Tender Overview
Bharat Heavy Electricals Limited (BHEL) seeks procurement of intravenous cannula for the Department of Heavy Industry, to be supplied at Bhopal, Madhya Pradesh (462001). The tender emphasizes MDR 2017 compliance, medical device licensing under the Drugs and Cosmetic Act, and batch-wise test reports. The scope includes cannula components with three-way stopcock integration, latex-free, non-toxic materials, and transparent flashback chambers for blood visibility. Emphasis on color coding per IS/ISO 10555-5 and integration features like Luer Lock, vent fitting, and radiopaque line differentiates this requirement. Advance sample approval is mandated post-award, with potential delivery adjustments if approvals are delayed. Expected pharmaceutical-grade standards and adherence to buyer-specified packaging are core differentiators.
- Organization: Bharat Heavy Electricals Limited (BHEL)
- Product: Intravenous cannula (IV Cannula) with MDR 2017 compliance
- Location: Bhopal, Madhya Pradesh
- Category: Medical devices – IV cannula (Q2)
- Key differentiator: Mandatory advance sample approval, batch-wise test reports, IS/ISO 10555-5 color coding, and integrated three-way stopcock
- Unique aspects: Compliance with Medical Device Rules (MDR) 2017, valid medical device license under Drugs and Cosmetic Act, and supplier readiness for sample-based verification
Technical Specifications & Requirements
- Product/Service: Intravenous cannula with medical-grade needle, latex-free, non-toxic and non-pyrogenic materials
- Standards & Certifications: MDR 2017 compliance; valid medical device license under Drugs and Cosmetic Act 1940; batch-wise test reports per MDR 2017; IS/ISO 10555-5 color coding
- Key Features: Needle material compliant; integrated with three-way stopcock; Luer lock plug/cap; injection port; wings; radiopaque line; protective needle-stick safety; transparent flashback chamber
- Labeling & Packaging: Color coding per IS/ISO 10555-5; packaging type defined by buyer; shelf life from date of manufacture; minimum shelf life at delivery
- Documentation: Manufacturer certification; all required certifications, licenses, and test reports at bid submission and/or with supplies
- Advance Sample: 2 samples within 7 days post-award for buyer approval; modification list provided within 7 days; bulk supply aligned to approved sample
- Delivery & Quality: Deliver as per contract with conformity to standard, supply of test reports for each batch; non-conforming samples may trigger re-sampling or termination
Terms, Conditions & Eligibility
- EMD/Security: Not specified in data; bidders should expect standard EMD as per tender norms
- Experience & Licensing: Must hold MDR compliance; valid medical device license under Drugs and Cosmetic Act 1940; manufacturer certification
- Delivery & Payment: Advance approval of samples required; delivery schedule adjustable if sample approval is delayed; payment terms to be as per buyer contract
- Documents: GST invoice, GST payment confirmation, OEM authorizations, batch test reports, licenses, and certifications
- Quality & Warranty: Minimum shelf life at delivery; adherence to MDR 2017; test reports with every batch; samples provided free of cost for testing
- Penalties & Modifications: Non-conforming samples may lead to fresh samples or contract termination; LD terms not explicitly stated in data
- Shelf Life: Minimum shelf life defined as “minimum shelf life at delivery” from manufacture date
