Bharat Heavy Electricals Limited Rapid Pregnancy Test Kit Tender Haridwar Uttarakhand 2017 MDR Compliance 2026

Tender Overview

Bharat Heavy Electricals Limited (BHEL), located in Haridwar, Uttarakhand, invites bids for a Rapid Pregnancy Test Kit (Q2). The procurement involves a single category of product information with specifications for sample type, sensitivity, specificity, and pack quantity per unit. Certifications required include compliance with the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended, plus a valid Medical Device license from the competent authority. The tender emphasizes compliance, license validity, and packaging details, with no BOQ items published. The emphasis is on regulatory conformity and supplier readiness to deliver compliant tests in a defined quantity under BHEL terms.

Technical Specifications & Requirements

• Product category: Rapid pregnancy test kit
• Product information: Sample Type; Sensitivity; Specificity
• Packaging: Number of Tests per Pack
• Certifications: Drugs and Cosmetic Act 1940 and MDR 2017 compliance; valid Medical Device license from competent authority
• Regulatory alignment: required licenses and FDA-equivalent compliance not specified beyond MDR and licensing
• Quality & compliance focus: ensure MDR 2017 amendments, license validity, and packaging conformity for safe distribution
• Delivery expectations: not explicitly stated in BOQ, delivery terms governed by Buyer terms

Terms, Conditions & Eligibility

• EMD/FD: Not explicitly specified in data; adherence to BHEL terms and payment cadence will matter
• Payment terms: 100% payment within 45/60/90 days from material entry date, subject to non-discrepant documents and acceptance
• Contract risk control: 10% performance security encashment clause; remedies for breach, with possible suspension of business dealings for non-performance
• Compliance & ethics: strict avoidance of conflicts of interest; adhere to BHEL guidelines for supplier conduct
• Documentation: ensure provision of regulatory licenses and proof of MDR compliance, packaging specs, and test kit certifications
• Penalties: LDs and potential debarment for breach as per contract; ensure risk management with appropriate warranties