Polymatech Electronics has announced the registration and commencement of domestic manufacturing of its vein finder devices in compliance with the Medical Devices Rules, 2017. The company stated that the devices have received registration from the Central Drugs Standard Control Organisation (CDSCO), enabling regulated domestic manufacturing in India.
According to the company, this development marks the first instance of an Indian manufacturer offering a domestically developed vein finder with a valid CDSCO Registration Number, integrated digital features, and end-to-end domestic manufacturing capability.
Polymatech said the launch reflects its transition from a chip and module manufacturing company to a product-focused medical technology organisation. As part of this shift, the company has outlined a structured product roadmap and plans to introduce new technology products at six-month intervals, drawing on its capabilities in semiconductors, opto-electronics, and system-level integration.
The vein finder devices are registered with CDSCO as Class A medical devices that are non-sterile and non-measuring. Polymatech stated that all unit packaging displays the CDSCO Registration Number to support traceability and regulatory compliance for clinical use in India.
The company said the registration is supported by a quality framework that includes ISO 13485:2016 for medical device quality management systems, ISO 9001:2015 for quality management systems, ISO 14001:2015 for environmental management systems, and CE compliance under the EU Low Voltage Directive (2014/35/EU) for electrical safety.
Polymatech noted that vein finder devices in India have largely been available through imports and resellers. With domestic manufacturing, the company stated that it is offering an Indian-made alternative within the regulated medical device framework.
The company said the device is built on its proprietary near-infrared LED platform, developed as part of its work in NIR chip development since 2021. According to Polymatech, the technology enables illumination control and vein visualisation in a handheld format suitable for clinical environments.
Polymatech stated that vertical integration of NIR LEDs, electronics, and system design reduces reliance on foreign components. Printed circuit boards are currently manufactured at the company’s subsidiary in Estonia, with plans to move production to Polymatech Industrial Park in Raipur, Chhattisgarh, under a phased localisation plan.
The vein finder has been developed with input from healthcare professionals and includes real-time on-skin vein visualisation, Bluetooth connectivity for data transfer, on-device storage of images and procedural data, and an architecture designed to support analytics, training, and workflow evaluation. The company said these features support clinical workflows and assist non-invasive procedures.
Commenting on the development, Eswara Rao Nandam, Managing Director and CEO, Polymatech Electronics, said, “This achievement underscores our commitment to building globally compliant medical devices in India. With CDSCO registration, internationally recognised ISO certifications, and CE compliance in place, we are enabling Indian healthcare institutions to access world-class medical technology manufactured domestically, while preparing for structured expansion into global markets.”
Polymatech stated that, following CDSCO registration and CE compliance, it is progressing regulatory pathways for US FDA clearance, CE marking under the EU Medical Device Regulation, and approvals in Gulf Cooperation Council and ASEAN markets. The company said it is preparing for a pan-India commercial rollout through authorised partners while enabling international market entry.