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Employees State Insurance Corporation Surgical Sutures Tender 2026 Maharashtra India MDR 2017 IS 1943-compliant

Bid Publish Date

23-Feb-2026, 12:31 pm

Bid End Date

05-Mar-2026, 1:00 pm

Progress

Issue23-Feb-2026, 12:31 pm
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

10

Bid Type

Two Packet Bid

Categories 1

Tender Overview

Organization: Employees State Insurance Corporation; Product: Surgical sutures (Sterile, medical grade) including suture material/construction/size with needle details; Location: India (national procurement, ESIC) and related healthcare facilities; Estimated Value: not disclosed; Delivery: to be aligned with contract terms; Scope: supply of goods only, with sample approvals required post-award; emphasis on regulatory compliance and sterility; unique aspects include a flexible quantity option up to 25% and mandatory Material Test Certificate with each supply.

Technical Specifications & Requirements

  • Category: PRODUCT INFORMATION – Sterility, Type of Suture, Suture Material (Medical Grade), Suture Construction, Suture Size, Suture Length (±2cm), Needle included, Needle Length (±0.5mm), Needle Shape (Curvature)
  • Packing: Number of Strands per Pack; Shelf Life: Residual shelf life consideration
  • Certifications: Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; Validity of Medical Device license from competent authority
  • Quality/Testing: Include Material Test Certificate; supply checked by Buyer’s Lab; acceptance based on lab results; advance sample approval within contract framework; failure to conform may trigger deviations or termination
  • Notes: No BOQ items available; procurement is strictly supply of goods with mandatory testing and regulatory compliance

Terms, Conditions & Eligibility

  • EMD/Payment Terms: Not disclosed in data; contract allows 25% quantity variation during execution; delivery timeline extends from last delivery order date; no LD clauses specified here
  • Delivery: Delivery period calculated post original/extended delivery dates; additional time formula provided; no specific delivery window given
  • Documentation: Material Test Certificate to be submitted with supply; advance sample approval process requires two samples within 5 days of award; bulk supply must adhere to approved sample
  • Eligibility: Supplier must comply with MDR 2017 and Drug Act provisions; valid Medical Device license essential; scope limited to goods supply; compliance with contractual sample approvals is mandatory

Key Specifications

  • Sterility: sterile surgical sutures

  • Type of Suture: specify needle and suture pairing

  • Suture Material (Medical Grade): compliant with medical device norms

  • Suture Construction: applicable construction type per product

  • Suture Size: exact gauge/diameter per item

  • Suture Length: within ±2 cm of stated length

  • Needle included: yes, with defined Needle Length ±0.5 mm and Curve shape

  • Needle Shape: defined curvature specification

  • Number of Strands per Pack: packaging detail

  • Residual shelf life: minimum remaining shelf life criteria

  • Certifications: MDR 2017 compliance; Drugs and Cosmetic Act 1940 compliance

  • Medicine Device License: valid license from competent authority

Terms & Conditions

  • 25% quantity variation allowed at contract placement and during contract currency

  • Advance sample approval required within 5 days of award; 2 samples to be submitted

  • Material Test Certificate to accompany supply; lab results govern acceptance

  • Only supply of goods; sample-based approval governs bulk manufacturing

  • Delivery periods defined by original and extended timelines with potential formula

Important Clauses

Payment Terms

Not specified; scope covers only supply of goods with potential 25% quantity variation at the time of order and during contract currency at contracted rates

Delivery Schedule

Delivery period starts from last date of original delivery order; additional time calculated as (Increased quantity ÷ Original quantity) × Original delivery period with a minimum 30 days

Penalties/Liquidated Damages

Not explicitly stated; sample approval and conformity requirements could trigger contract termination or modification

Bidder Eligibility

  • Sufficient experience in supplying surgical sutures or sterile medical devices

  • Valid GST registration and compliance with MDR 2017 and Drugs and Cosmetic Act 1940

  • Valid Medical Device license from competent authority

Documents 3

GeM-Bidding-9029763.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Sterility Sterile
PRODUCT INFORMATION Type of Suture Absorbable
PRODUCT INFORMATION Suture Material (Medical Grade) Polydioxanone
PRODUCT INFORMATION Suture Construction Mono-filament
PRODUCT INFORMATION Suture Size 2-0
PRODUCT INFORMATION Suture Length (±2cm) 70 cm
PRODUCT INFORMATION Needle included Single Arm Needle
PRODUCT INFORMATION Type of Needle Round Bodied
PRODUCT INFORMATION Needle Length of each arm (±0.5mm) 30 mm
PRODUCT INFORMATION Needle Shape (Curvature) 1/2 circle
PACKING Number of Strands per Pack 12
SHELF LIFE Residual shelf life of the product Agree to provide residual shelf life of atleast 75% of total shelf life at the time of delivery to the consignee
CERTIFICATIONS Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS Availability of valid Medical Device license for the product issued from the competent authority Yes

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates for supply of surgical sutures or similar medical devices

4

Financial statements or solvency documents

5

EMD/Security deposit proof (as applicable)

6

Technical bid documents demonstrating compliance with MDR 2017 and Drug Act 1940

7

OEM authorizations or approvals for medical devices

8

Material Test Certificate framework/sample approval documentation

9

Medical Device license validity and related certifications

Frequently Asked Questions

How to bid for the ESIC surgical sutures tender in India 2026

Bidders should submit GST registration, PAN, experience certificates for medical devices, financial statements, and EMD proof if applicable. Ensure MDR 2017 and Drugs and Cosmetic Act 1940 compliance, plus valid Medical Device license. Prepare two advance samples within 5 days of award for buyer approval.

What documents are required for ESIC sutures procurement in India

Required documents include GST certificate, PAN Card, experience certificates for sutures, financial statements, EMD proof, OEM authorizations, and Material Test Certificates; ensure MDR 2017 compliance and valid Medical Device license; supplier must provide advance sample documentation.

What are the technical specifications for ESIC sutures in this tender

Specifications cover sterility, type of suture, medical-grade material, construction, size, length within ±2 cm, needle included with length ±0.5 mm and curvature, and packing strands per pack; residual shelf life must meet regulatory expectations; compliance with MDR 2017 and Drugs Act 1940 is mandatory.

When is the ESIC advance sample submission for sutures due

Two advance samples must be submitted within 5 days of contract award; buyer may provide modifications within 5 days; if buyers delay, delivery period is adjusted; bulk supply must conform to approved sample framework.

What is the scope of supply for the ESIC sutures tender

Scope is strictly the supply of goods; option for quantity variation up to 25% either at contract award or during the contract period; delivery timeline linked to last delivery order date with calculated extensions.

What certifications and licenses are required for ESIC suture tender

Suppliers must demonstrate compliance with Drugs and Cosmetic Act 1940 and MDR 2017, and present a valid Medical Device license from the competent authority; material test certificates should accompany deliveries.

What is the quality acceptance process for ESIC sutures

Buyer’s lab will test supplied material; acceptance hinges on lab results; failure to conform can lead to approvals for modification or contract termination per supplier deviation notices.

What is the delivery period calculation for ESIC sutures

Delivery time extends from the last date of the original delivery order; additional time equals (Increased quantity ÷ Original quantity) × Original delivery period, with a minimum of 30 days; extended periods may apply during option execution.

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