Gujarat Panchayats And Rural Housing Department Sterile Hypodermic Syringes Tender Surendranagar 2026 IS 10258 MDR 2017

Tender Overview

The procurement opportunity is issued by the Gujarat Panchayats And Rural Housing Department for the supply of single-use sterile hypodermic syringes for human use, conforming to IS 10258 (Part 1), with a Q2 qualification. The tender requires EMD ₹28,500 and mandates compliance with the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, along with a valid Medical Device license. Location specified is Surendranagar, Gujarat 363001. The packaging and needle-inclusion requirements indicate emphasis on safe disposal features and needle protection caps or shields. The absence of BOQ items suggests itemized product sub-variants may be defined during evaluation. Bidder clarity hinges on regulatory compliance, licensing, and shelf-life considerations. The distinctive feature is alignment to essential medical device norms and human-use syringes under public procurement in Gujarat.

Technical Specifications & Requirements

• Product type: Single-use sterile hypodermic syringe with needle included; Needle cap/shield for safety.
• Nominal capacity: various/ml capacity as per project needs (noted as part of product family).
• Packaging: number of pieces per pack; residual shelf life required to be stated on packaging.
• Certifications: must comply with Drugs and Cosmetic Act 1940 and MDR 2017; must hold a valid Medical Device license from competent authority.
• Quality/standards: IS 10258 (Part 1) compliance; human-use medical device standards.
• Documentation: shelf life data, lot traceability, and licensing details to be provided.
• Lot/batch control: traceability to batches; end-user safety features mandated.

Terms, Conditions & Eligibility

• EMD: ₹28,500 (as stated)
• Regulatory compliance: Drugs and Cosmetic Act 1940; Medical Device Rules (MDR) 2017; valid Medical Device license
• Delivery expectations: clearly defined TBD by purchaser; ensure timely conformity with regulatory norms
• Documentation to submit: GST, PAN, medical device license, regulatory certificates, and product-spec data sheets
• Pre-qualification criteria: demonstration of capability to supply sterile syringes meeting IS 10258 (Part 1) and safety standards
• Warranty/aftercare: not specified; emphasis on compliance and traceability
• Penalties: not specified in provided data; subject to buyer terms on compliance