Understanding Clinical Investigation and Clinical Performance Evaluation of Medical Devices & New IVDs

Focus on Chapter IV – Rule 49 to Rule 62 & Seventh Schedule (with reference to Rule 78E implications)

The Government of India has brought almost all medical devices and in-vitro diagnostics (IVDs) under the regulatory ambit of the Medical Devices Rules, 2017 (MDR). For any new or investigational medical device (including high-risk Class C & D devices) and all new in-vitro diagnostic medical devices that are not predicate or substantially equivalent, clinical evidence generated in India is mandatory before market authorization. This requirement is now explicitly stated under Rule 78E (inserted vide GSR 105(E) dated 11.02.2020 and further strengthened).

Below is a simplified yet comprehensive guide to the regulatory pathway for conducting clinical studies in India as of November 2025.

1. When is a Clinical Investigation / Clinical Performance Evaluation Required?

• Investigational medical device (any new non-predicate device or a device that is not substantially equivalent): Mandatory clinical investigation (pilot + pivotal) required unless waived in public interest by CDSCO.
• New in-vitro diagnostic medical device: Clinical performance evaluation is mandatory unless waived.
• Substantial equivalence route: If the device has the same intended use and either identical or different (but proven safe & effective) technological characteristics as a predicate device already approved in India, clinical investigation may be waived or abbreviated (Rule 51(5) & 59(4)).

2. Key Types of Studies

Government institutions/hospitals are completely exempt from fees.

3. Ethics Committee Requirements

The same Ethics Committee registered under Rule 122DD of Drugs & Cosmetics Rules (NDCT Rules) for drugs/clinical trials is automatically deemed registered for medical device studies (Rule 50). No separate registration is required.

4. Application Process & Timelines

Permission is granted in Form MD-23 (devices) or MD-25 (IVDs).

5. Mandatory Post-Approval Requirements

Once permission is granted, the sponsor MUST comply with the following (non-compliance can lead to suspension/cancellation):

1. Register the study on CTRI before enrolling the first participant.
2. Initiate the study within 1 year of permission (else fresh permission required).
3. Submit annual status report.
4. Report Suspected Unexpected Serious Adverse Events (SUSARs) within 14 calendar days.
5. Provide free medical management + compensation (as per Rule 122DAB of D&C Rules) in case of injury or death related to the investigational device/IVD.
6. Maintain records for 7 years after completion.
7. Sites open for CDSCO inspection at any time.

6. Compensation Rules (Same as BA/BE and Clinical Trials for Drugs)

• Injury → Complete medical management + financial compensation (quantum decided by EC/CDSCO as per 122DAB formula).
• Death related to device/IVD → Compensation to legal heir (fixed + variable component as per 122DAB).

7. Waiver/Abbreviation in Public Interest (Rule 51(4) & 59(4))

CDSCO can waive or abbreviate the requirement of:

• Pre-clinical (animal) data
• Pilot clinical data
• Full-scale pivotal study
• Clinical performance evaluation for IVDs

This is usually done for orphan devices, unmet medical needs, national emergencies, or when robust overseas clinical data already exists.

8. Implications of Rule 78E (as on 2025)

Rule 78E makes it mandatory for manufacturers/importers to submit India-specific clinical investigation or clinical performance evaluation reports (unless waived) while applying for manufacturing/import license for:

• All new medical devices (Class A, B, C, D that are not predicate)
• All new in-vitro diagnostics

Simply submitting foreign clinical data is no longer sufficient for high-risk or novel devices.

• Plan your India clinical strategy early — 90-day approval + 1-year initiation window means at least 15–18 months lead time.
• Budget for CTRI registration, EC fees, insurance/compensation, and CDSCO fees (except government institutions).
• Leverage the substantial equivalence pathway wherever possible to avoid or minimize local clinical studies.
• Always involve a registered Ethics Committee and follow GCP guidelines issued by CDSCO.

India is steadily aligning its medical device clinical trial regulations with global standards (ISO 14155, IMDRF guidance) while keeping patient safety and ethical principles at the core.

Stay compliant, stay ethical, and bring safer devices faster to Indian patients!