Gujarat Health & Family Welfare Department Haematology Analyzer Reagents Tender NAVSARI Gujarat 2026 MDR 2017

Bidders must meet regulatory requirements, provide Medical Device licenses, and submit technical compliance with reagents types, packaging, and shelf life. Include OEM authorizations, GST, PAN, financials, and experience certificates. The tender allows ±25% quantity variation and requires alignment with MDR 2017 and Drugs and Cosmetics Act.

Submit GST certificate, PAN, recent financial statements, experience certificates in hematology reagent supply, OEM authorization, technical compliance documents, and current Medical Device license for the product. Include any regulatory endorsements proving MDR 2017 compliance and actuator of packaging and shelf life specifics.

Reagents must comply with Drug and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, with a valid Medical Device license from the competent authority. Attach license number, issue, and expiry dates, plus product-specific compliance certificates demonstrating regulatory readiness.

The purchaser may adjust quantity by up to 25% of bid quantity at contract placement and during the currency at contracted rates. Delivery timing follows a formula with a minimum extension of 30 days if increased quantities are ordered.

Delivery starts after the original delivery order; extension calculations are (Increased quantity ÷ Original quantity) × Original delivery period, with a minimum of 30 days and potential extension to the original period as per option clause.

Essential approvals include MDR 2017 compliance and a current Medical Device license for the reagent product. Bidders should also demonstrate adherence to Drugs and Cosmetics Act requirements and provide regulatory documentation with bid submission.

Provide explicit sample compatibility details (e.g., compatible with whole blood, plasma) and reagent form (liquid/lyophilized). Include packaging, total pack volume, and shelf life to ensure alignment with lab analyzer requirements and NAVSARI delivery needs.

No BOQ items are listed in the data; bidders should anticipate a broad reagent category under Haematology Analyzer Reagents and prepare for multiple SKUs meeting regulatory standards and packaging requirements.