CDSCO Approval for Medical Device Clinical Investigations in India

In India, Medical Devices must meet established safety and quality standards before they can be used in healthcare. The approval process for Medical Device clinical investigation involves a regulated process that includes development, testing, clinical investigation, and review by the Central Licensing Authority. Understanding this process is important for manufacturers and sponsors seeking to introduce new devices in the country.

Medical Devices in India

Medical Devices are an essential part of the healthcare system in India and contribute significantly to improving patient care. They are commonly used for purposes such as screening, diagnosis, treatment, and monitoring of health conditions.

According to the Indian Medical Devices Rules (IMDR), 2017, Medical Devices include:

Products used for in vitro diagnostic (IVD) purposes, surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, and blood or blood component collection bags with or without anticoagulants.
Substances such as mechanical contraceptives, including condoms, intrauterine devices, and tubal rings, as well as disinfectants and insecticides used for medical purposes.
Devices that are notified under sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940.

India is considered one of the top 20 Medical Device markets globally, reflecting the increasing demand for healthcare technologies. However, domestic production is still limited, and nearly 70% of Medical Devices used in the country are imported. To introduce new devices safely, manufacturers must obtain Central Drugs Standard Control Organization (CDSCO) approval in India, ensuring that investigational devices meet regulatory standards for safety, quality, and performance.

Regulatory Framework for Medical Devices Clinical Investigation in India

In India, the regulation of Medical Devices is mainly carried out by the CDSCO under the Ministry of Health and Family Welfare. Earlier, there were no separate regulations for Medical Devices, and only a few notified devices were regulated under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.

To address this gap, IMDR 2017 were introduced and later strengthened through the Medical Devices (Amendment) Rules, 2020.

Major regulatory functions of CDSCO include:

Granting registration certificates to notified bodies for auditing Class C and D.
Issuing import licenses for Medical Devices.
Granting manufacturing licenses.
Providing test licenses and overseeing IVD clinical trial regulations in India.
Granting permission to conduct clinical investigations.

These activities help ensure that Medical Devices in India meet the required safety and quality standards.

Classification of Medical Devices

In India, Medical Devices are classified under IMDR 2017 based on the level of risk associated with the device and its intended use.1 This classification helps regulatory authorities determine the level of regulatory oversight required for different types of Medical Devices.

Table 1: Risk-Based Classification of Medical Device Clinical Evaluation in India

Class	Risk Level to Patient
Class A	Low risk
Class B	Low-to-moderate risk
Class C	Moderate-to-high risk
Class D	High risk

Risk classification of Medical Devices is based on their intended use, such as non-invasive devices, invasive devices, surgically invasive devices, and other specialized categories. Generally, the State Licensing Authority regulates Class A and Class B devices, while Class C and Class D devices are regulated by the Central licensing authority.

Approval Pathway Of Medical Device Clinical Performance Evaluation in India

The approval of Medical Devices in India follows a structured regulatory process under IMDR 2017. The CDSCO Medical Device clinical investigation in India framework ensures that devices meet the required standards of safety, quality, and performance before they are marketed. The pathway generally begins with the development of the device and continues through testing, clinical investigation, and regulatory approval.

The major steps involved in the approval pathway include:

Product development/prototype stage, where the investigational device is designed and initially tested.
Obtaining a test license for manufacturing or importing the device for testing (Form MD-12/MD-13 or MD-16/MD-17, respectively).
Clinical investigation approval, where permission to conduct the investigation is applied using MD-22 application India and granted in Form MD-23.
Permission to import or manufacture investigational devices through Form MD-26, with approval granted in Form MD-27.
Manufacturing or import license before commercial marketing.

All applications for these steps must be submitted via the CDSCO SUGAM portal submission, ensuring efficient processing, tracking, and regulatory compliance. These steps help guarantee that Medical Devices are rigorously evaluated before entering India’s healthcare system, supporting safety, quality, and innovation.

CDSCO Approval Process for Clinical Investigation of Medical Devices

Clinical investigation is an important step in the Medical Device approval pathway in India, as it helps generate evidence on the device’s safety, performance, and effectiveness in human subjects. This stage bridges the gap between early device testing and final regulatory approval for market entry. In India, approval for clinical investigations is granted by the Central Licensing Authority (CLA) under CDSCO, and sponsors must follow specific regulatory procedures before initiating studies.

Key steps for obtaining CDSCO approval include the following:

For obtaining a test license:

Submit Form MD-12 to the manufacturer for manufacturing a small quantity of the device for clinical investigation, evaluation, and test on NSWS portal
Pay the required application fee for each Medical Device and submit supporting documents, such as device description, equipment list, manufacturing details, and technical personnel information, to CLA for approval of the above.
The CLA reviews and verifies all submitted information and documents and grants permission for test license if satisfied.

For approval to conduct a clinical investigation:

Sponsors submit Form MD-22 along with required fees and documents to CLA to seek approval to conduct a clinical investigation.
Obtain Ethics Committee approval in India through acceptance of the Clinical Investigation Plan (CIP) by a registered Independent Ethics Committee (IEC).
Clinical investigations should conform to the approved CIP, follow Good Clinical Practice (GCP) guidelines by CDSCO, and should be registered in the Clinical Trial Registry of India (CTRI).

Once the CLA is satisfied with the submitted information and compliance with IMDR 2017 requirements, permission is granted to conduct the clinical investigation. If the authority is not satisfied, the application may be rejected and the reasons recorded in writing.

Figure1

Conclusion

Obtaining CDSCO clinical trial approval in India for Medical Device clinical investigations requires strict adherence to the Medical Devices Rules, 2017. Sponsors and manufacturers must submit the necessary forms, secure test licenses, and comply with Good Clinical Practice (GCP) guidelines. The Central Licensing Authority evaluates each application to ensure the safety, quality, and performance of the investigational device. By completing these steps and maintaining proper documentation, organizations can successfully conduct a Medical Device clinical performance evaluation and support the development of safe, effective devices for India’s healthcare system.

References

A review of Medical Device regulations in India, comparison with European Union and way-ahead – PMC. Accessed March 12, 2026. https://pmc.ncbi.nlm.nih.gov/articles/PMC8815674/#sec1-5
Sharma D, Chandra A. Medical Device Rules – 2017, India: An Insight. ACCTRA. 2020;7(2):126-134. doi:10.2174/2666255813666190912114043
(PDF) A Review on Approval Process and Regulation of Medical Devices as per US FDA and CDSCO. Accessed March 12, 2026. https://www.researchgate.net/publication/370019210_A_Review_on_Approval_Process_and_Regulation_of_Medical_Devices_as_per_US_FDA_and_CDSCO
Maske TR, Ware DN. THE COMPARISON OF MEDICAL DEVICE REGULATIONS IN INDIA WITH USA, EU: AN QUALITATIVE STUDY. 2023;8(3).
PowerPoint Presentation. Accessed March 12, 2026. https://www.cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/RegulatoryMDR-2017.pdf?utm_source=chatgpt.com