ESIC Tender for Single Use Sterile Rubber Surgical Gloves IS 13422 Q2 - MDR 2017 Compliance 2026

Tender Overview

Organization: Employees State Insurance Corporation (ESIC). Product: Single Use Sterile Rubber Surgical Gloves conforming to IS 13422 (Q2). Category: Medical device consumables; gloves packaging details include number of pairs per pack. Location: India (nationwide tender context implied by ESIC procurement). Estimated value and EMD: not disclosed in the summary data; bidders should verify in the procurement portal. Unique differentiator includes mandatory regulatory alignment with Drug and Cosmetic Act 1940, Medical Device Rules (MDR) 2017 amendments, and obtaining a valid Medical Device license from the competent authority. This tender requires OEM authorization and CDSCO/MDR licensing compliance. The absence of BOQ items suggests procurement scope spans standard glove specifications rather than a fixed quantity. This opportunity emphasizes compliance, licensing, and packaging standards as critical decision levers for suppliers.

Technical Specifications & Requirements

• Product information: Gloves with specified material, finish, design, cuff termination, and glove size options; packaging details indicate fixed pairs per pack (exact numbers not provided).
• Certifications/Regulatory: Must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017; possess a valid Medical Device license from the competent authority; optionally include BIS/ISO certifications; provide CDSCO/MDR Licence and Trade Licence.
• Documentation cue: OEM authorization, specification compliance, and Aadhar/GST/PAN documents are required for bid submission.

Terms, Conditions & Eligibility

• EMD/Performance: EMD not disclosed; bidders should be prepared to submit an EMD as per ESIC terms and any performance security.
• Delivery/ATC: The Buyer reserves the right to adjust quantity up to 25% of bid quantity; delivery timelines align with original or extended periods as described in the ATC.
• Submission: Include specification compliance, OEM authorization, GST/PAN, experience, BIS/ISO, EMD/EPBG, MSME/Start-up status, MII Declaration, OEM/Distributor ATC, signed bid, and licenses (CDSCO/MDR).