AiMeD welcomes relaunch of DoP’s SMDI sub-schemes for medical device industry

The Association of Indian Medical Device Industry (AiMeD) has welcomed the Department of Pharmaceuticals’ (DoP) relaunch of applications under the Scheme for Strengthening of Medical Device Industry (SMDI).

According to AiMeD, the two sub-schemes—the Marginal Investment Scheme for Reducing Import Dependence and the Medical Device Clinical Studies Support Scheme (MDCSS)—are aimed at reducing import reliance, promoting indigenous manufacturing, supporting innovation and strengthening domestic value chains.

Commenting on the development, Rajiv Nath, Forum Coordinator, AiMeD, said, “The relaunched SMDI will benefit Indian manufacturers of critical components, raw materials, and high-value finished devices such as imaging equipment, implants, diagnostic kits, and accessories. Subsidies up to ₹10 crore and support for clinical studies will reduce import dependence, deepen local value chains, and encourage innovation. AiMeD appreciates the Department of Pharmaceuticals for operationalising these important sub-schemes under the SMDI framework.”

AiMeD stated that it also welcomes the clinical studies support scheme, stating that it will enable Indian manufacturers to develop and export higher-value medical devices, including implants. According to the association, clinical studies are required for regulatory approvals in advanced countries and for establishing patient safety claims. It stated that the scheme will help Indian manufacturers compete globally, expand exports and support confidence in the safety and efficacy of medical devices manufactured in India.

The association stated that while the relaunch is a welcome development, its success will depend on implementation, transparent approvals and complementary measures. These include predictable procurement that incentivises higher domestic content, rationalised regulation seeking labelling of packers and relabellers separately from manufacturers, faster product approvals and localisation of components.

AiMeD further stated that sustained support for research and development, testing infrastructure, skill development and industry-academia collaboration will be required to move beyond assembly and build manufacturing capabilities.

According to the association, coordinated implementation of these measures can help position India as a manufacturing hub for medical devices, improve healthcare security and create employment. AiMeD stated that it will continue to work with the Department of Pharmaceuticals and other ministries to support the rollout of the schemes and identify further policy interventions for the growth of India’s medical devices sector.