Introduction
The Department of Pharmaceuticals (DoP) has invited applications from eligible stakeholders to set up common facilities for medical device clusters in India under the Scheme for Strengthening of Medical Device Industry (SMDI).
The initiative aims to strengthen domestic medical device manufacturing, reduce import dependence, and improve access to advanced testing and clinical evaluation facilities across the country.
Talk to our medical device scheme experts today.
Applications Open for Common Facilities for Medical Device Clusters (CFMDC)
In its latest notification, the DoP has called for proposals under the Common Facilities for Medical Device Clusters (CFMDC) sub-scheme. Applications must be submitted by 6 pm on January 31, 2026, and will be evaluated on a First In, First Out (FIFO) basis.
Proposals are to be submitted to the Small Industries Development Bank of India (SIDBI), the authorised Project Management Agency for DoP, through the Udyamimitra portal, which supports MSMEs with financial and non-financial services.
Priority Areas Under the CFMDC Sub-scheme
Priority will be given to applicants who already own land and buildings and are looking to strengthen their existing testing infrastructure through the installation of additional equipment.
Key priority testing areas include:
- Functional testing for cardiac implants and delivery systems
- ISO and ASTM standard testing requiring specialized equipment beyond universal testing machines
- IEC and other internationally recognised standard testing for diagnostic and therapeutic equipment, including infusion pumps, endoscopic systems, high-frequency surgical equipment, X-ray machines, and MRI scanners
- MRI compatibility testing for metallic implants
- Usability engineering for all categories of medical devices
- Clinical performance evaluation for Class B, C, and D in vitro diagnostic medical devices
The objective of this sub-scheme is to strengthen shared infrastructure within medical device clusters, improve product quality, and increase the availability of accredited medical device testing laboratories in India.
Deadline Extended for Other SMDI Sub-schemes
The DoP has also extended the application deadline for two other sub-schemes under SMDI to January 31, 2026, from the earlier deadline of January 10, 2026.
These sub-schemes include:
Marginal Investment Scheme for Reducing Import Dependence
This scheme focuses on promoting domestic manufacturing of key components, raw materials, and accessories used in medical devices, including in vitro diagnostic devices. The goal is to reduce reliance on imported components and strengthen India’s medical device value chain.
Medical Device Clinical Studies Support Scheme
This scheme supports the generation of clinical evidence to demonstrate the safety and performance of medical devices manufactured in India. It aims to improve regulatory acceptance, product credibility, and global market access for Indian medical device manufacturers.
Applications for these two sub-schemes must be submitted to the Life Sciences Sector Skill Development Council (LSSSDC), the authorised Project Management Agency.
Overview of the Scheme for Strengthening of Medical Device Industry (SMDI)
The Central Government launched the Strengthening of Medical Device Industry (SMDI) scheme on November 8, 2024, with a total outlay of Rs. 500 crore. The scheme will run for three years, from FY 2024–25 to FY 2026–27, and includes five sub-schemes.
Other sub-schemes under SMDI are:
Capacity Building and Skill Development in Medical Device Sector
This sub-scheme focuses on bridging gaps in education, training, and research in the medical device sector. It aims to create a skilled workforce and support the development of a strong R&D ecosystem.
Medical Device Promotion Scheme
This scheme promotes industry growth through policy dialogue, awareness programs, industry studies, database creation, and collaboration between industry, academia, and policymakers.
Talk to our medical device experts today
How Operon Strategist Helps Medical Device Manufacturers and Clusters
Operon Strategist supports medical device manufacturers, startups, and industry clusters in successfully applying for SMDI sub-schemes. The company provides end-to-end support, including eligibility assessment, proposal drafting, documentation, project structuring, and coordination with SIDBI and LSSSDC.
With strong expertise in medical device regulatory approvals, testing facility setup, quality management systems, and clinical studies planning, Operon Strategist helps applicants align their proposals with DoP requirements and improve approval and execution outcomes.
