DCGI Mandates BIS Compliance for Medical Devices and IVD Laboratories
To ensure the quality and safety of medical devices and in-vitro diagnostic (IVD) testing kits, the Drugs Controller General of India (DCGI) has directed manufacturers and testing laboratories to adhere to Bureau of Indian Standards (BIS) for product testing. This directive stems from concerns regarding the use of medical devices that have not been tested according to established norms, potentially compromising product quality and posing health risks.
The DCGI, in a communiqué to medical testing laboratories registered with the Central Drugs Standards Control Organization (CDSCO), emphasized the need for medical devices with available BIS standards to be tested in accordance with the guidelines. The directive seeks to enhance the quality, safety, and performance of medical devices and IVDs, as well as strengthen the pan-India testing infrastructure.
Recognizing the limited availability of BIS standards for the vast range of medical devices used in India, the Ministry of Health and Family Welfare has authorized stakeholders to also evaluate products under the Medical Device Rules (MDR), 2017. This allows for the use of alternative standards when BIS standards are unavailable.
Industry experts welcomed the move, acknowledging the crucial role of BIS testing norms in ensuring the quality and safety of medical devices. Adherence to BIS standards guarantees rigorous testing and evaluation, ensuring compliance with national safety and performance requirements. It also instills trust among healthcare providers and patients, promotes harmonization of industry standards, and helps mitigate risks associated with the use of medical devices.
Licensed manufacturers claiming adherence to BIS standards must demonstrate conformity by getting their products tested at National Accreditation Board for Testing and Calibration Laboratories (NABL)-accredited labs. They can also set up in-house laboratories specifically accredited for BIS standards and publish the test results.
While BIS testing norms play a vital role, the constant evolution and innovation in medical devices may result in products without existing BIS or ISO standards. To address this, MDR 17 permits manufacturers to establish their own product specifications or joint industry standards. However, they must demonstrate compliance through sampling testing as part of a conformity assessment and risk management framework to ensure consistent quality and patient safety.
