The Indian Council of Medical Research (“IMCR”) and the Central Drugs Standard Control Organization (“CDSCO”) have collaborated to develop standard evaluation protocols for In-Vitro Diagnostic (‘IVD’) devices under the Medical Devices Rules, 2017. These protocols aim to streamline and standardize performance evaluation of IVDs, with a view to ensure regulatory compliance. As part of this protocol, the draft for the Human Metapneumovirus Real-Time PCR Kit, including its operational and test performance characteristics, has been made available for public consultation.
Interested parties are invited to submit feedback by 15th March, 2025 at ivdevaluation@gmail.com, following the prescribed format.
After the consultation period, ICMR and CDSCO will review the feedback and finalize the protocols, with limited scope for modifications thereafter.
The Draft Standard is linked below for your reference.
Source: Central Drugs Standard Control Organization
