Medical Health and Family Welfare Department Uttar Pradesh Unnao rapid test kits procurement 2026 - IS 1940 MDR 2017 compliant

Tender Overview

Medical Health and Family Welfare Department Uttar Pradesh invites bids for a diverse range of diagnostic consumables and allied items in Unnao, Uttar Pradesh. Procurements include Rapid Pregnancy Test Kits, Urine Test Strips, Point of Care Rapid Tests for Dengue, Malaria, Typhoid and other diseases, HIV/Syphilis/HBV/HCV kits, Universal Pipette Tips, Single Use Sterile Hypodermic Syringes conforming to IS 10258 (Part 1), and Blood Lancets. Estimated contract value is ₹5,524,875 with an EMD of ₹55,249. The scope is strictly “Supply of Goods” with no services; delivery terms will follow a flexible option clause allowing up to 25% quantity variation at contracted rates. The tender emphasizes compliance with Indian medical device regulations and licensing, and requires OEM turnover considerations for bid evaluation. The presence of multiple test kit types and accessories indicates a broad catalog and strict quality controls to meet public health needs. This opportunity targets suppliers capable of supplying ISI/ MDR-compliant medical devices and calibrated diagnostic consumables to government facilities.

Technical Specifications & Requirements

• Standards & Certifications: Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; valid Medical Device license from competent authority.
• Product Types: Rapid Test Kits (various diseases), Urine Test Strips, Universal Pipette Tips, Single Use Sterile Hypodermic Syringes (IS 10258 Part 1), Blood Lancets.
• Test Kit Details: Type of test kit, sample type, result time, Sensitivity (%), Specificity (%), positive/negative controls included per pack.
• Packaging & Materials: Number of tests per pack; material of strips; pipette tip volume (µL); needle included where applicable; packaging medium and number of tips per bag/box.
• Quality & Testing: Residual shelf life and testing parameters; certificates demonstrating compliance to relevant standards; brand/oem-specific requirements as described in terms.
• Delivery Scope: Only supply of goods with potential quantity variation up to 25% during procurement or currency; delivery period aligned to original delivery schedule with option extension; escalation matrix for service support.
• Documentation & Licensing: Availability of medical device license; documentation to support product specifications and sample/test data; supplier must demonstrate turnover and OEM qualifications.

Terms, Conditions & Eligibility

• EMD: ₹55,249 (as specified in bid terms).
• Turnover: Minimum average annual turnover for last 3 years as per bid document; OEM turnover criteria similarly specified; audited balance sheets or CA certificate required.
• Delivery & Payment: Delivery period linked to final delivery order; scope is strictly supply of goods; no service components; payment terms defined in terms; escalation arrangements for service support.
• Documents: GST registration, PAN, experience certificates, financial statements, EMD receipt, technical bid/compliance certificates, OEM authorizations as applicable; turnover evidence for last 3 years.
• Warranty & Penalties: Warranty provisions and LD/penalties if specified in buyer terms; option clause allows delivery extension under certain conditions.
• Other: OEM-related turnover compliance, dedicated service support number, and escalation matrix for post-sale support.