The drug controller establishes BIS standards for testing medical devices

(MENAFN-KNN India) New Delhi, May 31 (KNN) Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has directed medical device manufacturers and in vitro diagnostic (IVD) laboratories to follow the recommendations of the Bureau of Indian Standards (BIS) for product testing.

The move is aimed at improving the quality, safety and performance of medical devices and in vitro diagnostic medical devices, while strengthening PAN-India’s testing infrastructure.

The directive comes following reports indicating that several medical devices had not been tested to set standards, potentially compromising product quality and posing health risks.

In a notification to Central Drugs Standard Organization (CDSCO) registered testing laboratories, DCGI noted that products complying with existing BIS standards were not tested as per the guidelines.

“It can be ensured that samples of medical devices meet the BIS standards in terms of quality and performance, and therefore medical devices will be tested against the requirements set out in the BIS standards,” the directive states.

While around 6,000 medical devices are used in various medical procedures in India, only around 1,500 BIS standards are currently available.

In such cases, the Ministry of Health and Family Welfare has allowed the products to be assessed under the Medical Devices Regulations (MDR) 2017. “If no BIS standards are available, only other MDR standards can be used,” it explained.

India relies heavily on imported medical devices, which constitute 80% of its supply. Importing, manufacturing or selling these devices requires a license.

CDSCO, through the Pharmacopoeia Commission, has established its own testing standards aligned with WHO standards, with the MDR serving as a compliance checklist for manufacturers.

If BIS or MDR standards are unavailable, testing may be in accordance with standards established by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

Industry experts welcomed the move, citing the crucial role of BIS testing standards in ensuring the quality and safety of medical devices, promoting harmonization of industry standards and reducing risks associated with the use of devices, thereby protecting public health and improving India’s healthcare infrastructure.

(KNN Office)

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