India’s Medical Device Regulatory Update 2024

In recent months, India has made significant strides in reshaping the regulatory framework of its medical device industry. These initiatives are designed to improve the Indian medical device market and contain healthcare costs.

Updates to Medical Device Licensing Requirements

The Medical Device Rules Act expanded the number of devices requiring regulatory oversight. This marks a significant shift from the earlier regulation where only 35 device categories needed registration. The transition has not been seamless, as shown by repeated extensions of compliance deadlines. Initially, the Act stipulated that non-regulated Class A and B devices should be registered by October 1, 2022. However, this deadline was extended to March 31, 2023. Similarly, the deadline for Class C and D non-regulated devices was extended to October 1, 2023. These extensions indicate the complexities involved in adapting to new regulations. The latest extension allows manufacturers and importers of higher-risk Class C and D devices additional time to meet registration requirements due to a backlog in application processing.

Comprehensive Regulation of High-Risk Medical Devices

A landmark announcement from the Central Drugs Standard Control Organization (CDSCO) set October 2023 as the deadline for all Class C and D non-notified medical devices to secure a comprehensive license. This policy represents India’s commitment to reinforce the safety and quality standards of medical devices before they are marketed in the Indian market and focuses particularly on those that carry moderate to high risks, such as certain X-ray machines and ventilators. This approach ensures that only devices that meet stringent safety and efficacy standards will be permitted.

Enhancing Price Controls on Essential Medical Devices

The Indian government’s National Medical Device Policy 2023 underscores a strategic pivot towards boosting domestic production to decrease the country’s reliance on imported medical devices, which currently accounts for about 82% of the market. A cornerstone of this policy is the formation of a National List of Essential Medical Devices which aims to set price ceilings for vital medical equipment. The involvement of a special group, including external experts and various governmental departments, in this initiative demonstrates a robust approach to ensuring affordability in healthcare. This move has sparked concern among international manufacturers, who fear these price caps may restrict their ability to set profitable prices in India and affect their market opportunity.

Industry Implications and Future Outlook

These regulatory updates reflect India’s broader objectives to enhance patient safety, make healthcare more affordable, and support the growth of local industries. While these changes promise to bring stability and expand opportunities within the Indian market, they also present challenges for foreign manufacturers who must navigate these new regulatory landscapes.