Total Knee Replacement Implant (V2)
New Civil Hospital
SURAT, GUJARAT
Posted:
7 August 2025
Closed:
25 August 2025
GEM
GEM
Gujarat Health & Family Welfare Department Knee Replacement Implant Tender Gujarat Kachchh 2026 MDR CDSCO
Progress
Issue08-Jul-2026, 7:04 pm
AwardPending
Quantity
6
Bid Type
Two Packet Bid
Tender Overview
Gujarat Health & Family Welfare Department invites bids for a Total Knee Replacement Implant (V2) in KACHCHH, GUJARAT with an estimated value of ₹3,00,000.00. The scope includes femoral and tibial components with medical-grade materials, tibial baseplate, patellar and patellar tracking elements, surface coating, bone cement provision, locking mechanisms, and compatibility across tibial/femoral components. Compliance with MDR 2017, CDSCO license, and batch test reports are required. Shelf-life specifications and packaging type are defined, with emphasis on capstone certifications and unit-level documentation delivered with supplies. The absence of BOQ items indicates a standardized implant package subject to buyer requirements.
- Key differentiator: strict regulatory compliance (MDR 2017, CDSCO) and batch testing for every supply
- Unique aspect: mandatory certification packages delivered at bid submission or with supplies
- Location-based tender: tender in Gujarat for knee implant procurement
Technical Specifications & Requirements
- Product category: Total Knee Replacement Implant (V2); includes Femoral Component Material (Medical Grade), Tibial Component Material (Medical Grade), Tibial Baseplate, Tibial Insert Material, Patellar component material, and Surface Coating
- Design/assembly: Articulation Type, Locking Mechanism for Insert, and Trochlear Groove details
- Compliance: MDR 2017, CDSCO License validity, Manufacturing Unit Certification, Batch Test Reports per MDR
- Shelf life: specify Total Shelf Life From Manufacture (Months) and minimum shelf life at delivery
- Additional: Packing Type, delivery/installation expectations, and material compatibility between tibial/femoral/patellar components
Terms, Conditions & Eligibility
- EMD: not specified in public data; bidders must verify with procurement authority
- Delivery terms: option clause allows quantity +/-25% with adjusted delivery periods; baseline delivery timing not provided
- Documentation: bidder must submit all required certifications, licenses, and test reports at bid or with supply
- Warranty/after-sales: not explicitly stated; ensure alignment with MDR and CDSCO expectations
- Compliance: provide batch-wise test reports and manufacturing certifications to buyer upon bid submission or delivery
- Penalties: standard procurement extension rules apply for option quantity and delivery adjustments
Key Specifications
-
Total Knee Replacement Implant (V2) package includes: Femoral Component Material (Medical Grade), Tibial Component Material (Medical Grade), Tibial Baseplate, Tibial Insert Material, Patellar component material, Surface Coating, Locking Mechanism for Insert, Trochlear Groove
-
Packing Type as specified by buyer
-
Shelf Life: Total shelf life from manufacture in months; minimum remaining shelf life at delivery
-
Standards: MDR 2017 compliance; CDSCO license; Manufacturing Unit Certification; batch test reports per MDR
-
Compatibility: Tibial insert components compatible with Tibial and Femoral components and Patellar component
Terms & Conditions
-
Option to increase/decrease quantity by 25% at contract delivery with proportional timelines
-
Delivery period adjustments are calculated as (Increased quantity / Original quantity) × Original delivery period, with a minimum of 30 days
-
Buyer may extend delivery duration up to the original delivery period during option exercise
Important Clauses
Payment Terms
Not specified in available data; bidders should confirm with purchaser
Delivery Schedule
Delivery quantity adjustments allowed up to 25%; delivery timing linked to original delivery period with minimum 30 days; extended periods may apply
Penalties/Liquidated Damages
Standard procurement penalties apply for late delivery; exact LD rate not disclosed in current data
Bidder Eligibility
-
Demonstrated experience supplying medical implants or orthopedic devices
-
Compliance with MDR 2017, CDSCO licensing, and batch testing requirements
-
Ability to provide batch-wise test reports and complete certification package at bid/delivery
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Total Knee Replacement Implant (V2) (Q2)
Payment Timelines
Payments shall be made to the Seller within 45 days of issue of consignee receipt-cum-acceptance certificate (CRAC) and on-line submission of bills (This is in supersession of 10 days time as provided in clause 12 of GeM GTC)
Delivery Details
Max Delivery Days
15
Delivery Locations
1
Delivery Cities
Kachchh
Delivery Pincodes
370205
Delivery Locations
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| Kuldip Vijaybhai Chavada | 370205,Government Hospital Gandhidham Rambag Road, Adipur-370205 | Kachchh | Gujarat | 370205 | 6 | 15 | - |
Authority Records
HEALTH AND FAMILY WELFARE 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-9578999.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
Past Similar Tenders
(Historical Results)
5 found
Civil Hospital Amdavad Total Knee Replacement Implant Tender in Ahmedabad Gujarat 2025 - V2 TKR Implant Standards
Civil Hospital Amdavad
AHMEDABAD, GUJARAT
Posted:
30 October 2025
Closed:
15 November 2025
GEM
Total Knee Replacement Implant (V2)
Ssg Hospital Vadodara
VADODARA, GUJARAT
Posted:
16 September 2025
Closed:
26 September 2025
GEM
Total Knee Replacement Implant (V2)
Employees State Insurance Corporation
WEST DELHI, DELHI
Posted:
3 November 2025
Closed:
16 December 2025
GEM
Total Knee Replacement Implant (V2)
Employees State Insurance Corporation (esic)
FARIDABAD, HARYANA
Posted:
16 February 2026
Closed:
19 March 2026
GEM
Tender Results
Loading results...
Technical Specifications
1 Item
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| GENERAL | Product Description | Total Knee Replacement Implant |
| GENERAL | Sterility | Sterile |
| PRODUCT SPECIFICATION | Components | Femoral Component, Tibial Component, Tibial Articulating Surface, Patella |
| PRODUCT SPECIFICATION | Implant Type | Posterior Stabilized (PS) |
| PRODUCT SPECIFICATION | Femoral Component Material (Medical Grade) | Cobalt-Chromium Alloy |
| PRODUCT SPECIFICATION | Tibial Component Material (Medical Grade) | Cobalt-Chromium Alloy |
| PRODUCT SPECIFICATION | Tibial Baseplate | Metal-Backed |
| PRODUCT SPECIFICATION | Tibial Insert Material | Ultra High Molecular Weight Polyethylene (UHMWPE) |
| PRODUCT SPECIFICATION | Articulation Type | Fixed-Bearing |
| PRODUCT SPECIFICATION | Locking Mechanism for Insert | Yes |
| PRODUCT SPECIFICATION | Patellar component material | Ultra High Molecular Weight Polyethylene (UHMWPE) |
| PRODUCT SPECIFICATION | Surface Coating | Polished |
| PRODUCT SPECIFICATION | Fixation Method | Cemented |
| PRODUCT SPECIFICATION | Bone cement provided | Yes |
| PRODUCT SPECIFICATION | Trochlear Groove | Standard |
| PRODUCT SPECIFICATION | Flexion Range | Standard, High Flex |
| PRODUCT SPECIFICATION | Tibial insert components shall be compatible with Tibial and Femoral component (Patellar Component) | Yes |
| PACKING | Packing Type | Moisture Proof Sterile Packing |
| CERTIFICATIONS | Compliance to Medical Device Rule (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Availability of valid medical device license (CDSCO License) for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes |
| CERTIFICATIONS | Manufacturing Unit Certification | ISO:13485 (Latest) |
| CERTIFICATIONS | Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement | Yes |
| SHELF LIFE | Total Shelf Life From the Date of Manufacture (Months) | 60 Or higher |
| SHELF LIFE | Minimum shelf life of the product at the time of delivery to the consignee | 60% of Total Shelf Life, 75% of Total Shelf Life Or higher |
🤖 AI-Powered Bidder Prediction
Discover companies most likely to bid on this tender
Live AI
Historical Data
Required Documents
1
GST registration certificate
2
PAN card
3
Experience certificates for medical device supply
4
Financial statements or turnover evidence
5
EMD/Security deposit documentation (if applicable by buyer guidance)
6
Technical bid documents demonstrating MDR 2017 compliance
7
CDSCO medical device license validity
8
Manufacturing Unit Certification
9
Submission of test reports for each batch as per MDR 2017
10
OEM authorizations or approvals (if required by buyer)
Frequently Asked Questions
Key insights about GUJARAT tender market
How to bid for knee implant tender in Kachchh Gujarat 2026
Submit MDR 2017 compliance evidence, CDSCO license, and batch test reports. Provide OEM authorization if required, GST, PAN, and financials. Ensure packaging and shelf life details match specifications, and deliver with the required certification package at bid submission or with supplies.
What documents are required for knee implant procurement in Gujarat
Required documents include GST certificate, PAN, company financial statements, MDR 2017 compliance certificates, CDSCO license, Manufacturing Unit Certification, batch test reports, and OEM authorizations. Prepare experience certificates showing orthopedic device supply, and ensure bid includes all tests for each batch.
What standards and certifications are mandatory for knee implants
Mandatory MDR 2017 compliance, valid CDSCO medical device license, and Manufacturing Unit Certification. Each batch must include test reports per MDR 2017, with certification packages provided to the buyer during bid submission or delivery.
What is the delivery term flexibility for knee implants in Gujarat
The buyer may adjust quantity by ±25% at contract delivery. The extended delivery period uses the formula (Increased quantity / Original quantity) × Original delivery period, with a minimum of 30 days and possible extension up to the original delivery period.
What is the estimated value of the knee implant procurement in Gujarat
The estimated value is ₹3,00,000.00 for the Total Knee Replacement Implant (V2) package, reflecting a compact procurement scope requiring MDR and CDSCO-compliant implants with batch testing.
Which components are included in the knee implant package
Package includes Femoral Component Material (Medical Grade), Tibial Component Material (Medical Grade), Tibial Baseplate, Tibial Insert Material, Patellar component material, Surface Coating, Locking Mechanism for Insert, and Trochlear Groove, plus packing details.
What is required for batch test reporting in this tender
Bidders must provide test reports for each supplied batch as per Medical Device Rule MDR 2017, along with CDSCO license information and batch-level certifications for buyer verification at submission or delivery.
What is the shelf-life requirement for knee implants
Specify Total Shelf Life From Manufacture in months and ensure minimum shelf life at the time of delivery to the consignee, aligning with MDR 2017 batch testing and CDSCO licensing.
Similar Tenders
5 found
Urgent
Total Knee Replacement Implant (V2),Total Knee Replacement Implant (V2)
Employees State Insurance Corporation (esic)
📍 KOLLAM, KERALA
EMD: ₹2.3 L
Est: ₹74.5 L
⏰ Deadline: 2 days left
🛒 Type: Goods
View
GEM
Total Knee Replacement Implant (V2)
N/a
📍 AMRELI, GUJARAT
EMD: ₹30,000
Est: ₹10.0 L
⏰ Deadline: 2 weeks left
🛒 Type: Goods
View
GEM
Total Knee Replacement Implant (V2)
Employees State Insurance Corporation
📍 VALSAD, GUJARAT
Est: ₹3.0 L
⏰ Deadline: 2 weeks left
🛒 Type: Goods
View
GEM
Urgent
Knee Braces and Splints (V2),Knee Braces and Splints (V2)
Indian Army
📍 JALANDHAR, PUNJAB
⏰ Deadline: 2 days left
🛒 Type: Goods
View
GEM
Laparoscopic Surgery System (V2)
Health Services
📍 AIZAWL, MIZORAM
⏰ Deadline: 2 weeks left
🛒 Type: Goods
View
GEM
Explore More Opportunities
Quick Access
Unlock Tender Documents
Sign up now to access all documents
Performance Analytics
7-metric analysis with year-wise breakdown
Competitor Intelligence
Multi-dimensional analysis across 6 parameters
Market Penetration
By department, ministry, geography & category
Historical Analysis
Complete tender history with results
Documents 3
GeM-Bidding-9578999.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS