Rail Coach Factory Kapurthala Surgical Sutures Tender Kapurthala Punjab ISM & MDR 2017 Compliant 2026
Rail Coach Factory Kapurthala
KAPURTHALA, PUNJAB
Posted:
25 April 2026
Closed:
6 May 2026
GEM
GEM
Bharat Heavy Electricals Limited Surgical Sutures Tender 2026 India IS/Medical Device Compliance
Bid Publish Date
06-Jun-2026, 10:56 am
Bid End Date
16-Jun-2026, 2:00 pm
Location
BHOPAL , MADHYA PRADESH
Progress
Issue06-Jun-2026, 10:56 am
AwardPending
Quantity
20
Bid Type
Two Packet Bid
Key Highlights
- • Brand/OEM requirements: Not specified
- • Technical certifications: Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017; valid Medical Device license
- • Special clauses: Advance sample approval prior to bulk supply; 7-day window for submitting 2 samples; modification timeline
- • Eligibility: GST registration, ability to provide GST invoice and CRAC-based payment documentation
- • Warranty/AMC: Not specified in provided data
- • Penalties: Delivery schedule adjusted with no LD during buyer delay; potential contract termination for major deviations
- • Delivery/Installation: Advance sample approval before bulk manufacturing; 90-day payment after CRAC
- • Delivery terms: 90 days payment; online bill submission; 3 copies of tax invoices
- • Shelf life, packing, and needle parameters: Include packaging strands per pack, residual shelf life, needle length ±0.5mm, curvature
- • Regulatory: Sterility, medical-grade materials, and MDR-compliant product
Categories
1
Tender Overview
Bharat Heavy Electricals Limited (BHEL) invites bids for sterile surgical sutures under the Department of Heavy Industry framework. The procurement centers on medical-grade sutures with complete sterility, suture material, construction, size, length (±2cm), and needle parameters, including needle length (±0.5mm) and curvature. Packaging details specify the number of strands per pack, expected residual shelf life, and compliance to regulatory standards. The scope emphasizes certification readiness: compliance to the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, plus valid Medical Device license. The contract contemplates sample-based pre-approval and a 90-day payment cycle post CRAC, with GST-compliant invoicing in the GeM portal. Location is India, with a focus on procurement of surgical sutures, including packing and shelf-life requirements.
Technical Specifications & Requirements
- Sterility, Type of Suture, Suture Material (Medical Grade), Suture Construction, Suture Size, Suture Length (±2cm), Needle included, Needle Type, Needle Length (±0.5mm), Needle Shape (Curvature)
- Packing: Number of Strands per Pack; Shelf Life: Residual shelf life of the product
- Certifications: Compliance to Drugs and Cosmetic Act 1940 and MDR 2017; Availability of valid Medical Device license
- These items form the basis for supplier qualification and regulatory alignment for guaranteed supply to BHEL.
Terms, Conditions & Eligibility
- GST invoice upload on GeM with GST portal payment screenshot
- Advance sample approval required before bulk manufacturing; supply 02 samples within 7 days of award; modifications to be communicated within 7 days
- If buyer delays approval, delivery period is adjusted with no LD; major deviations may trigger replacement samples or contract termination
- Payments within 90 days of CRAC issuance on online bill submission; submit 3 tax invoices with original seal and signature along with GEM contract
- Compliance with these ATC clauses is mandatory for bid submission.
Key Specifications
-
Sterility: must be ensured for all sutures
-
Type of Suture: specified in tender (not enumerated here)
-
Suture Material: medical-grade material
-
Suture Construction: defined in product spec
-
Suture Size and Length: exact size and ± tolerances
-
Needle included: yes; Needle Type and Curvature
-
Needle Length: ±0.5mm per arm
-
Packing: number of strands per pack
-
Shelf Life: residual shelf life
-
Certifications: Drugs and Cosmetic Act 1940; MDR 2017; valid Medical Device license
Terms & Conditions
-
GST invoicing via GeM with GST portal payment proof
-
Advance sample approval process with 2 samples in 7 days
-
90-day payment post CRAC with online bill submission
-
Submission of 3 tax invoices with original seal and signature
-
Compliance with MDR 2017 and Medical Device license requirements
Important Clauses
Payment Terms
Payments will be made within 90 days of CRAC issuance upon online bill submission; GST invoice and payment screenshot required in GeM portal.
Delivery Schedule
Advance sample approval required; 2 samples within 7 days of award; delivery timeline may be refixed if buyer delays approval; bulk supply contingent on sample conformity.
Penalties/Liquidated Damages
LD not specified; delivery period reframing occurs on buyer delay; major deviations may lead to contract termination after notification.
Bidder Eligibility
-
GST registration and ability to upload GST invoice in GeM
-
Compliance with Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license
-
Experience in supplying surgical sutures or medical devices; demonstrated capability for sterile products
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
No
Item Category
Surgical Sutures (Q2)
Authority Records
MINISTRY OF HEAVY INDUSTRIESHEAVY INDUSTRY DEPARTMENT
BID & GeM Expert Consultancy
End-to-end support — bid preparation, GeM registration, document filing & compliance by industry experts.
Bid Preparation
GeM Registration
Document Filing
Free consultation · 24h response
Documents 3
GeM-Bidding-9430434.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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Tender Results
Loading results...
Technical Specifications
1 Item
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Sterility | Sterile |
| PRODUCT INFORMATION | Type of Suture | Non Absorbable |
| PRODUCT INFORMATION | Suture Material (Medical Grade) | Black Braided Silk |
| PRODUCT INFORMATION | Suture Construction | Multi-filament |
| PRODUCT INFORMATION | Suture Size | 3-0 |
| PRODUCT INFORMATION | Suture Length (±2cm) | 75 cm |
| PRODUCT INFORMATION | Needle included | Single Arm Needle |
| PRODUCT INFORMATION | Type of Needle | Round Bodied |
| PRODUCT INFORMATION | Needle Length of each arm (±0.5mm) | 25 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 (medical device/surgical sutures preferred)
4
Financial statements (as required by tender terms)
5
EMD documentation (not explicitly provided, assume as per GeM terms)
6
Technical bid documents demonstrating sterility, suture material, size, length, and needle specifications
7
OEM authorizations or manufacturer-proxy documentation (if applicable)
8
Medical Device license/details for the product
9
GST invoice sample format and portal payment proof screenshots
Frequently Asked Questions
How to bid on the surgical sutures tender in India with MDR 2017 compliance?
Bidders must meet regulatory criteria: Drugs and Cosmetic Act 1940 compliance, MDR 2017 adherence, and a valid Medical Device license. Provide GST registration, OEM authorizations if required, and samples for pre-approval within 7 days of award. Ensure online GeM invoice submission and CRAC-based payment readiness.
What documents are required for the sutures procurement bid in India?
Submit GST certificate, PAN, financial statements, experience certificates for medical devices, 3 tax invoices with seal, and Medical Device license details. Include technical bid demonstrating sterility, suture material, size, length, needle type, and packaging specifics for each pack.
What are the technical specifications for the sutures under MDR 2017?
Specifications include sterility, medical-grade suture material, defined suture construction and size, length within ±2cm, needle included with specific length per arm (±0.5mm) and curvature. Packing must state number of strands per pack and residual shelf life; compliance with MDR 2017 is mandatory.
When is the payment due after CRAC for the sutures purchase?
Payment is due within 90 days of issue of the consignee receipt-cum-acceptance certificate (CRAC) upon online bill submission. Ensure GST invoice and GeM confirmation are complete to avoid delays in processing.
What is required for advance sample approval before bulk supply?
Submit 02 samples within 7 days of award; buyer will approve or request modifications within 7 days. If delayed, the delivery period is refixed without LD; major deviations may trigger fresh samples or contract termination.
What certifications prove regulatory compliance for sutures tender in India?
Bidders must show Compliance to Drugs and Cosmetic Act 1940 and MDR 2017, plus a valid Medical Device license issued by the competent authority. These ensure product safety and regulatory alignment for government procurement.
What is required on GeM for invoicing and GST verification?
Upload a scanned GST invoice and the GST portal payment confirmation screenshot within GeM. This supports the 90-day payment cycle and ensures eligibility for CRAC-based payment processing.
What packing and shelf-life details must be specified for sutures?
Provide Number of Strands per Pack and Residual shelf life details. Also confirm the Needle length (±0.5mm), Needle curvature, and ensure sterility and medical-grade material per MDR requirements.
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Documents 3
GeM-Bidding-9430434.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS