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, 12:48 pm
Bid End Date
05-Mar-2026, 1:00 pm
Progress
Quantity
5
Bid Type
Two Packet Bid
The Employees State Insurance Corporation (ESIC) invites bids for the procurement of surgical sutures under the PRODUCT INFORMATION category, focusing on sterility, suture material, construction, size, and packaging details. Deliverables are restricted to supply of goods with required samples approved prior to bulk manufacturing. The scope includes compliance with medical device regulations and licensing, ensuring a ready-to-use, clinically acceptable suture set. Key differentiators include mandatory Material Test Certificates and supplier readiness to meet sample approval timelines. The tender emphasizes regulatory conformity and traceability within India, and places emphasis on quality control through buyer lab verification. The opportunity is anchored in ESIC’s procurement for medical consumables and aligns with health-sector supply continuity.
Product category: Surgical sutures with sterility and medical-grade material
Suture length: standard length with ±2 cm tolerance
Needle: included, with specified needle length tolerance ±0.5 mm and curved needle shape
Suture size and construction details to be provided in technical bid
Shelf life: specify residual shelf life requirements
Certifications: Drugs and Cosmetic Act 1940, MDR 2017 compliance; valid Medical Device license
Documentation: Material Test Certificate to accompany shipment; lab-based acceptance
Option quantity up to 25% of bid quantity during contract and currency
Two advance samples for buyer approval within 5 days of award
Buyer lab will determine acceptance; non-conforming samples may trigger contract termination
Delivery period aligned to original order date; extended delivery based on option clause
Only supply of goods; sample-related costs borne by seller unless otherwise specified
Not specified in available data; bidders should refer to standard ESIC terms for payment upon acceptance
Delivery commencement from last date of original delivery order; extended time formula applies with minimum 30 days
Not specified; contract may include LDs as per purchaser terms following acceptance and delivery milestones
Demonstrated experience in supplying surgical sutures and related medical devices
Valid medical device license and compliance with MDR 2017
Ability to provide Material Test Certificates and comply with buyer lab acceptance
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
Loading results...
| 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 | 3-0 |
| 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) | 20 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 |
Discover companies most likely to bid on this tender
GST registration certificate
Permanent Account Number (PAN) card
Experience certificates for similar surgical sutures procurement
Financial statements or turnover evidence
EMD/Security deposit documentation (as applicable by ESIC terms)
Technical bid documents demonstrating compliance with MDR 2017
OEM authorization letters (if bidding on behalf of the manufacturer)
Medical Device license validity proof from competent authority
Material Test Certificate to accompany delivery
To bid, register with ESIC portal, ensure MDR 2017 compliance and Drugs Act standards, obtain valid Medical Device license, and prepare GST, PAN, experience certificates, financial statements, and Material Test Certificate. Deliver two advance samples within 5 days of award for buyer approval.
Submit GST, PAN, experience certificates for similar supply, financial statements, EMD proof, technical bid, OEM authorizations if applicable, and a valid Medical Device license. Include Material Test Certificate with shipment in line with buyer lab acceptance.
Sutures must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, and hold a valid Medical Device license. Packaging and sterility must align with medical-grade requirements and be verifiable via Material Test Certificate.
The purchaser may increase or decrease the bid quantity by up to 25% at contract placement and during currency. Delivery time adjusts based on the original period, with a minimum 30 days for extended quantities.
Two advance samples must be submitted within 5 days of award. Buyer will approve or list modifications within 5 days; bulk supply must follow the approved sample specifications.
Acceptance is determined by the buyer’s lab results. Materials must pass Material Test Certificate tests; deviations may lead to termination or requirement of new samples before bulk supply.
Eligibility requires medical device licensing, MDR 2017 compliance, demonstrated supply of surgical sutures, ability to provide required certifications, and the capacity to meet sample approval timelines and delivery obligations.
Delivery begins after the last date of the original delivery order. If quantities increase, the extended period is calculated and may extend up to the original delivery timeline, with a minimum 30 days for addition.
Employees State Insurance Corporation
Employees State Insurance Corporation (esic)
📍 CHENNAI, TAMIL NADU
Sign up now to access all documents
Main Document
CATALOG Specification
GEM_GENERAL_TERMS_AND_CONDITIONS