categories:

• Class A – Low risk (e.g., tongue depressors)
• Class B – Low-moderate risk (e.g., hypodermic needles)
• Class C – Moderate-high risk (e.g., ventilators)
• Class D – High risk (e.g., implantable pacemakers)

Clinical investigations are mandatory for Class C and D devices if they are new to India and lack approval in other major regulatory jurisdictions (US FDA, CE, TGA, etc.).

Core Clinical Trial Insights

When is a Device Clinical Trial Required?

Device trials in India are required under the following scenarios:

• First-in-human testing of new medical devices.
• Devices that have not been marketed in India and lack foreign regulatory approval.
• Substantial modifications to an approved device’s design, materials, or intended use.
• Combination products (device + drug) where the device acts as the primary mode of action.

Clinical Investigation Protocol Approval

Approval from the CDSCO is required before initiating a clinical investigation for Class C or D investigational devices. The application must include:

• Clinical investigation protocol
• Investigator’s brochure
• Device master file
• Risk analysis report
• Informed Consent Documents (ICD)
• Pre-clinical or bench testing data
• Ethics Committee (EC) approval

Form MD-22 is used to apply for permission to conduct a device clinical investigation.

Approval Timeline and Review Process

The CDSCO typically reviews device clinical trial applications within 90 working days. However, in priority sectors or public health emergencies, timelines may be shortened. The Drugs Controller General of India (DCGI) grants the permission via Form MD-23.

Clinical Investigation Phases and Study Design

Unlike drugs, devices may undergo fewer “phases,” but follow a staged validation approach:

• Pilot/Feasibility Studies: Limited subjects to validate safety and technical performance.
• Pivotal Studies: Larger sample sizes to confirm efficacy, typically multicentric.
• Post-market Clinical Follow-up (PMCF): Required under PMS conditions for novel or implantable devices.

ISO 14155:2020 is the globally accepted GCP equivalent for device clinical investigations.

Trial Site and Investigator Requirements

Investigational device trials can be conducted at government or private hospitals with:

• Facilities to handle the target disease and use the device safely.
• Investigators trained in GCP and device operation.
• Ethics Committees registered with CDSCO.

Sites must be equipped to monitor adverse device effects (ADEs) and submit prompt reports.

Import Requirements for Investigational Devices

Devices not manufactured in India require an Import License via Form MD-20. These licenses are specific to the device, batch, and intended use for trials only. No commercial sale is permitted until approval.

Informed Consent and Ethics Committee Oversight

Informed consent for device trials must follow CDSCO and ICMR guidelines. For high-risk devices, additional safeguards like video recording or third-party witnesses may be mandated. ECs must review:

• Protocol and risk disclosures
• Investigator qualifications
• Compensation plans for trial-related injury

Reporting Requirements and Form MD-24

Upon trial completion, sponsors must submit the final report using Form MD-24. This includes:

• Clinical investigation outcomes
• Statistical analysis of safety and effectiveness
• Device-related adverse events and actions taken
• Protocol deviations and corrective measures

Post-Market Surveillance and Vigilance

Approved devices, especially Class C and D, are subject to PMS obligations. These include:

• Periodic safety reports
• Device Vigilance Reports (DVRs)
• Field safety corrective actions (FSCAs)
• Recall mechanisms

Indian Pharmacopoeia Commission (IPC) manages the Materiovigilance Program of India (MvPI), which coordinates device-related safety data from hospitals and users.

Best Practices & Preventive Measures

• Engage early with CDSCO for clarification on device classification and trial obligations.
• Pre-validate protocols with key investigators to ensure technical feasibility.
• Choose sites with device-handling capabilities and prior trial experience.
• Ensure ethics documentation is fully aligned with ISO 14155 and ICMR requirements.
• Maintain robust device tracking and calibration records throughout the trial.

Scientific & Regulatory Evidence

• Medical Devices Rules, 2017: Schedule VIII, Rule 63–73 for clinical investigations.
• GSR 78(E), 2020: Reclassification and device listing updates.
• CDSCO Forms MD-22 to MD-24: For permission, approval, and trial completion.
• ISO 14155:2020: GCP-equivalent for clinical investigations of medical devices.
• Materiovigilance Program of India (MvPI): Safety monitoring of approved devices.

Special Considerations

Combination Products

For device-drug combinations, the regulatory path depends on the primary mode of action. If the device component dominates, CDSCO routes the application under MDR; otherwise, NDCTR provisions apply.

Diagnostics and Software as Medical Device (SaMD)

Clinical trials for SaMDs are still evolving. Currently, pilot testing and retrospective validations in hospital settings are acceptable substitutes for traditional trials.

Digital Devices and Wearables

Wearables intended for medical diagnosis (e.g., ECG patches) must undergo CDSCO scrutiny and may require clinical performance evaluations. ECs often scrutinize privacy safeguards for such digital endpoints.

When Sponsors Should Seek Regulatory Advice

• To determine device classification before trial planning
• When designing first-in-human studies for Class C/D devices
• If planning adaptive or single-arm pivotal studies
• To clarify combination product regulation pathway
• When submitting import applications for non-Indian devices

FAQs

1. Are clinical trials mandatory for all medical devices in India?

No. Trials are mandatory for Class C and D investigational devices without prior approval in regulated markets. For Class A and B, trials are rarely required.

2. How long does it take to get CDSCO approval for a device clinical trial?

The review timeline is typically 90 working days post-submission of Form MD-22 with complete documentation.

3. Is EC approval needed before applying to CDSCO?

Yes. Ethics Committee approval is a prerequisite for applying to CDSCO for clinical investigation permission.

4. Can foreign companies conduct device trials in India?

Yes, through Indian subsidiaries or authorized CROs. Import licenses are needed for investigational use.

5. What guidelines govern ethics in device studies?

ISO 14155:2020 and ICMR guidelines for clinical research ethics are applicable, along with CDSCO requirements.

6. How is device safety monitored post-trial?

Via the Materiovigilance Program of India (MvPI), which requires reporting of adverse device events and corrective actions.

Conclusion

India’s medical device regulatory landscape is maturing, with defined provisions for clinical trials, ethics oversight, and post-market vigilance. Sponsors must navigate a separate pathway under the MDR 2017, distinct from drug trials governed by NDCTR. With increasing demand for device innovation and localization, India offers opportunities for early-phase device research backed by regulatory clarity, structured processes, and global harmonization. Proactive engagement with CDSCO and adherence to ISO 14155 can ensure compliance and trial success.