Indian Army Patient Specific 3D Printed Titanium Cranial Implant Tender Kolkata West Bengal 2026 ISO 9001 CDSCO

Tender Overview

The Indian Army, Department Of Military Affairs, seeks a supplier for a patient specific 3D printed titanium cranial implant sized 98 mm × 75 mm, to be manufactured and supplied from Kolkata, West Bengal. The procurement involves a single implant specification with emphasis on medical-grade titanium fabrication and customized cranial implant production. The contract includes an option clause allowing up to a 25% quantity variance, with extended delivery timelines calculated by a defined formula. Key differentiators include mandatory regulatory compliance and ISO 9001 certification for the bidder or the OEM. This tender requires OEM-level CDSCO approvals and a license for manufacturing and sale of customized cranial implants in India, and the supplier must be CDSCO-listed. No BOQ items are published, suggesting a highly specialized, single-item deployment.

Technical Specifications & Requirements

• Product category: Patient-specific cranial implant, 3D printed titanium
• Dimensions: 98 mm × 75 mm implant
• Material: Medical-grade titanium; 3D printed fabrication
• Standards/Certifications: ISO 9001 certification (bidder or OEM); CDSCO approval and license for manufacturing/sale of customized cranial implants in India; company must be listed on CDSCO site
• Regulatory: OEM ink-signed CDSCO certificate; ensure regulatory compliance for India
• Delivery/Variance: Option to increase quantity by up to 25%; delivery time extension formula based on original and increased quantities, minimum 30 days (if original delivery period < 30 days, extended equals original)
• Delivery start: Based on delivery order terms; exact dates not specified
• EMD/Price: Not disclosed in data; no BOQ items available

Terms, Conditions & Eligibility

• EMD/Payment: Not specified in data; ensure readiness for typical EMD submission per tender terms
• Experience: Demonstrated capability in medical device manufacturing of cranial implants and regulatory compliance
• Documentation: Upload ISO 9001 certificate; CDSCO approval certificate; CDSCO licensing documentation; OEM authorizations
• Delivery: Compliance with delivery timelines tied to contract order and option extension rules; adhere to original delivery period unless option exercised
• Technical compliance: Bidder’s or OEM’s ability to supply patient-specific cranial implants per 98×75 mm requirement; ensure CDSCO listing
• Quality/Traceability: Maintain traceability for titanium implants and manufacturing records as per regulatory norms