Health Ministry Strengthens Regulations for Medical Devices and IVD Manufacturers

The Health Ministry has made significant strides in tightening regulations concerning medical devices and in vitro diagnostic (IVD) manufacturers. These new norms come as a response to the need for ensuring safe utilization of blood samples sourced from blood centres. Every firm involved in the production of IVD reagents is now required to submit an affidavit to the licensed blood centre, alongside a copy to the respective State Licensing Authority and the Central License Approving Authority, confirming that they will accurately record the blood collected and its subsequent use.

Additionally, compliance demands that manufacturers keep detailed records of the quantity of antigens used to avert the potential misuse of Transfusion-Transmissible Infection (TTI) reactive blood bags. This new framework necessitates that manufacturers procure approval from the State Blood Transfusion Council for the collection of reactive blood bags or samples.

Furthermore, in a move to safeguard both employee health and environmental standards, auditors from the Central Drugs Standard Control Organization (CDSCO) will rigorously inspect risk management protocols at manufacturing sites. This ensures that all infectious materials are handled and disposed of according to established regulations, reinforcing a culture of safety within the healthcare ecosystem.

More details on this pivotal shift in healthcare regulation can be found through additional sources.