Govt Enforces BIS Standards for Medical Devices & IVDs

The Union Ministry of Health and Family Welfare authorized laboratories to test medical devices for manufacturers under Chapter X of MDR, 2017.

To ensure the quality and safety of medical devices and in-vitro diagnostics (IVDs), the Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, has mandated that all such products sold in the country comply with the standards prescribed by the Bureau of Indian Standards (BIS).

Dr Raghuvanshi issued a circular detailing the new requirements to all stakeholders, including medical device testing laboratories and manufacturing associations.

“It must be ensured that samples of medical devices comply with BIS standards for quality and performance. Devices should be tested according to BIS standards,” stated the regulator. If no BIS standard is available, the standards specified in Rule 7 of the Medical Devices Rules (MDR) will apply.

Additionally, to bolster the testing infrastructure, the Union Ministry of Health and Family Welfare authorized laboratories to test or evaluate medical devices on behalf of manufacturers under Chapter X of MDR, 2017.

The implementation of MDR 2017 began on January 1, 2018. It replaces the earlier Drug Rules, 1945, for regulating medical devices and IVDs.

According to Rule 7 of the MDR, medical devices must conform to BIS standards as established under the Bureau of Indian Standards Act, 1985.

If BIS standards are unavailable, devices should adhere to standards set by the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), or other relevant pharmacopoeial standards.

Where these standards do not exist, devices should meet the validated manufacturer’s standards.

“It has been observed that medical devices with available BIS standards are not being tested according to these standards,” noted the drug regulator.

The central drug regulator has urged private medical device testing facilities to register as Medical Device Testing Laboratories (MDTL) to enhance the testing network and meet the growing demand for quality tests.

CDSCO’s Role

The Central Drugs Standard Control Organisation (CDSCO) oversees the quality, safety, and performance of medical devices under the Medical Device Rules, 2017.

Following the issuance of two notifications on February 11, 2020, all medical devices have been brought under the Drugs and Cosmetics Act, 1940, and the MDR, 2017.

The expanding scope of regulated devices has increased the need for more testing facilities to ensure timely market entry for both domestically produced and imported products.

So far, several private testing labs have been registered under MDR, 2017, to test and evaluate medical devices on behalf of manufacturers. The CDSCO is actively identifying existing private labs capable of testing medical devices to register them under MDR, 2017.

These labs must be capable of conducting various tests, including physical, chemical, microbiological, mechanical, and electrical evaluations.

By September 2023, the CDSCO approved 39 laboratories across India to conduct tests on medical devices under Form MD-40 of the MDR, 2017.

This includes nine MDTLs approved in 2023, such as HLL Lifecare Ltd and the Atal Incubation Centre (AIC) Medivalley at Andhra Pradesh MedTech Zone (AMTZ).

In December 2022, the DCGI called on laboratories with adequate testing capacity and quality accreditation to apply for registration as MDTLs. This initiative aims to strengthen the network of medical device testing laboratories in India.

The Indian medical device sector has historically been under-regulated. The Medical Device Rules, 2017, introduced by the Ministry of Health and Family Welfare, have progressively established a comprehensive regulatory framework.

By 2023, all medical devices were brought under a phased licensing regime, ensuring rigorous quality, safety, and efficacy standards. The recent emphasis on BIS standards marks another step towards robust regulatory oversight, aiming to enhance the safety and effectiveness of medical devices available in India.