How to Apply for CDSCO Medical Device Clinical Investigation Approval in 2026?

To perform a clinical investigation in India, securing permission from the CDSCO is non-negotiable. A detailed study protocol has to be developed keeping patient safety in mind. The clinical investigation plan should comply with the ethical principles and applicable CDSCO regulatory guidelines. We have prepared a detailed guide on how to apply for CDSCO medical device clinical investigation approval in 2026.

What is medical device clinical investigation?

A medical device clinical investigation is a systematic structured study in human subjects designed to evaluate the safety, performance, and effectiveness of a medical device before or after market approval. The purpose is to generate clinical evidence proving that a device performs as intended and is safe for patient use. In India, medical device clinical investigation must be registered with the Clinical Trial Registry of India (CTRI) and follow CDSCO’s Good Clinical Practice guidelines. Additionally, these studies require approval from ethics committees to protect participants. They typically involve protocols that define objectives, methodology, risk management, and monitoring procedures to ensure scientific validity and patient safety. Thus, clinical investigations serve as the bridge between device innovation and safe, effective patient care, thereby ensuring that new technologies meet both medical and regulatory expectations.

CDSCO medical device clinical investigation

CDSCO license for medical device clinical investigation

The CDSCO license to conduct medical device clinical investigation is Form MD 23. Any medical device manufacturer/importer who wants to conduct a clinical investigation in India must apply online to the CLA. The application for conducting clinical investigation has to be submitted under Form MD-22. The license to conduct clinical investigations for medical devices in India will be granted under CDSCO Form MD-23.

Essential documents required to get CDSCO medical device clinical investigation license

We have provided an overview of the documents required to secure the CDSCO medical device clinical investigation license.

1. Clinical investigation plan
2. Ethics committee approval letter
3. Design input and output documents
4. Mechanical and electrical tests (if any)
5. Reliability tests
6. IFU and labels
7. Biocompatibility test reports

We have provided an overview of the documents required while applying for the license to conduct clinical investigation in India. For a detailed checklist of documents required, feel free to contact us. Additionally, we provide document preparation service. We will prepare and collate all the documents required as per CDSCO guidelines.

Criteria for conducting clinical investigation in India

CDSCO has laid down certain conditions for conducting medical device clinical investigation in India. Additionally, the CLA may impose certain additional conditions when granting permission for a particular clinical investigation. The CLA may impose restrictions on the study objective, design, population, eligibility criteria, assessment protocol, etc. Thus, the particular research group will have to comply with the additional conditions along with the general conditions listed below.

• The investigation study can start only after the registered Ethics Committee approves the clinical investigation plan.
• The clinical investigation has to be performed according to the pre-approved clinical investigation plan and Good Clinical Practices Guidelines.
• The clinical investigation study must be registered with the clinical trial registry of India prior to registering the first study participant.
• Within a year of receiving the permission from the regulatory body, the clinical investigation research group is required to enrol the first participant.
• The CLA officials may inspect the sponsor’s facilities, including employees, subsidiaries, branches, agents, contractors, and clinical investigation sites. They will carry out the inspection to ensure compliance with regulatory guidelines for conducting CDSCO medical device clinical investigation in India.
• The sponsor is required to submit a yearly report mentioning the investigation’s status to the CLA. If the investigation is terminated, the CLA must be intimated with the reasons for the termination within 30 days.
• The applicant is required to provide complete medical management or compensation if any subject is injured or dies during the clinical investigation.
• Within 14 days of occurrence of an unexpected serious adverse event during the clinical investigation, the sponsor is required to inform the CLA.

How to apply for CDSCO medical device clinical investigation license?

We have provided an overview of the application process for obtaining the CDSCO medical device clinical investigation license.

1. The application should be addressed to the CLA and CDSCO.
2. The application has to be filed under Form MD-22.
3. The application for conducting clinical investigation along with the required fees and relevant documents have to be submitted to the official CDSCO online license application portal, SUGAM.
4. The application will be reviewed and verified by the regulatory officials.
5. Only if everything is in order, the permission to conduct the clinical investigation in India will be granted. The license is granted under Form MD-23 by the regulatory officials. However, if the CLA feels the application does not comply with the regulations, it will reject the application.

Validity of the CDSCO medical device clinical investigation license

Unless suspended or cancelled, the CDSCO medical device clinical investigation license (Form MD-23) will remain valid. If the applicant or the clinical registration process fails to comply with the CDSCO regulatory guidelines, the Form MD-23 license will be cancelled.

5‑step preparation guide for CDSCO medical device clinical investigation approval

We have provided a step-by-step detailed preparation guide for applying for medical device clinical investigation approval.

1. Draft clinical investigation plan: Prepare a detailed Clinical Investigation Plan (CIP) outlining objectives, methodology, endpoints, and risk management. Ensure alignment with ISO 14155:2026 and CDSCO GCP guidelines. Include provisions for ethics committee review and subject safety. This document forms the backbone of your submission.
2. Secure ethics committee approval: Submit the CIP and supporting documents to an Institutional Ethics Committee for review. Approval is mandatory before initiating any human subject study. Provide informed consent forms and patient information sheets. Ethics clearance demonstrates compliance with ethical standards.
3. Compile regulatory dossier: Prepare a dossier including device details, preclinical data, investigator brochures, and manufacturing information. Ensure all documents meet CDSCO’s format and submission requirements. Include adverse event reporting procedures and monitoring plans. This dossier is submitted to CDSCO for review.
4. Register with Clinical Trial Registry of India (CTRI): Register the clinical investigation with the Clinical Trial Registry of India (CTRI). Public registration ensures transparency and accountability. Provide trial identifiers, sponsor details, and study design information. CTRI registration is a prerequisite for CDSCO approval.
5. Submit application to CDSCO: File the complete application through CDSCO’s online portal, including CIP, ethics approval, dossier, and CTRI registration. Pay applicable fees and track submission status. Respond promptly to queries or clarifications raised by CDSCO reviewers. CDSCO medical device clinical investigation approval will allow initiation of the clinical investigation in India.

Clinical investigation: A study necessary to demonstrate the effectiveness of medical devices

CDSCO medical device clinical investigation approval is required to demonstrate the device achieves its intended purpose and can be used safely in real-world medical settings. By carefully designing a Clinical Investigation Plan aligned with CDSCO guidelines, securing ethics committee clearance, and compiling a complete dossier with risk management integration, sponsors can establish credibility with regulators. Additionally, you have to register the study in CTRI and maintain clear communication with CDSCO. We have provided a detailed guide to help you have a smooth medical device clinical investigation approval journey. For any CDSCO clinical investigation license application support or queries, feel free to drop an email at [email protected] or call/Whatsapp on 9996859227.