The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has directed medical device manufacturers and in-vitro diagnostic (IVD) testing laboratories to adhere to the Bureau of Indian Standards (BIS) for product testing. This decision comes in response to concerns about medical devices not being tested according to established norms, potentially compromising quality and posing health risks.
In a communication to laboratories registered with the Central Drugs Standards Control Organization (CDSCO), Raghuvanshi emphasized the importance of testing medical devices against BIS standards to ensure quality and performance. However, with around 6,000 medical devices used in India and only approximately 1,500 BIS standards available, the Ministry of Health and Family Welfare has allowed stakeholders to evaluate products under the Medical Device Rules (MDR), 2017, when BIS standards are not available.
The directive aims to enhance the quality, safety, and performance of medical devices and IVDs, and to strengthen the national testing infrastructure. As India relies heavily on imported medical devices, which make up 80% of its supply, rigorous testing is essential. The CDSCO has set its own standards aligned with WHO norms, and in the absence of BIS or MDR standards, testing can follow ISO or IEC standards.
Industry experts have welcomed the move, highlighting the role of BIS norms in ensuring device reliability and public safety. Jatin Mahajan, secretary of the Association of Diagnostic Manufacturers of India, noted that adherence to BIS standards would promote industry harmonization and mitigate risks associated with medical devices.
Rajiv Nath, forum coordinator at the Association of Indian Manufacturers of Medical Devices (AiMeD), added that manufacturers claiming to adhere to BIS standards must demonstrate conformity through testing at NABL-accredited labs or in-house laboratories specifically accredited for BIS standards. He emphasized the importance of a conformity assessment and risk management framework to assure consistent quality and patient safety.
As reported by Medical Buyer, the DCGI’s directive is a significant step towards improving the quality and safety of medical devices in India, ensuring that all devices meet rigorous testing and performance standards.