License to Conduct Clinical Performance Evaluation for New IVDs

Conducting clinical performance evaluation is critical to ensure the IVDs are accurate and reliable. Notably, IVD clinical performance evaluation is regulated in India. You have to mandatorily secure the MD 25 license to conduct clinical performance evaluation for new IVDs in India.

What is IVD?

In vitro diagnostics (IVD) devices are used to perform medical tests outside the human body on samples like blood, urine, or tissue to detect diseases, monitor health, and guide treatment decisions. They are essential tools in modern healthcare, supporting clinical decisions, precision medicine, and even at-home testing.

IVDs are critical in clinical practice. They are widely used in laboratories and hospitals but some are also available for consumer use at home, such as pregnancy or glucose tests. IVDs play a central role in precision medicine. For example, by analyzing DNA variations to determine which therapies may benefit a patient. Thus, IVDs are non-invasive and highly regulated devices that play a significant role in clinical decisions in healthcare.

What is clinical performance evaluation for new IVDs?

Clinical performance evaluation for new IVDs is the process of generating evidence that the test delivers accurate, reliable, and clinically meaningful results in its intended use population. It ensures that the diagnostic device not only works technically but also provides valid information that supports medical decision-making. It is a regulatory requirement under most frameworks, such as the EU IVDR and CDSCO.

Clinical performance evaluation basically assesses how well an IVD detects, measures, or predicts a clinical condition compared to established reference methods or clinical outcomes. It typically includes scientific validity (link between biomarker and condition), analytical performance (precision, sensitivity, specificity), and clinical performance (real-world diagnostic accuracy). Data may come from clinical studies, biobanks, published literature, or retrospective analyses of patient samples. The evaluation demonstrates that the IVD provides results that are clinically relevant, reproducible, and safe for patient care, forming the basis for regulatory approval and market entry.

Why does clinical performance evaluation matter?

Clinical performance evaluation matters because it ensures that new in vitro diagnostic (IVD) devices are accurate, reliable, and clinically relevant. Hence, clinical performance evaluation for new IVDs plays a role in protecting patient safety and enabling regulatory approval. Without it, diagnostic errors could lead to misdiagnosis, inappropriate treatment, and regulatory rejection.

• Accuracy and reliability: It verifies that the IVD produces consistent and correct results, thereby reducing risks of false positives or false negatives that could harm patients.
• Regulatory compliance: Regulatory authorities require documented evidence of clinical performance before granting market approval.
• Clinical relevance: Demonstrates that the test provides meaningful information for diagnosis, prognosis, or monitoring, thereby ensuring it supports real-world medical decision-making.
• Patient safety: Strong evaluation prevents unsafe or ineffective devices from reaching patients, thereby safeguarding public health.
• Market access and trust: Robust evidence builds confidence among clinicians, regulators, and patients, thereby enabling adoption and commercial success.

However, if clinical performance evaluation for new IVDs is not done properly, it will lead to regulatory rejection delaying or blocking market entry. Additionally, it will also lead to clinical harm due to misdiagnosis or inappropriate treatment. Moreover, it will lead to loss of credibility of the IVD among healthcare providers and patients. Therefore, clinical performance evaluation is the bridge between laboratory innovation and safe and effective patient care.

CDSCO license to conduct clinical performance evaluation for new IVDs in India

To conduct clinical performance evaluation for new IVDs in India, you need to mandatorily secure a license. CDSCO, the apex medical device regulatory body, regulates and oversees IVD clinical performance evaluation in India. Any manufacturer or importer who intends to conduct a clinical performance evaluation of a new in-vitro diagnostic needs to apply to the Central Licensing Authority.

• MD-24: The application to conduct IVD clinical performance evaluation in India is filed under MD-24. 
• MD-25: The license to conduct clinical performance evaluation for new IVDs in India is granted under MD-25.

Who can apply?

Any manufacturer or importer who wishes to conduct clinical performance evaluation of new IVDs in India can make an application to the CLA.

Conditions for conducting clinical performance evaluation

• The clinical investigation plan must be registered and approved through the Clinical Trial Registry of India.
• The evaluation must follow the approved clinical evaluation plan and Good Clinical Practice (GCP) guidelines issued by the CDSCO.
• The analysis must begin within one year of receiving permission. Otherwise, fresh approval is required.
• Sponsors must submit an annual report of the analysis to the Central Licensing Authority (CLA), and notify within 30 days if the study is terminated.
• Sponsors and associated personnel are subject to audits by authorized CLA officers.
• Any additional conditions or exemptions imposed by the CLA during approval must be strictly followed.
• In case of subject injury, sponsors must provide appropriate medical facilities.
• If sponsors fail to comply, the CLA may suspend or cancel permission (partly or wholly).
• Sponsors may appeal such orders to the Central Government within 30 days, and the government must resolve the appeal within 60 days.

Documents required to obtain license to conduct clinical performance evaluation for new IVDs in India

We have provided an overview of the documents required.

• Complete medical device description
• Performance evaluation report by central device testing lab
• In house performance evaluation data
• Performance evaluation plan
• Case report form and undertaking as prescribed in the seventh schedule
• Approval through the registered ethics committee
• Quantity and source of sample
• Duration of evaluation
• Laboratories participating in the study. Additionally, an undertaking that the IVD conforms to the rules and precaution has been taken to protect the health and safety of the subjects.

For a detailed list of documents and document preparation support, feel free to get in touch with us.

Fee required

A fee of Rs. 25000 will be required for obtaining the permission to carry out a clinical performance evaluation of a new IVD.

How to apply for the license to conduct clinical performance evaluation for new IVDs in India?

1. Register on the CDSCO official online portal SUGAM.
2. An application for the grant of permission to conduct clinical performance evaluation has to be done on Form MD 24. The application should be addressed to the central licensing authority (CLA).
3. Submit all the necessary supporting documents on the online portal.
4. Pay the necessary licensing fees on SUGAM.
5. The authorities will review the application.
6. If the application complies with the regulations, the CLA will grant the permission to conduct clinical performance evaluation for new IVDs in India on Form MD 25.

5 Pro tips for smooth license application

1. Obtain an undertaking from investigators.
2. Ensure the clinical performance evaluation for new IVDs plan clearly states the objective, scientific/medical/technical grounds, and scope of the evaluation.
3. Secure approval from an Ethics Committee registered with the CLA.
4. Register the clinical evaluation with the Clinical Trial Registry of India before enrolling the first participant.
5. Initiate the evaluation only after Ethics Committee approval of the registered plan.

Therefore, clinical evaluation has to be performed to demonstrate the IVD provides results that are clinically relevant, reproducible, and safe for patient care. This forms the basis for regulatory approval and market entry. To conduct clinical performance evaluation for new IVDs in India, you need to mandatorily secure the Form MD 25 license from CDSCO. Navigating the licensing requirements and the application pathway can be a tricky task. Fret not! Our team will be more than happy to help you. Drop an email at [email protected] or call/Whatsapp on 9996859227 to have a smooth IVD clinical performance evaluation license application journey.