Employees State Insurance Corporation Medical Devices Tender India 2026 MDR 2017 ISO 9001 Compliance

Tender Overview

The Employees State Insurance Corporation (ESIC) issued a procurement tender for multiple medical devices, including Non-Rebreather Oxygen Mask (NRBM), Nasogastric (NG) tubes, Intubation stylets, Auto-Disabled syringes for fixed-dose immunization, and Bone Marrow Biopsy Needle. Estimated value is ₹29,815.0 with a sample of 100 NRBM units, 100 NRBM total, 60 NG 14G units, 40 NG 18G units, 100 12G Ryles tubes, 60 14G, 40 18G, plus 10 Stillets (10Fr), 6,000 1mL syringes, and 10 prostatic biopsy guns. Mandatory MDR 2017 compliance and drug/medical device licensing are required, with advance sample provisions and batch test reports. Bidder must provide OEM authorization and ISO 9001 certification. Delivery terms, shelf life, and packing standards are specified within the Terms. This is a government procurement opportunity with a broad medical device scope under ESIC’s health program in India. The tender emphasizes regulatory conformity, supplier capabilities, and traceable documentation through submission and delivery.

Technical Specifications & Requirements

• Product categories include: Ryles Tubes (12G/14G/18G), Stillet for intubation (10Fr), Non-Rebreather Mask (NRBM), Prostatic biopsy gun, and Syringes (1mL, fixed needle).
• Key dimensions and materials: Tube sizes (FG), length (cm ±5%), sterile PVC units, and needle sizes (G) for biopsy gun.
• Certifications required: MDR 2017 compliance, valid drug/medical device license under Drugs and Cosmetic Act, manufacturing unit certification, and batch test reports.
• Packing and shelf life: standard packing; minimum shelf life at delivery; total shelf life from manufacture to be specified.
• Advance sample: vendor must provide advance sample for buyer approval before supply commencement.
• Documentation: submission of all certifications, licenses, and MDR test reports at bid or with supplies.
• Quantity context: multiple line items with explicit counts for tubes, NRBM, needles, and syringes; OEM authorization required.
• Quality checks: material test certificate to accompany supply; buyer lab determines acceptance.
• Delivery scope: within ESIC procurement timeframe; compliance with delivery and packing requirements.
• Conformity to standard: all items must meet specified medical device conformity and safety norms.

Terms, Conditions & Eligibility

• EMD: amount not disclosed in tender data; bidders should expect standard security deposit procedures.
• Experience: ISO 9001 certification required; OEM authorization certificate mandatory.
• Licensing: MDR 2017 compliance; valid drug/medical device license under Drugs and Cosmetic Act.
• Documentation: provide MDR certificates, manufacturing unit certification, and test reports for each batch; advance samples may be required.
• Delivery & penalties: standard delivery schedule with potential penalties for non-compliance; option clauses allow quantity variation up to 25% and delivery time adjustments per contract terms.
• Warranty/acceptance: material test certificate and buyer lab results govern acceptance; adherence to packing and shelf-life requirements essential.
• Eligibility: bid submission must include OEM authorization, IS 9001 compliance, and all required licenses; ensure availability of test reports for each supplied batch.