Tender Overview
Organization: Bharat Heavy Electricals Limited (BHEL) – Department of Heavy Industry. Product: Intravenous Cannula (IV Cannula) with three-way stopcock integration, latex-free, non-toxic, pyrogen-free, and radio-opaque line. Location: India (general). Estimated value and EMD: not specified in available data. The tender emphasizes MDR 2017 compliance, medical device licensing under the Drugs and Cosmetic Act, and batch-specific test reports. Unique requirements include advance sample approval, two samples within 7 days of award, and potential delivery schedule adjustments if the buyer delays approval. The procurement emphasizes strict conformity to IS/ISO 10555-5 color coding, transparent flashback chamber, and integrity features for needle safety. The contract requires all certifications and test reports to be provided at bid submission or with supply.
Technical Specifications & Requirements
- Product features: Medical-grade needle material, latex-free, non-toxic and non-pyrogenic construction; integrated 3-way stop cock; luer lock plug/cap; winged design; vent fitting; transparent flashback chamber for blood detection; high visibility radio-opaque line; color coding as per IS/ISO 10555-5; needs to be compatible with standard IV administration protocols.
- Certifications & standards: MDR 2017 compliance; valid medical device license under Drugs and Cosmetic Act; manufacturer certification; batch-wise test reports per MDR; sample submissions with bid and/or supply; shelf life and minimum shelf life at delivery.
- Packaging & branding: Type of packing unspecified beyond standard medical device packaging expectations; advance sample approval required before bulk manufacture.
- Quality & testing: all required certifications, licenses, and test reports must be provided; advance samples must be approved or modified per buyer feedback within seven days of receipt of samples.
Terms, Conditions & Eligibility
- Advance samples: 2 samples within 7 days of award; buyer approves or lists modifications within 7 days; bulk supply aligned to approved sample.
- Invoice & GST: GST invoice and GST portal payment confirmation required on GeM portal during invoice generation.
- Delivery & LD: If buyer delays sample approval, delivery period may be re-fixed with no liquidated damages for the delay period; penalties apply if deviations are found post-sample.
- Documentation: Submit GST certificate, PAN, experience certificates, financial statements, EMD documentation, OEM authorizations, and all required technical certifications.
- Shelf life & testing: minimum shelf life at delivery; tests per MDR for each batch.
