Employees State Insurance Corporation Biochemistry Reagent Kit Tender India 2025 – IS 1940 MDR 2017 Compliance

Tender Overview

The bid opportunity is issued by Employees State Insurance Corporation for the procurement of a Biochemistry Reagent Kit for Human Samples (Q2, PAC only). The bundle covers product components such as reagents with calibrators and controls, with packaging details including total volume per pack and form of reagent at supply. Key certifications include Drugs and Cosmetics Act 1940 and Medical Device Rules (MDR) 2017 compliance, plus a valid Medical Device license and traceability certificate for calibrators. The package requires Data Sheets and an Integrity Pact, with OEM authorization if applicable. This procurement emphasizes regulatory compliance and supply chain integrity, with emphasis on data sheet alignment and cross-verification against product specifications. Tender involves documented supplier integrity and adherence to QA documentation, ensuring traceability and regulatory alignment for central/state government supply. This opportunity is relevant for suppliers with established govt supply experience and access to compliant reagents, calibrators, and controls in the biochemistry domain.

Technical Specifications & Requirements

• Product category: Biochemistry reagent kit for human samples
• Supported sample type: Not specified in detail
• Type of test: Not specified in detail
• Form of reagent: Supplying form per kit (as applicable)
• Calibrator/Control: Calibrator and control provided with each pack
• Total volume per pack: Not disclosed
• Certifications: Drugs and Cosmetic Act 1940, MDR 2017 as amended, valid Medical Device license, Traceability certificate with calibrators
• Data requirement: Upload Data Sheet; ensure technical parameter alignment; mismatch may lead to bid rejection
• Compliance/OEM: Manufacturer authorization where distributors bid; integrity pact mandatory
• Bid option clause: Quantity may vary ±25% with corresponding delivery time adjustments; minimum extension 30 days
• Delivery/contract mechanics: Delivery starts after last date of original order; option clause governs extended delivery periods
• Other: No BOQ items; scope hinges on regulatory-compliant reagent kits and associated paperwork

Terms, Conditions & Eligibility

• Option clause: Purchaser may increase/decrease quantity by 25%, with delivery time recalculated; minimum extension 30 days; adjustments apply to contracted rates
• Integrity Pact: Bidder must upload signed integrity pact as per buyer policy
• Data Sheet: Mandatory data sheet submission; must match product specifications
• Experience: Bidder or OEM must have regularly manufactured/supplied similar Category Products to Central/State Govt/OUs for at least 1 year prior to bid opening; provide contracts
• Authorization: OEM/service provider authorization form required with bid
• Financial standing: Bidder must avoid liquidation or bankruptcy; an undertaking must be uploaded
• Contractual liability: Seller cannot assign or wholly/sub-contract without buyer consent; joint and several liability retained