Performance evaluation (validation) refers to the analytical performance of the IVD with respect to its sensitivity, specificity, and repeatability.

Any Indian manufacturer of IVD can apply for validation under the following categories:

• CDSCO mandated validation for manufacturing license and/or approval
• Third-party validation required by central or state government for a national health program
• Third-party validation requested by manufacturer for marketing purposes, either prior to discussion with regulator or post-licensure

All requests for validation are made online. After submission, an ICMR expert committee assesses suitability. If suitable:

• The manufacturer is informed about shipping modality for IVD.
• The IVD is allotted to a lab with a specified protocol.
• The lab conducts performance evaluation and provides a report within the specified timeframe.

If not suitable, feedback is provided for improvement.

After expert group consultation and stakeholder input, ICMR in conjunction with CDSCO has developed standard validation protocols for IVDs of defined applications (serology or molecular-based diagnosis).

Standard protocols ensure uniformity of validation across IVDs from different manufacturers and maintain quality standards in line with international markets.

ICMR is establishing a network of Medical Device Testing laboratories accredited as per ISO:17025 to conduct IVD validation.

The manufacturer bears the cost of validation as per fixed rates defined by ICMR in consultation with ICMAI. Additionally, if the request is submitted prior to regulator discussion, conditions under ICMR guidelines for Technology Development Collaboration apply. View Guidelines