Gujarat Health & Family Welfare Department Haematology Analyzer Reagents Tender Surat Gujarat 2026 MDR Compliance

Tender Overview

The Gujarat Health & Family Welfare Department invites a supply-only tender for Haematology Analyzer Reagents, located in SURAT, GUJARAT. The scope is limited to Supply of Goods with no BOQ items disclosed. Key compliance includes Drugs & Cosmetics Act 1940 and Medical Device Rules (MDR) 2017 adherence, plus a valid Medical Device license. The tender emphasizes quantity flexibilities up to 25% and requires initial Drawing approvals post-award, with potential delivery timeline adjustments if drawings are delayed. No estimated value is disclosed. This opportunity targets suppliers with MDR-compliant reagents and licensed products, seeking to participate in a state health procurement.

Technical Specifications & Requirements

• Product information: Reactivity, Type of Reagent, and Total Volume of Reagent per Pack must be defined by the supplier.
• Certifications: Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; possession of a valid Medical Device license issued by the competent authority.
• Packaging & handling: Reagent packaging details and pack volumes to be specified; ensure stability and compatibility with hematology analyzers.
• Delivery/Design linkage: After contract award, submit Detailed Design Drawings within 5 days for buyer approval; approval or list of modifications provided within 5 days; modifications must align with approved drawings; extended delivery time if drawings delayed.
• GST considerations: GST to be checked by bidders; reimbursement at actuals or applicable rates, capped to quoted GST percentage.

Terms, Conditions & Eligibility

• EMD/Security: Not disclosed in data; bidders should review terms for exact deposit requirements.
• Option clause: Purchaser may increase/decrease quantity up to 25% of bid/contract quantity during placement and currency; delivery period adjusted accordingly with formula provided.
• Scope & payments: Scope is supply of Goods; GST handling per actuals; payments governed by standard procurement terms; GST consequences not responsibility of Purchaser.
• Delivery & approvals: Delivery timeline linked to drawing approvals; non-approval by Buyer may extend delivery period without LD; ensure readiness to supply post-approval.
• Documentation: Prepare requisite technical and regulatory documentation to meet MDR and device-license prerequisites; maintain compliance throughout contract.