NLC India Limited Biochemistry Reagent Kit Tender Cuddalore Tamil Nadu 2017 MDR Compliance
Bid Publish Date
29-Aug-2026, 2:03 pm
Bid End Date
14-Sep-2026, 4:00 pm
Location
Progress
Key Highlights
- • Regulatory compliance: MDR 2017 amendments and Drugs and Cosmetic Act 1940 required
- • Mandatory Medical Device license validity from competent authority
- • Calibrator and control materials included with each reagent pack
- • Traceability certificate required with calibrators
- • IP address tracking to prevent bid manipulation
- • Scope: Only supply of goods; no installation or services
- • Option clause not specified beyond standard quantity variation
- • Bidders must submit ATC document with filled clauses and signing
Tender Overview
NLC India Limited, Materials Management, invites bids for a Biochemistry Reagent Kit for Human Samples in CUDDALORE, TAMIL NADU 605106. Estimated value and EMD are not disclosed. The scope emphasizes provision of reagents with calibrators and controls, packaging details, and compliance with drug and medical device regulations. The tender highlights mandatory MDR compliance, traceability certificates, and a Medical Device license. A critical differentiator is the inclusion of calibrators and controls with each pack, plus packaging volume data. This procurement targets suppliers able to meet regulatory standards and supply chain traceability requirements for medical reagents. Unique aspects include repeated data points on sample type, test type, and form of reagent, underscoring stringent regulatory alignment and batch-level traceability.
Technical Specifications & Requirements
- Category: PRODUCT INFORMATION; Packaging: Total Volume of Reagent per Pack; Form of reagent at supply; Supported type of sample; Type of Test; Calibrator provided with each pack; Control provided with each pack; Certifications: MDR 2017 compliance; valid Medical Device license from competent authority; traceability certificate with calibrators.
- Compliance must align with: Drugs and Cosmetic Act 1940 and Medical Device Rules 2017 as amended.
- Emphasis on product traceability and calibration certificates; repetition in data points indicates robust quality assurance requirements.
- Documentation must demonstrate regulatory licenses and product conformity.
Terms, Conditions & Eligibility
- EMD: not disclosed; bidders must verify on GeM submission portal.
- Delivery & Scope: Only supply of Goods; no services in scope.
- ATC & Documents: Upload all required certificates; non-submission leads to rejection.
- Additional terms include IP-address capture to prevent bid collusion; refer to GeM terms.
- Ensure compliance with MDR, ISI/ISO where stated, and maintain traceability for calibrators.
- Bidders must submit duly completed Additional Terms and Conditions and a declaration of banning/debarment.
Key Specifications
-
Biochemistry reagent kit for human samples with calibrator and control per pack
-
Total volume per pack: not explicitly specified
-
Form of reagent: not explicitly specified
-
Supported sample type: specified but not enumerated in data
-
Test type: specified but not enumerated
-
Standards: MDR 2017 amendments; Drugs and Cosmetic Act 1940
-
Certification: valid Medical Device license; traceability certificate
-
Delivery location: Cuddalore, Tamil Nadu 605106
Terms & Conditions
-
EMD amount not disclosed; verify on GeM portal
-
Delivery scope limited to supply of goods only
-
ATC documents must be completed and signed; non-submission leads to rejection
Important Clauses
Payment Terms
Not explicitly stated; follow GeM standard terms and contract-specific ATC
Delivery Schedule
Delivery period may be influenced by option clause; quantity variations up to 25% allowed
Penalties/Liquidated Damages
Not specified; refer to GeM buyer terms and contract provisions
Bidder Eligibility
-
Experience in supplying biochemistry reagent kits with calibrators and controls
-
Demonstrated MDR 2017 compliance and valid Medical Device license
-
Traceability documentation for calibrators and per-pack control materials
Tender Data
Bid Details
Quantity
194
Category
Biochemistry Reagent Kit for Human Samples
Bid Type
Two Packet Bid
Bid Validity
180 (Days)
Bid Type
Service
Evaluation
Item wise evaluation
Inspection Required
No
RA Qualification Rule
50% Lowest Priced Technically Qualified Bidders
Tech Clarification Time
4 Days
Preference & Exemptions
EMD Required
No
MII Purchase Preference
Yes
MII Preference Band
L1+20%
MSE Purchase Preference
Yes
MSE Preference Band
L1+15%
MSE Exemption/Relaxation
No
Startup Exemption/Relaxation
No
Bid Splitting Applied
No
Requirements
Arbitration Clause
No
Mediation Clause
No
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Biochemistry Reagent Kit for Human Samples (Q2) ( PAC Only )
Advisory Bank
State Bank of India
ePBG Percentage
5%
ePBG Duration (Months)
4
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
30
Delivery Locations
1
Delivery Cities
Cuddalore
Delivery Pincodes
607803
Delivery Locations
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| Vivekanandan Kaliyamurthy | 607803,NLC GENERAL HOSPITAL MEDICAL STORES, NLC INDIA LIMITED, BLOCK-6, NEYVELI TOWNSHIP | Cuddalore | Tamil Nadu | 607803 | 30 | 30 | - |
Authority Records
BID & GeM Expert Consultancy
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Documents 12
GeM-Bidding-9811489.pdf
Main Document
Other Documents
OTHER
CATALOG-Specification-1
CATALOG Specification
CATALOG-Specification-2
CATALOG Specification
CATALOG-Specification-3
CATALOG Specification
CATALOG-Specification-4
CATALOG Specification
CATALOG-Specification-5
CATALOG Specification
CATALOG-Specification-6
CATALOG Specification
CATALOG-Specification-7
CATALOG Specification
Other Documents
OTHER
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
Categories
2
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Required Documents
GST registration certificate
Permanent Account Number (PAN) card
Experience certificates for similar biochemistry reagent kit supply
Financial statements showing solvency
EMD/Security deposit documents (as applicable by GeM)
Technical bid documents detailing MDR compliance and licenses
OEM authorization or manufacturer credentials
Medical Device license document
Traceability certificates for calibrators
Declaration of banning/debarment
Technical Specifications
7 Items
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Supported type of sample | Serum |
| PRODUCT INFORMATION | Type of Test | Creatine Kinase (CK-NAC) |
| PRODUCT INFORMATION | Form of reagent at the time of supply | Liquid |
| PACKAGING | Total Volume of Reagent per Pack | 110 ml |
| 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 |
Frequently Asked Questions
Key insights about TAMIL NADU tender market
How to bid for the biochemistry reagent kit tender in Tamil Nadu
Bidders must complete GeM portal registration, upload MDR compliance proof, provide Medical Device license, and attach calibrator/control traceability certificates. Include GST, PAN, and experience certificates showing similar kit supply. Ensure packaging volume data per pack and demonstrate regulatory conformity for Drugs and Cosmetic Act 1940.
What documents are required for the reagent kit tender in Cuddalore
Submit GST certificate, PAN card, experience certificates, financial statements, EMD documentation, technical bid detailing MDR compliance, OEM authorization, Medical Device license, traceability certificates for calibrators, and a banning/debarment declaration as requested by ATC.
What standards and licenses must the reagent kit comply with
Product must comply with Drugs and Cosmetic Act 1940 and MDR 2017 as amended; maintain a valid Medical Device license; provide traceability certificates with calibrators; IS/ISO responsibilities are referenced but not explicitly listed.
When is the delivery period for the reagent kit contract
Delivery terms allow for quantity variation up to 25% and may reference extended delivery periods from original order date; exact delivery timeline will be defined in the purchase order following GeM bid evaluation.
What is included in the scope of supply for this tender
Scope is limited to supply of goods: biochemistry reagents with calibrators and controls per pack; no installation or services; ensure total pack volume and per-pack contents are clearly specified in the bid.
How to verify the traceability certificates for calibrators
Bidders must attach traceability certificates with calibrators per pack; certificates should link calibrator lot numbers to batch evidence and comply with regulatory traceability requirements mandated by MDR and drug laws.