A major milestone has been achieved in the Indian medical devices market with the registration of vein finder devices by Polymatech Electronics Ltd, making it the first Indian company in the country to manufacture these devices according to CDSCO standards. But can Indian NIR technology cut its dependence on foreign-imported devices while maintaining international quality standards in the health sector?
CDSCO Registration and quality certification attained:
Polymatech Electronics Ltd has also declared the successful registration of Vein Finder devices with respect to the ISO 13485:2016 certification and the Central Drugs Standard Control Organisation (CDSCO). It has been registered as Class A (Non-Sterile, Non-Measuring) Medical Device under the Medical Devices Rules, 2017 as amended.
With this, Polymatech has become the first company in India to integrate controlled local production, indigenous developed NIR LED technology, and digital features for this type of product. It is a result of the company’s transformation from making components to completely developed medical innovations.
Indigenous technologies and local production emphasis:
At the heart of the Vein Finder devices lies the proprietary NIR LED platform from Polymatech, built upon the experience of the firm in the field of NIR chips since 2021. The innovation facilitates compact designs with controlled illumination and stable clinical results. The integration of LED manufacturing with the other electronic components of the system safeguards supply chain integrity.
The Printed Circuit Boards are currently being produced at its Estonian subsidiary, and this production will commence at its Raipur unit located in the state of Chhattisgarh. The software development process will be managed by its promoters’ firm and upgraded periodically.
Clinical features and global expansion plans
The devices include real-time on-screen projection, Bluetooth data transfer, on-device data storage, and support for future analytics, aimed at improving clinical efficiency and patient comfort.
Commenting on the milestone, Eswara Rao Nandam, Managing Director and CEO of Polymatech Electronics Ltd, said, “This achievement underscores our dedication to innovating regulated, technology-driven medical devices in India. By leveraging indigenous NIR LED advancements, clinician-informed design, and full CDSCO compliance, Polymatech is bolstering the nation’s medical device ecosystem.”
Polymatech is now pursuing global certifications, including US FDA clearance, CE marking in Europe, GCC registrations, and ASEAN approvals, alongside plans for pan-India distribution through authorised channels.
