North Eastern Railway Nebulizer Mask Procurement Gorakhpur Uttar Pradesh 2017 MDR Compliance ISO 9001 Bid 2026

Tender Overview

North Eastern Railway invites bids for the supply of nebulizer masks to support hospital stores in Gorakhpur, Uttar Pradesh. The procurement specifies general product name and usage details, with required medical-grade material and size considerations. A valid medical device license under the Drugs and Cosmetic Act and MDR 2017 compliance are mandatory, alongside ISO 9001 certification from the bidder or OEM. The tender emphasizes supplier credibility through OEM authorization and pre- or post-receipt inspections, with the consignee being the MD/Surgical Store at Gorakhpur. The absence of a BOQ suggests item-level quantities are defined in the bid documents. This opportunity targets medical equipment suppliers with formal quality management systems and proven regulatory compliance, highlighting the importance of document readiness and certification alignment prior to bid submission.

Technical Specifications & Requirements

• Product category: Nebulizer masks with medical-grade material and appropriate size
• Sterility: Not explicitly stated; ensure masks meet medical-grade sterility expectations
• Material (Medical Grade): Required; supplier must confirm material composition
• Size: Must cover standard nebulizer mask dimensions suitable for medical use
• Certifications: Medical Device Rules (MDR) 2017 as amended; valid medical device license under Drugs and Cosmetic Act 1940; ISO 9001 certification for bidder or OEM
• Manufacturer Certification: Required; OEM authorization or manufacturer proof
• Inspection: Post-receipt inspection at consignee site; pre-dispatch inspection not specified
• Delivery/Submission: Advance sealed sample to Gorakhpur hospital address before bid opening; ensure all documents uploaded with bid

Terms, Conditions & Eligibility

• EMD/Deposit: Not specified in available data; bidders should verify in ATC and Corrigendum
• Experience/Turnover: ISO 9001 certification mandatory; no explicit year-of-experience stated beyond certification
• Delivery: Not explicitly defined; ensure readiness for timely delivery per tender terms
• Payment Terms: Not specified; bidders should confirm payment terms in the final bid
• Documents: GST registration, PAN, ISO 9001 certificate, MDR compliance proof, medical device license, OEM authorization, sample submission address
• Inspection: Post-receipt inspection at consignee site; pre-dispatch inspection not mandated
• Penalties/Warranty: Not disclosed in available data; verify in ATC for LD or warranty clauses