North Eastern Railway Surgical Sutures Tender Lucknow UP - MDR 2017 Compliance, Medical Device License 2026
North Eastern Railway
GORAKHPUR, UTTAR PRADESH
Bid Publish Date
23-Feb-2026, 12:31 pm
Bid End Date
05-Mar-2026, 1:00 pm
Progress
Quantity
10
Bid Type
Two Packet Bid
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.
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
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
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 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
Not explicitly stated; sample approval and conformity requirements could trigger contract termination or modification
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
Main Document
CATALOG Specification
GEM_GENERAL_TERMS_AND_CONDITIONS
North Eastern Railway
GORAKHPUR, UTTAR PRADESH
North Eastern Railway
VARANASI, UTTAR PRADESH
Bharat Heavy Electricals Limited (bhel)
BHOPAL, MADHYA PRADESH
Bharat Heavy Electricals Limited (bhel)
BHOPAL, MADHYA PRADESH
Employees State Insurance Corporation
Tender Results
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| 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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GST registration certificate
PAN card
Experience certificates for supply of surgical sutures or similar medical devices
Financial statements or solvency documents
EMD/Security deposit proof (as applicable)
Technical bid documents demonstrating compliance with MDR 2017 and Drug Act 1940
OEM authorizations or approvals for medical devices
Material Test Certificate framework/sample approval documentation
Medical Device license validity and related certifications
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.
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.
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.
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.
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.
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.
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.
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.
Employees State Insurance Corporation
Employees State Insurance Corporation (esic)
📍 CHENNAI, TAMIL NADU
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Main Document
CATALOG Specification
GEM_GENERAL_TERMS_AND_CONDITIONS