Importer & Manufacturer | Source: CDSCO
Published On: 29-06-2026
Enforcement Date: 29 June, 2026
CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29/06/2026
CDSCO has released an updated list of laboratories authorized to conduct Performance Evaluation studies for In Vitro Diagnostic (IVD) medical devices. The revised list identifies approved laboratories eligible to perform analytical and clinical performance evaluations required during regulatory submissions. Importers and manufacturers should ensure that future performance evaluation studies are conducted only through laboratories included in the updated CDSCO list.
The Central Drugs Standard Control Organization (CDSCO) has issued an updated notification revising the list of laboratories recognized for conducting Performance Evaluation studies of In Vitro Diagnostic (IVD) medical devices. These laboratories are authorized to perform analytical and clinical performance evaluations required for regulatory approvals under the Medical Devices Rules, 2017.
The update aims to streamline the regulatory review process by ensuring that only competent and recognized laboratories generate performance data submitted with MD-14, MD-15 and other relevant applications. Manufacturers and importers planning to register new IVD products or respond to regulatory queries should verify that their selected laboratory appears on the latest CDSCO-approved list.
Compliance with this updated list will help avoid regulatory deficiencies, delays in application processing, and rejection of performance evaluation reports generated by non-recognized laboratories.
Applicable For: Importer & Manufacturer
Reference Number: NA
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