Drug Controller Mandates BIS Norms For Medical Device Testing
The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has directed clinical tool manufacturers and in-vitro analysis (IVD) screening research laboratories to adhere to the Bureau of Indian Criteria (BIS) for product testing.
This action aims to enhance the high quality, safety, and efficiency of medical gadgets and IVDs while strengthening the PAN-India testing infrastructure.
The regulation can be found in the wake of records suggesting that numerous medical devices were not examined according to well-known standards, potentially endangering items of high quality and positioning health threats.
In a communiqué to Central Drugs Standard Control Organisation (CDSCO) registered medical screening laboratories, the DCGI noted that devices with existing BIS requirements were not being checked per the guidelines.
“It may be guaranteed that the samples of the medical tools comply with the BIS criteria for high quality and efficiency, and appropriately the clinical tools will be examined concerning the demands as prescribed in the BIS standards,” the instruction stated.
While around 6,000 clinical tools are utilized in different medical procedures in India, only 1,500 BIS criteria are currently offered.
In such situations, the Ministry of Health and Family Welfare has accredited assessment products under the Medical Device Rules (MDR), 2017. “If no BIS standards are offered, after that just other standards of the MDR might be applied,” it made clear.
India heavily depends on imported clinical devices, accounting for 80% of its products. Importing, production, or marketing these tools calls for a certificate.
The CDSCO, through the Pharmacopoeia Commission, has established its screening requirements lined up with WHO norms, with MDR functioning as a compliance list for makers.
Where BIS or MDR requirements are inaccessible, screening may adapt criteria developed by the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC).
Industry experts have welcomed the step, citing the crucial duty of BIS screening norms in guaranteeing the quality, safety, and security of clinical devices, advertising harmonization of industry criteria, and mitigating dangers associated with device usage, thus securing public health and boosting India’s healthcare framework.
