CHENNAI: Polymatech Electronics Limited today announced a landmark milestone in India’s medical device sector with the successful registration and commencement of domestic manufacturing of its Vein Finder devices in accordance with the Medical Devices Rules, 2017. This achievement positions Polymatech as the first Indian manufacturer to offer a fully regulated, indigenously developed Vein Finder with a valid CDSCO Registration Number, integrated digital features, and end-to-end domestic manufacturing capability.
This launch reflects Polymatech’s strategic transition toward forward integration, marking its evolution from a specialised chip and module manufacturing company into a product-focused medical technology organisation. As part of this transformation, the company has established a structured product roadmap and plans to introduce new technology products at regular six-month intervals, leveraging its deep expertise in semiconductors, opto-electronics, and system-level integration.
Key Highlights
- First in India: The first CDSCO-registered, domestically manufactured Vein Finder.
- Indigenous Tech: Powered by in-house Near-Infrared (NIR) LED technology.
- Certified Quality: ISO 13485:2016, ISO 9001:2015, and ISO 14001:2015 standards.
- Safety: CE-compliant under the EU Low Voltage Directive (2014/35/EU).
- Strategic Pivot: Transition from chips and modules to a product-led medical technology portfolio.
- Growth Cadence: Structured product pipeline with new launches planned every six months.
- Market Reach: Pan-India rollout and global market expansion underway.
Regulatory Compliance and Quality Assurance, the Vein Finder devices are registered with the Central Drugs Standard Control Organisation (CDSCO) as Class A (non-sterile, non-measuring) medical devices. In line with regulatory requirements, all unit packaging prominently displays the CDSCO Registration Number, ensuring traceability, transparency, and compliance for clinical use across India.
This regulatory clearance is supported by a comprehensive and audited quality framework, including:
- ISO 13485:2016 – Quality Management System for Medical Devices
- ISO 9001:2015 – Quality Management System
- ISO 14001:2015 – Environmental Management System
- CE Compliance under the EU Low Voltage Directive (2014/35/EU) for electrical safety
Collectively, these certifications establish Polymatech’s readiness to serve regulated domestic and international markets while ensuring consistent quality, safety, and environmental responsibility. While vein finder devices have previously been available in India primarily through imports and resellers, Polymatech offers the first fully regulated, Indian-made alternative, marking a shift from import dependence toward strengthened national healthcare self-reliance.
Powered by Indigenous Innovation At the core of the device is Polymatech’s proprietary Near-Infrared (NIR) LED platform, built on the company’s expertise in NIR chip development since 2021. The technology enables precise illumination control, high-contrast vein visualisation, and reliable performance in clinical environments within a compact, handheld form factor.
Through vertical integration of NIR LEDs, electronics, and system design, Polymatech enhances supply-chain resilience and significantly reduces reliance on foreign components. Printed Circuit Boards (PCBs) are currently manufactured at Polymatech’s subsidiary in Estonia, with plans to transition production to Polymatech Industrial Park in Raipur, Chhattisgarh, supporting phased localisation under the Make in India initiative.
Designed for Clinical Excellence Developed with direct input from healthcare professionals, the Vein Finder incorporates features optimised for clinical workflows:
- Real-time Projection: High-definition, on-skin vein visualisation.
- Smart Connectivity: Wireless Bluetooth connectivity for secure data transfer.
- Digital Documentation: On-device storage of images and procedural session data.
- Future-Ready Architecture: Designed to support analytics, training, and workflow evaluation.
These non-invasive assistive capabilities improve clinical efficiency, reduce multiple puncture attempts, and enhance patient comfort.
Commenting on the milestone, Mr. Eswara Rao Nandam, Managing Director and CEO, Polymatech Electronics Limited, 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.”
Global Market Readiness and Expansion, with CDSCO registration secured and CE compliance established, Polymatech is actively advancing regulatory pathways for US FDA clearance, CE marking under the EU Medical Device Regulation (MDR), and country-specific approvals across Gulf Cooperation Council (GCC) and ASEAN markets. The company is preparing for pan-India commercial rollout through authorised partners while progressively enabling international market entry.
