Polymatech Electronics Limited announced a major milestone for India’s medical device industry with the successful regulatory approval and start of domestic manufacturing of its Vein Finder devices under the Medical Devices Rules, 2017. With this achievement, Polymatech becomes the first Indian company to design, manufacture, and commercialize a fully compliant Vein Finder that carries a valid CDSCO Registration Number. The device combines indigenous development, integrated digital functionality, and end-to-end manufacturing within India, reinforcing the company’s role in advancing locally produced medical technology.

The launch reflects Polymatech’s strategic shift toward forward integration as it evolves from a company focused on semiconductor chips and modules into a product-driven medical technology organization. As part of this transition, the company has built a structured product roadmap that supports the introduction of new medical technology offerings at six month intervals. This approach is supported by Polymatech’s long-standing expertise in semiconductors, optoelectronics, and full system integration, allowing it to move confidently into regulated healthcare products.

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The Vein Finder is registered with the Central Drugs Standard Control Organisation as a Class A medical device intended for non-sterile and non-measuring use. In accordance with regulatory requirements, all product packaging clearly displays the CDSCO Registration Number to ensure traceability and transparency for clinical use across India. This approval is supported by a robust quality and compliance framework that includes ISO 13485 for medical device quality systems, ISO 9001 for overall quality management, and ISO 14001 for environmental management. The device also meets CE safety requirements under the European Union Low Voltage Directive, demonstrating readiness for regulated domestic and international markets. Until now, vein finder devices in India were largely imported, making Polymatech’s product the first fully regulated Indian-made alternative that reduces reliance on foreign suppliers.

At the core of the device is Polymatech’s proprietary Near Infrared LED platform, developed through in-house research and chip development efforts that began in 2021. This technology enables precise illumination, clear vein visualization, and dependable performance in clinical environments, all within a compact handheld design. By vertically integrating NIR LEDs, electronics, and system architecture, Polymatech strengthens supply chain resilience and limits dependence on imported components. Printed circuit boards are currently produced at the company’s subsidiary in Estonia, with plans underway to shift production to Polymatech Industrial Park in Raipur, Chhattisgarh, supporting phased localization under the Make in India initiative.

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The Vein Finder was designed with direct input from healthcare professionals to ensure it fits seamlessly into real-world clinical workflows. It offers real-time, high-definition vein projection directly on the skin, wireless Bluetooth connectivity for secure data transfer, and on-device storage for images and procedural records. Its architecture is designed to support future capabilities such as analytics, training, and workflow evaluation. These non-invasive features help improve efficiency for clinicians, reduce repeated needle attempts, and enhance patient comfort during procedures.

Commenting on the achievement, Mr. Eswara Rao Nandam, Managing Director and CEO of Polymatech Electronics Limited, said the milestone reflects the company’s commitment to building globally compliant medical devices within India. He noted that with CDSCO approval, internationally recognized ISO certifications, and CE compliance now in place, Polymatech is enabling Indian healthcare institutions to access high-quality medical technology manufactured domestically while laying the groundwork for structured expansion into global markets.

With regulatory approval secured in India and CE compliance established, Polymatech is actively progressing toward additional international clearances, including US FDA approval, CE marking under the European Union Medical Device Regulation, and country-specific authorizations across GCC and ASEAN regions. The company is preparing for a nationwide commercial rollout through authorized partners while gradually enabling entry into global markets, positioning its Vein Finder as a competitive and scalable solution worldwide.

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