Medical device manufacturers/importers who wish to conduct a clinical investigation in India need to obtain permission from the CLA. The CLA is the Central Licensing Authority (CLA) and functions under the CDSCO. The CDSCO is the Central Drugs Standard Control Organisation that regulates all medical devices in India. Additionally, it regulates and monitors all the clinical investigations for medical devices performed in India. In this blog, we have discussed the clinical investigation license application procedure in India. Additionally, we have provided an overview of the documents required for the application process. Furthermore, we have highlighted the Indian regulations for conducting clinical investigations for medical devices.

What is clinical investigation?

Clinical investigation is a study performed to demonstrate the safety and performance of a medical device in human subjects. Basically, the aim is to establish and verify clinical safety. Moreover, clinical investigation focusses on preventing and reducing risks that may affect patients and personnel. The study involves systematic testing of medical devices according to an ethical and scientifically preapproved clinical investigation protocol. Thus, clinical investigation studies are focused on continuous improvement of treatment methods by evaluating device performance and adverse events.

Therefore, clinical investigation studies are required to develop novel treatment methods for different diseases and conditions. Clinical investigation is usually one of the final steps of a long research process for developing a new medical device. Hence, the studies have to be performed to collect evidence demonstrating the treatment using the new medical device is effective and safe. Notably, 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 regulatory guidelines.

Two major branches of clinical investigation:

• Pilot investigation: Pilot investigation is the assessment of the medical device’s mechanism and workability. Notably, this is the first study performed in humans. This investigation is performed to collect data demonstrating the performance and safety of a device in humans. It is usually performed in a small group of patients having a particular condition or disease. Furthermore, the study is used to evaluate logistics of the pivotal investigation.

• Pivotal investigation: Pivotal investigation is performed to collect data on the safety and performance standard of the medical device. Moreover, this study is usually carried out on a larger population with the disease or condition. This final study is done to evaluate the safety and quality standards of the medical devices.

Application for conducting clinical investigation in India

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 permission to conduct clinical investigations for medical devices will be granted under Form MD-23.

Essential documents required

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

We have provided an overview of the documents required while applying for the permission 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 be more than happy to prepare and collate all the documents required as per application guidelines.

Conditions for conducting clinical investigation in India

The regulatory body has laid down certain conditions for conducting clinical investigation in India. Furthermore, 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 clinical investigation has to be performed according to the pre-approved clinical investigation plan and Good Clinical Practices Guidelines.
• The investigation study can start only after the registered Ethics Committee approves the clinical investigation plan.
• 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. Or else, prior approval from the CLA will be required to start the clinical investigation.
• 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 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.
• Within 14 days of occurrence of an unexpected serious adverse event during the clinical investigation, the sponsor is required to inform the CLA.
• The applicant is required to provide complete medical management or compensation if any subject is injured or dies during the clinical investigation.

License application process for conducting clinical investigation in India

We have provided an overview of the application process for obtaining the permission to conduct clinical investigation.

1. The application should be addressed to the CLA and CDSCO.
2. The application has to be filed under Form MD-22. The application for conducting clinical investigation along with the required fees and relevant documents have to be submitted to the official online portal, SUGAM.
3. The application will be reviewed and verified by the regulatory officials.
4. 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. Approximately 1 to 2 months are required to secure the permission under Form MD-23. However, if the CLA feels the application does not comply with the regulations, it will reject the application. Furthermore, the CLA will provide the reasons for rejecting the application within 90 days from the date of application.

Validity of Form MD-23 license

Unless suspended or cancelled, the Form MD-23 license 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.

Pro tips for smooth license application process for conducting clinical investigation in India

• The clinical investigation plan should be approved by the registered Ethics Committee prior to initiating the investigation.
• For the clinical investigation license application process, the biocompatibility test reports are mandatory.
• The ethics committee approval letter is a mandatory requirement while applying for the license to conduct clinical investigation in India.
• The first study participant should be enrolled within 1 year of permission grant and is required prior to clinical investigation initiation.
• The applicant has to provide compensation as per the MDR, 2017, in case of injury or death of a subject while conducting the clinical investigation.

Therefore, the application process for obtaining a license to conduct clinical investigation in India is difficult and painstaking. Any mirror issues or errors in the application can lead to rejection of the application. The medical devices clinical investigation has to be highly regulated to protect patients and study volunteers. Are you planning to securing the Form MD-23 license? Fret not! Our team of experts can make the application process a cake walk for you. Drop an email at [email protected] or call/Whatsapp on 9996859227 and we will help you.