Employees State Insurance Corporation HIV/Syphilis/HBV/HCV Rapid Test Kit Tender Gurgaon Haryana 2026 MDR 2017 Compliant

Tender Overview

Employees State Insurance Corporation (ESIC) in Gurgaon, Haryana seeks Rapid Test Kit for HIV / Syphilis / HBV / HCV. Estimated EMD is ₹24,000 with strict data-sheet verification. Bidders must ensure MDR 2017 compliance and valid Medical Device license. Each pack should include positive and negative controls and specify number of tests per pack. Experience criterion requires supplier familiarity with similar government procurement for 3 years and OEM authorization. A mandatory data sheet upload will be cross-checked against product specs. Shelf life minimum 2 years with at least 50% usable life on delivery. An advance sample approval is required within 5 days of award, with modification lists delivered within 5 days if needed. This tender emphasizes strict quality verification and data-sheet alignment with product parameters.

Key differentiators include: explicit drug regulatory compliance, OEM authorization, and advance-sample workflow to ensure conformity before bulk manufacture. Unique aspect is the cross-check between supplied data sheets and actual kit specifications for HIV/HBV/HCV/Syphilis rapid testing in a public health setting.

Keywords: tender in Gurgaon, ESIC procurement, rapid test kit, HIV HIV test kit, MDR 2017 compliant, medical device license, data sheet upload.

Technical Specifications & Requirements

• Product information: Type of Test Kit; Result Time: as specified by kit; Number of tests per pack; Positive and negative controls provided with each pack.
• Certifications: Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; Availability of valid Medical Device license issued by competent authority.
• Product information repeat: Type of Test Kit; Result Time; Positive/negative controls; Packaging; Certification compliance.
• Section reiterates that the product must be IS/ MDR-compliant with 2-year shelf life and minimum 50% usable shelf life on delivery.
• Documentation alignment: Data Sheet of the product offered must be uploaded and match the product specifications.

Terms & Eligibility

• EMD: ₹24,000 (as per tender) and payable as specified by ESIC; data-sheet alignment mandatory.
• Experience: Bidder or OEM must have regularly manufactured and supplied same/similar Category Products to Central/State Govt/PSU for at least 3 years prior to bid opening; submit relevant contracts.
• Manufacturer Authorization: If using distributors, provide OEM authorization with full details.
• Shelf Life: Minimum 2 years shelf life; at delivery, at least 50% usable life remaining.
• Advance Sample: Submit advance samples within 5 days of award; buyer to approve or specify modifications within 5 days.
• Additional: 25% quantity variation rights, extension of delivery as per option clause, and data-sheet verification mandatory.