Tender Overview
The procurement by the Municipal Corporation of Delhi targets Blood Collection Tubes and Blood Collection Needles focusing on MDR 2017 compliance, valid medical device licenses, and batch test reports. The scope includes advanced samples for buyer approval, minimum shelf life requirements, and supplier certifications. Location is Delhi, with emphasis on safety, leakproof construction, and identification labeling. The contract allows option quantity variations, and requires advance sample submission post-award. The bid emphasizes regulator compliance, batch testing, and manufacturer certification to ensure patient safety and traceability.
Technical Specifications & Requirements
- Product category: Blood collection tubes and needles; sterile, non-toxic, leakproof, crack-resistant material with transparency.
- Tube features: Negative air pressure inside, specified draw volume, cap color, graduation markings, and label for patient identification.
- Needle features: Needle length and size, material, type, and integrated safety shield; rubber sheath and dual-ended pointed design.
- Documentation: MDR 2017 compliance, valid medical device license under Drugs and Cosmetics Act, batch test reports for each supply, and supplier certifications.
- Shelf life: Minimum shelf life at delivery; advance samples to be provided for approval before supply.
- Packaging: Appropriate packing; advance sample submission after contract award.
Terms, Conditions & Eligibility
- EMD: Amount not disclosed in available data; ensure submission as per terms.
- Licenses & Certifications: MDR compliance, valid medical device license, manufacturer certification, batch test reports for each product.
- Delivery & Payment: Delivery timelines aligned with option clause up to 25% quantity variation; payment terms as specified in buyer terms.
- Workplace safety: Compliance with workman compensation and general insurance; safety protocols for handling medical devices.
- Submission requirements: All certifications, licenses, test reports at bid submission or along with supplies per buyer requirement.