Employees State Insurance Corporation Blood Collection Needles Tender Kollam Kerala 2026 MDR 2017 Compliant

Tender Overview

The Employees State Insurance Corporation (ESIC) invites bids for Blood Collection Needles in Kollam, Kerala with an estimated value of ₹200,000. The procurement emphasizes a 22G, 25mm flash-back needle (black variant) and requires data on sterility, packaging, and shelf life. Key differentiators include adherence to MDR 2017, valid drug licensing under the Drugs and Cosmetics Act, and mandatory test reports for each batch. An advance sample provision is required for buyer approval prior to supply. This tender targets suppliers capable of meeting medical-device standards and providing complete certification documentation.

Technical Specifications & Requirements

• Needle size: 22G; Needle length: 25mm.
• Needle features: type of needle; pointed at both ends; rubber sheath over posterior needle.
• Material & Construction: specific material details not listed; ensure device meets general medical safety.
• Packaging: specify Type of Packing; ensure tamper-evident packaging and sterility maintenance.
• Certifications & Reports: must comply with MDR 2017; provide valid drug license under Drugs and Cosmetic Act; manufacturing unit certification; supply test reports as per MDR for every batch; submit all certifications with bid or along with delivery.
• Shelf Life: minimum shelf life required at delivery; advance sample for buyer approval before bid execution.
• BOQ/Items: No BOQ items published; core scope is single-product procurement with option clauses.
• When submitting, include evidence of MDR compliance, ISI-like or ISO references if applicable, and batch test documentation.

Terms, Conditions & Eligibility

• Option clause allows ±25% quantity variations at contract and during currency with adjusted delivery timelines; base delivery starts after last date of original order.
• Advance sample required for buyer approval prior to commencement of supply.
• Documentation: submit MDR compliance certificates, drug-licence under the Drug and Cosmetic Act, manufacturing unit certification, and batch test reports at bid time or with supplies.
• Quantity flexibility and compliance requirements demand readiness to adapt to extended delivery periods given the option clause.
• EMD/Financials: no explicit EMD amount stated in available data; ensure readiness to comply with typical ESIC bid submissions and payment terms.
• Delivery readiness and supplier capability to meet MDR and licensing prerequisites are essential.