ICMR and CDSCO have jointly issued draft protocols under the Medical Devices Rules, 2017 for evaluating In-Vitro Diagnostics (IVDs) intended for tuberculosis testing. These cover both analytical and clinical performance aspects for pulmonary and drug-resistant TB. Stakeholders are invited to provide comments by 7th September 2025, which will contribute to the finalization of the protocols.
The Indian Council of Medical Research (ICMR) in collaboration with the Central Drugs Standard Control Organization (CDSCO) has released draft standard protocols for the evaluation of In-Vitro Diagnostics (IVDs) used in tuberculosis detection.
Issued under the Medical Devices Rules, 2017, these drafts address both analytical and clinical performance requirements for pulmonary and drug-resistant TB diagnostics.
The intent is to establish uniform scientific standards ensuring safety, reliability, and regulatory compliance of TB IVDs. These protocols are expected to guide manufacturers and importers in preparing performance evaluation dossiers for regulatory approval.
Stakeholders, including industry representatives, healthcare professionals, and researchers, are encouraged to submit feedback by 7th September 2025 via the prescribed format to ivdevaluation@gmail.com, enabling refinement and effective implementation of these protocols.