Indian Air Force Hemodialysis Catheter Kit Tender 2026 Maharashtra MDR 2017 ISO 9001

Tender Overview

The Indian Air Force invites bids for a Hemodialysis Catheter Kit under the Department of Military Affairs. Estimated value is ₹12,330. The scope covers sterile catheter components, dilators, guidewires, syringes, introducer needles, scalpel blades, caps, and surgical needles as per MDR 2017 rules. Key differentiators include mandatory MDR 2017 compliance and ISO 9001 certification, plus production and packaging integrity under medical device norms. This procurement targets reliable medical kits for clinical use within military medical stores. The tender emphasizes formal QC, pre/post inspection, and supplier adherence to safety and shelf-life requirements. Location details are not disclosed in the provided data, but procurement corresponds to government medical supply needs and cold chain considerations. The unique aspect is the combination of multiple kit components within a single medical device bundle and strict regulatory compliance expectations.

Technical Specifications & Requirements

• Product category: Hemodialysis catheter kit including catheter, dilators, guidewire, syringe, introducer needle, scalpel blade, caps, and surgical needle.
• Compliance: MDR 2017 as amended, ISO 9001 certification for bidder or OEM, BIS licence and type-test/approval certificates.
• Shelf life: Minimum shelf life of at least two years with stock replacement obligations per DGCI/MS rules.
• Testing: Samples tested at designated AHSP labs or govt/NABL labs; outside testing costs borne by seller. Post-receipt inspection by medical officers and Head of Department.
• Quality/Documentation: Mandatory certificates uploaded with bid; recalls and cold chain management obligations highlighted.
• ELIGIBILITY & DELIVERY: Inspection clauses, post-dispatch acceptance, and adherence to schedule in ATC terms; no pre-dispatch clause unless specified.

Terms, Conditions & Eligibility

• EMD: Not stated in data; ensure clarification before bid submission.
• Documentation: Upload MDR compliance, ISO 9001, BIS licenses, type tests, approval certificates, and other prescribed certificates.
• Inspection: Post-receipt inspection by medical authorities; pre-dispatch nil unless selected.
• Shelf life: Minimum two years with stock replacement six months prior to expiry if stock remains.
• Recall & cold chain: Supplier must notify buyer of recalls and maintain cold chain per DCGI/CDSO guidelines.
• Delivery & payment: Terms not fully specified; anticipate standard government terms to be confirmed during ATC.