Gujarat Health & Family Welfare Haematology Analyzer Reagents Tender Navsari 2026 MDR-2017

Tender Overview

Health & Family Welfare Department Gujarat invites suppliers for haematology analyzer reagents (V2) in NAVSARI, GUJARAT 396040. The procurement focuses on reagents supporting hematology analyzers with specified sample reactivity and reagent form, including packaging and shelf life details. Key compliance demands include Drugs and Cosmetic Act 1940 and MDR 2017 adherence, and a valid Medical Device license with traceability certificates for calibrators. A 25% quantity adjustment right is reserved, with delivery timelines linked to the original delivery order. This opportunity targets vendors with proven regulatory compliance and calibration traceability capabilities, emphasizing quality control and market-relevant certifications.

Key differentiators include regulatory alignment (MDR 2017) and traceability certification for calibrators, ensuring product integrity across hospital settings. The absence of BOQ items suggests a reagents-focused scope with potential variability in itemization. The tender’s structure implies a flexible quantity mechanism to accommodate shifting demand while maintaining contracted rates.

Technical Specifications & Requirements

• Category: PRODUCT INFORMATION – Supported sample type, reactivity,/type of reagent, reagent form
• Category: PACKAGING – Total volume per pack
• Category: SHELF LIFE – Residual shelf life of the product
• Category: CERTIFICATIONS & REPORTS – Compliance to Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license; traceability certificate with calibrators
• Quality controls: Traceability and calibrator documentation required; MDR 2017 compliance mandatory
• Regulatory scope: Medical device licensing and drug regulation alignment for reagents
• Delivery/quantities: 25% quantity variation allowed; delivery schedule tied to original/extended orders
• EMD/price: Not specified in data; likely required per standard procurement practice

Terms, Conditions & Eligibility

• Option Clause: Purchaser may increase/decrease quantity up to 25%; extended delivery time calculations apply with minimum 30 days
• Delivery: Starts from last date of original delivery order; extended periods follow option clause provisions
• Compliance: Reagents must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017; include valid Medical Device license and traceability certificates
• Documentation: Provide regulatory certificates and calibrator traceability proofs; bidder must meet standard pharma-regulatory requirements
• EMD: Not specified in available data; bidders should anticipate standard EMD as per state procurement norms
• BOQ: No items listed, indicating reagents-focused procurement rather than equipment or services