IVD Clinical Performance Evaluations
(Forms MD-24, MD-25)
Navigate the mandatory Clinical Performance Evaluation (CPE) requirements for introducing innovative In Vitro Diagnostic (IVD) devices to the Indian market.
Consult Our CDSCO Experts
What Are Forms MD-24 & MD-25?
For manufacturers, importers, and CROs, conducting a Clinical Performance Evaluation (CPE) is a non-negotiable step in gaining regulatory approval for new IVDs. This rigorous evaluation ensures the diagnostic accuracy, reliability, and safety of the device when analyzing human samples.
Form MD-24: Application
The comprehensive application submitted via the Sugam portal. It details the proposed CPE plan, device specifications, and pre-existing in-house performance data.
Form MD-25: Permission
The official CDSCO authorization. Valid for 2 years, it grants legal permission to initiate the study based on the approved ethical and scientific plan.
The CPE Submission Process
Develop the Evaluation Plan (PEP)
Create a meticulous PEP detailing study design, sample collection protocols, and statistical analysis plans.
Obtain Ethical Committee (EC) Approval
The PEP must pass rigorous review by a CDSCO-registered independent Ethics Committee to ensure subject welfare.
Site & Investigator Selection
Identify qualified clinical laboratories and lead investigators equipped with the necessary expertise.
Compile Device Information
Gather technical specifications, in-house analytical data (sensitivity/specificity), and comprehensive risk assessments.
CDSCO Sugam Submission
Submit Form MD-24 electronically with all supporting dossier files via the official portal.
Regulatory Review & Grant
Following expert review (typically 1-2 months), CDSCO grants the MD-25 permission, obligating the study to commence within one year.
Expert CPE Support
Navigating IVD performance evaluation requirements demands deep scientific and regulatory fluency. We streamline the process from protocol design to final approval.
- Evaluation protocol review & optimization
- Meticulous MD-24 dossier compilation
- EC submission support
- Proactive CDSCO query management