial equivalence to an approved device cannot be established
-
Prior to initiating clinical investigation activities in India
-
When CDSCO requires human clinical data for regulatory approval
-
To generate clinical evidence supporting manufacturing or import applications
-
Regulatory Documentation Complexity
-
Trial Site and Investigator Identification
-
Ethics Committee Approval Timelines
-
Demonstrating Safety and Performance of Novel Devices
-
CDSCO Query Management
-
Ongoing Compliance During Investigation
Our Approach and What You Will Get
End-to-end support for clinical investigation planning, ethics coordination, regulatory submissions, and post-permission compliance.
-
Device and Clinical Assessment
-
Clinical Investigation Plan (CIP) Development
-
Ethics Committee and Regulatory Coordination
-
MD-22 Application Preparation and Submission
-
Query Management and Approval Support
-
Post-Permission Compliance Support
-
Complete support for MD-22 and MD-23 filings
-
Paperwork that’s accurate, compliant, and audit-ready
-
A clear regulatory plan made just for your device
-
Efficient regulatory management and support for a smoother approval process
-
Smooth coordination with trial sites and ethics committees
-
End-to-end help—from planning to final approval
-
Fewer delays, rejections, and compliance headaches
Why Choose Tacit Medtek and Case Example
End-to-end support for CDSCO clinical investigation requirements, documentation, ethics coordination, and post-permission compliance.
-
Specialist expertise in CDSCO clinical investigation requirements under MDR 2017, including MD-22 application preparation and CIP development
-
Established coordination experience with institutional Ethics Committees across multiple clinical investigation sites in India
-
End-to-end clinical documentation capability — from Investigator's Brochure to informed consent templates and adverse event reporting frameworks
-
Proven query management track record with CDSCO clinical investigation review teams
-
Integrated regulatory strategy — positioning the clinical investigation as part of the broader manufacturing or import license pathway
-
Post-permission compliance support throughout the active investigation period
-
Challenge: A medical device company planned to conduct a clinical investigation for a new device in India but faced uncertainty regarding regulatory requirements, approval timelines, and documentation needed for CDSCO permission. They also struggled with preparing a compliant clinical investigation plan and coordinating with investigators.
-
Our Approach: Assessed the device classification and clinical investigation requirements under MDR, 2017. Prepared a comprehensive Clinical Investigation Plan (CIP) along with Investigator’s Brochure and supporting documents. Ensured compliance with ethical requirements, including Ethics Committee approvals and informed consent documentation. Compiled and submitted a complete MD-23 application to CDSCO. Coordinated with stakeholders and addressed queries raised during the review process.
-
Outcome: The client successfully obtained MD-23 permission after completion of regulatory review and required approvals, enabling them to initiate the clinical investigation in compliance with Indian regulatory requirements.
FAQ
Frequently Asked Questions
Yes. Sponsors or applicants are generally required to obtain prior approval from the Central Licensing Authority before initiating clinical investigation activities involving investigational medical devices in human participants.
A Clinical Investigation Plan generally includes study objectives, methodology, participant criteria, safety monitoring procedures, statistical considerations, and ethical compliance details in accordance with applicable MDR 2017 requirements.
A Clinical Investigation Report typically summarizes study conduct, participant data, safety observations, performance outcomes, deviations, and overall conclusions generated during the clinical investigation process.
Enquire Now
Fill in the form and our team will get back to you shortly.
Reach our regulatory experts directly.