Permissions to Conduct Clinical Studies

CDSCO permissions to conduct clinical investigations of investigational medical devices and Performance Evaluation Reports for new IVDs. Requires an approved protocol, ethics-committee clearance from each participating site, registered investigators, and a clinical-trial insurance policy. Mandatory for any device claiming a unique indication or seeking pre-market clinical evidence in India. Approval timelines run 3–6 months and are tied to dossier completeness rather than the device class.

Get a Quote See 4 forms

Forms covered

4 CDSCO forms in this category

MD-22

Application for Grant of Permission to Conduct Clinical Investigation of Investigational Medical Device

Application for permission to conduct clinical investigation of investigational medical devices.

MD-23

Permission to Conduct Clinical Investigation

Permission granted to conduct clinical investigations on medical devices.

MD-24

Application for Grant of Permission to Conduct Clinical Performance Evaluation of New In Vitro Diagnostic Medical Devices

Application for permission to conduct clinical performance evaluations of new IVD devices.

MD-25

Permission to Conduct Clinical Performance Evaluation of New In Vitro Diagnostic Medical Devices

Permission granted for clinical performance evaluation of new IVD devices.

Code	Form name	Description
MD-22	Application for Grant of Permission to Conduct Clinical Investigation of Investigational Medical Device Application for permission to conduct clinical investigation of investigational medical devices.	Application for permission to conduct clinical investigation of investigational medical devices.
MD-23	Permission to Conduct Clinical Investigation Permission granted to conduct clinical investigations on medical devices.	Permission granted to conduct clinical investigations on medical devices.
MD-24	Application for Grant of Permission to Conduct Clinical Performance Evaluation of New In Vitro Diagnostic Medical Devices Application for permission to conduct clinical performance evaluations of new IVD devices.	Application for permission to conduct clinical performance evaluations of new IVD devices.
MD-25	Permission to Conduct Clinical Performance Evaluation of New In Vitro Diagnostic Medical Devices Permission granted for clinical performance evaluation of new IVD devices.	Permission granted for clinical performance evaluation of new IVD devices.

Eligibility

When you need these licences

Use this list to confirm whether this category applies to your device, role, or use case.

Investigational medical devices

For sponsors of clinical investigations on devices not yet commercially licensed in India.

New IVDs needing PER

For manufacturers of novel IVDs requiring clinical performance evaluation data.

Ethics committee approval

Investigations require approval from registered ethics committees at each site.

What's required

Documentation checklist

Clinical investigation plan / protocol
Investigator brochure
Informed consent forms
Case report forms
Statistical analysis plan
Site investigator credentials
Ethics committee submissions and approvals
Risk-benefit analysis
Insurance for trial participants

Process

Step by step

01
Protocol design
Endpoints, sample size, inclusion/exclusion criteria, statistical plan.
02
Ethics committee approvals
Submit to each site's ethics committee; obtain approvals.
03
MD-22 / MD-24 filing
Apply to CDSCO with protocol, IB, EC approvals, and supporting docs.
04
Technical review
CDSCO Medical Device Advisory Committee evaluates protocol and safety.
05
Permission grant (MD-23 / MD-25)
Permission issued with any specific conditions attached.
06
Study initiation
Investigator meetings, site initiation visits, study start-up.

How Bio-State helps

Clinical Studies & PER

End-to-end engagement covering forms in this category — from documentation to license in hand.

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FAQ

Common questions

Typically 12–16 weeks for clean submissions. Class C/D and novel-mechanism devices receive deeper review.

Yes — EC approvals must accompany the MD-22/MD-24 application. CDSCO will not review without them.

MD-22 is for medical device clinical investigations; MD-24 is specifically for IVD clinical performance evaluations.

Sometimes, with a bridging study. CDSCO requires Indian-population data for many high-risk devices.

Through serious adverse event reports (SAEs) to CDSCO within stipulated timelines, plus ongoing ethics committee notification.

Need help with clinical investigation permissions?

We'll send a fixed-fee quote and indicative timeline within 48 hours.

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