Gujarat Health & Family Welfare Department Haematology Analyzer Reagents for Erba H360 Tender 2026 Rajkot Gujarat

Bidders must register with the Gujarat Health & Family Welfare Department, obtain appropriate OEM authorization for Erba H360 reagents, and submit GST, PAN, Medical Device license, and quality data sheets. Ensure MDR 2017 and Drugs Act compliance; confirm reagent compatibility with Erba H360 and packaging specs. Delivery terms align with the 25% quantity variation clause.

Required documents include GST registration, PAN card, OEM authorization for Erba H360 reagents, Medical Device license, and product data sheets. Also include regulatory compliance certificates under Drugs and Cosmetic Act 1940 and MDR 2017, plus supplier experience certificates if available.

Reagents must be compatible with Erba H360, with defined reactivity and total pack volume. Compliance with MDR 2017 and Drugs Act 1940 is mandatory; a valid Medical Device license is required. Exact pack volumes and reagent types will be detailed in the technical bid data during submission.

Delivery windows operate on the last delivery order date, with the option to increase quantity up to 25% at contracted rates. If exercised during extended periods, the extra time is calculated as (additional quantity/original quantity) × original delivery period, minimum 30 days.

Mandatory compliance includes the Drugs and Cosmetic Act 1940 and MDR 2017, plus a valid Medical Device license. Reagents must be labeled, packaged biosafety-compliant, and accompanied by data sheets validating Erba H360 compatibility.

Prove eligibility with OEM authorization for Erba H360 reagents, Medical Device license, and regulatory compliance certificates. Provide verifiable experience in supplying similar reagents, plus GST and PAN documentation. The bid may require confirmation of reagent packaging and reactivity specifics.

Verify that your reagents meet MDR 2017 amendments and have a valid Medical Device license. Ensure labeling, safety data sheets, and packaging meet regulatory norms, and attach these documents to the bid. Compliance verification may be requested through technical bid submissions and audits.

The purchaser reserves the right to adjust quantities by up to 25% during contract placement and currency. The calculation for extended delivery after quantity changes uses the formula specified, with a minimum extension of 30 days, ensuring delivery timelines align with revised orders.