Gujarat Health & Family Welfare Department Haematology Analyzer Reagents (V2) Tender Banaskantha Gujarat 2026
N/a
BANASKANTHA, GUJARAT
Posted:
23 January 2026
Closed:
13 February 2026
GEM
GEM
Health & Family Welfare Department Gujarat Haematology Analyzer Reagents Tender Banaskantha 2026 - Drugs & Cosmetic Act MDR 2017 Compliance
Bid Publish Date
25-May-2026, 6:40 pm
Bid End Date
04-Jun-2026, 7:00 pm
Location
Progress
Issue25-May-2026, 6:40 pm
AwardPending
Quantity
12
Bid Type
Two Packet Bid
Categories
5
Tender Overview
The tender is issued by the Health & Family Welfare Department Gujarat for Haematology Analyzer Reagents (V2) Q2 intended for procurement in BANASKANTHA, GUJARAT (385001). Key procurement details include product category focusing on reagents with specified reactivity and reagent type, plus packaging specifics like total volume per pack. Required certifications include compliance with the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended, along with a valid Medical Device license issued by the competent authority. The absence of a BOQ indicates a likely product-list based requirement rather than quantity-led sourcing. The tender emphasizes regulatory alignment and licensure to ensure patient safety within health infrastructure. The opportunity hinges on meeting statutory standards and license prerequisites, with emphasis on reagent reliability and traceability in a hospital setting.
Technical Specifications & Requirements
- Product Information: Reagent reactivity; Type of Reagent; Total Volume per Pack; packaging details.
- Certifications: Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 compliance; valid Medical Device license from competent authority.
- Only essential product attributes are specified; no BOQ items are available.
- The absence of price-led items suggests a focus on conformance with regulatory and biosafety standards, ensuring reagents suit hematology analyzers used in clinical diagnostics.
- End-user clinical utility is implied by standard-compliant hematology reagent packaging and supply continuity.
Terms, Conditions & Eligibility
- Buyer Added Clause: Quantity may vary up to 25% during contract and delivery windows; additional time calculated as (Increase/Original) × Original delivery period, minimum 30 days.
- Compliance with all statutory requirements and the ability to supply reagents under healthcare procurement norms is essential.
- Bidders must adhere to delivery terms aligned with the extended delivery period and price stability at contracted rates.
Key Specifications
-
- Product Information: Reactivity details; Type of Reagent; Total Volume per Pack specified
-
- Certifications: Compliance to Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license
-
- Packaging details for reagent packs; regulatory traceability information
-
- No BOQ items available; focus on regulatory compliance and product attributes
-
- Emphasis on supplier capability to meet health department procurement standards
Terms & Conditions
-
Key Term 1: Quantity variation up to 25% during contract and extended delivery period
-
Key Term 2: Delivery time to be adjusted based on option clause with minimum 30 days
-
Key Term 3: Regulatory compliance with Drugs and Cosmetic Act and MDR 2017; valid Medical Device license
Important Clauses
Payment Terms
Not specified in data; standard government procurement terms to be confirmed during bid
Delivery Schedule
Delivery period determined by order date; extended delivery time applies per option clause with minimum 30 days
Penalties/Liquidated Damages
Not specified in data; penalties to be defined within contract post-bid.
Bidder Eligibility
-
Proven track record in supplying hematology reagents or medical devices to government health facilities
-
Valid GST, PAN, and financial statements available for bid submission
-
Regulatory compliance with Drugs and Cosmetic Act and MDR 2017; possession of Medical Device license
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
No
Item Category
Haematology Analyzer Reagents (V2) (Q2)
Authority Records
HEALTH AND FAMILY WELFARE DEPARTMENT
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Documents 3
GeM-Bidding-9379065.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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Closed:
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GEM
Tender Results
Loading results...
Technical Specifications
1 Item
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Reactivity | Human |
| PRODUCT INFORMATION | Type of Reagent | Diluent |
| PACKAGING | Total Volume of Reagent per Pack | 20000 ml |
| CERTIFICATIONS & REPORTS | Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS & REPORTS | Availability of valid Medical Device license for the product issued from the competent authority | Yes |
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Historical Data
Required Documents
1
GST registration certificate
2
PAN card
3
Experience certificates in supplying hematology reagents or medical devices
4
Financial statements for the last two fiscals
5
EMD/Security deposit details (if applicable in tender terms)
6
Technical bid documents demonstrating regulatory compliance
7
OEM authorizations or distributorship agreements (if applicable)
8
Medical Device license or equivalent certification
Frequently Asked Questions
Key insights about GUJARAT tender market
How to bid for the Haematology reagents tender in Banaskantha Gujarat?
To bid, ensure compliance with Drugs and Cosmetic Act 1940 and MDR 2017, secure a valid Medical Device license, provide GST and PAN, furnish financials, and attach OEM/authorizations. The tender may allow 25% quantity variation; confirm delivery timelines and submit technical bid detailing reagent type and packaging volume.
What documents are required for this Gujarat reagents procurement bid?
Submit GST certificate, PAN card, experience certificates in medical devices, two fiscal-year financial statements, EMD details if applicable, technical compliance documents, OEM authorizations, and a valid Medical Device license. Ensure packaging and volume details align with reagent specifications.
What certifications are mandatory for Haematology Reagents in Gujarat?
Bidders must show compliance with Drugs and Cosmetic Act 1940 and MDR 2017, and hold a valid Medical Device license. Provide certification copies and regulatory proof for all reagents offered and ensure traceability to the competent authority.
What is the potential quantity variation allowed in this tender?
The purchaser may increase or decrease the quantity up to 25% of the bid/contract quantity at the time of order placement or during the currency of the contract, using contracted rates and a minimum delivery extension of 30 days.
What are the essential delivery and payment terms for this procurement?
Delivery terms follow the option clause with delivery extensions based on quantity changes; payment terms will be defined in the contract. Bidders should prepare for schedule alignment with order dates and possible extended delivery periods per clause.
How to demonstrate regulatory compliance for these reagents in Gujarat?
Provide proof of Drugs and Cosmetic Act compliance, MDR 2017 adherence, and a valid Medical Device license from the competent authority. Include licenses with itemized reagent specifics and packaging details to verify compliance.
What is required to prove supplier capability for government health supply?
Show prior government or large-health-facility deployments, demonstrate stable turnover via financial statements, provide GMP/quality control documentation if applicable, and present OEM authorizations or distributorships for the reagent products.
Where do I obtain the Medical Device license for reagents in Gujarat?
License issuance is through the competent authority in India; bidders must attach the license details, license number, issuing authority, and validity dates in the bid. Ensure license covers the specific reagent types and packaging volumes offered.
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Documents 3
GeM-Bidding-9379065.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS