Dehradun Haematology Analyzer Reagents Tender Uttarakhand 2026 MDR Act Compliance
Bid Publish Date
29-Aug-2026, 1:08 pm
Bid End Date
08-Sep-2026, 7:00 pm
Location
Progress
Tender Overview
The tender in Dehradun, Uttarakhand invites suppliers for Haematology Analyzer Reagents, requiring compliant reagent products with defined packaging volumes and reactivity details. Key deliverable focuses on reagents meeting Drugs and Cosmetic Act 1940 and MDR 2017, plus valid Medical Device licenses. While the purchaser reserves a flexible quantity option up to 25% more or less than bid quantity, the delivery timeframe pivots on original delivery terms. This opportunity targets suppliers with cleared regulatory authorizations and a track record in medical device compliance, ensuring product traceability and regulatory conformity.
Technical Specifications & Requirements
- Product information: Reactivity and Type of Reagent as essential attributes; Total Volume of Reagent per Pack is specified
- Certifications: Compliance to Drugs and Cosmetic Act 1940; MDR 2017 (as amended) and valid Medical Device license issued by competent authority
- Packaging details: Total volume per pack clearly defined; reagents must be suitable for haematology analyzer usage
- Compliance evidence: Documentation proving active medical device license and regulatory clearance
- Quality expectations: Reagents must conform to national medical device regulatory standards; expected for hospital/clinical use
- Commercial nuance: No BOQ items present; quantity adjustments permitted under 25% option clause
- Notes: Ensure alignment with purchaser’s option to modify quantity during contract period
Terms, Conditions & Eligibility
- Quantity flex: Purchaser may increase/decrease order by up to 25% of bid quantity; extension of delivery period follows a calculated formula linked to original delivery
- Delivery timing: Delivery schedule linked to last date of original/extended order; minimum extension logic applies
- Mandatory compliance: Bidders must demonstrate adherence to MDR 2017 and Drugs and Cosmetic Act 1940
- Documentation: Prepare and submit valid medical device license, regulatory clearances, and product-specific certifications
- Payment terms: Not specified in data; ensure readiness for regulatory-compliant invoicing and delivery verification
- Risk and penalties: Standard procurement penalties apply if regulatory or delivery terms are breached
- Language: All terms are aligned with government procurement norms and post-award obligations
Key Specifications
-
Reagent product information: Reactivity and Type of Reagent
-
Packaging: Total Volume of Reagent per Pack
-
Certifications: Compliance to Drugs and Cosmetic Act 1940 and MDR 2017
-
Licensing: Availability of valid Medical Device license for the product
-
Regulatory: MDR 2017 amended till date compliance
-
Delivery: Basic delivery terms subject to option clause
Terms & Conditions
-
25% quantity variation allowed by purchaser at contract placement or during currency
-
Delivery period adjustments based on original delivery timeline with minimum 30 days
-
Regulatory compliance with Drugs and Cosmetic Act 1940 and MDR 2017; valid medical device license required
Important Clauses
Payment Terms
Payment terms are not explicitly specified; bidders should anticipate standard government payment on delivery and confirm terms during bid submission
Delivery Schedule
Delivery starts from the last date of the original delivery order; extended delivery time is calculated as (increased quantity ÷ original quantity) × original delivery period, with a minimum of 30 days
Penalties/Liquidated Damages
Penalties for non-compliance with regulatory requirements or delivery timelines are implied under standard procurement terms; specific LD rates not provided
Bidder Eligibility
-
Eligibility to supply haematology reagents meeting MDR 2017 and Drugs and Cosmetic Act 1940
-
Demonstrated regulatory clearance with valid Medical Device license for the product
-
Financial stability and capability to meet potential 25% quantity variation
Tender Data
Bid Details
Quantity
16
Category
Haematology Analyzer Reagents (V2)
Bid Type
Two Packet Bid
Bid Validity
180 (Days)
Bid Type
Service
Evaluation
Total value wise evaluation
Inspection Required
No
Tech Clarification Time
2 Days
Preference & Exemptions
EMD Required
No
MII Purchase Preference
No
MSE Purchase Preference
Yes
MSE Preference Band
L1+15%
MSE Exemption/Relaxation
Yes
Startup Exemption/Relaxation
Yes
Bid Splitting Applied
No
Requirements
Past Performance
30 %
Experience Required
1 Year (s)
Arbitration Clause
No
Mediation Clause
No
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
No
Item Category
Haematology Analyzer Reagents (V2) (Q2)
Delivery Details
Max Delivery Days
15
Delivery Locations
1
Delivery Cities
Dehradun
Delivery Pincodes
248159
Delivery Locations
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| Sameer Kumar | 248159,Ordnance Company, Plot No 129, Near Kalsi Gate, Kalsi, District-Dehradun, Uttarakhand | Dehradun | Uttarakhand | 248159 | 6 | 15 | - |
BID & GeM Expert Consultancy
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Documents 5
GeM-Bidding-9820584.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
CATALOG-Specification-2
CATALOG Specification
CATALOG-Specification-3
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
Corrigendum Updates
1 Update Update
Extended Deadline
08-Sep-2026, 1:30 pm
Opening Date
09-Sep-2026, 1:30 pm
Categories
5
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Required Documents
GST registration certificate
Permanent Account Number (PAN) card
Experience certificates for relevant reagent supply
Financial statements (last 2-3 years)
EMD/Security deposit proof (as applicable)
Technical bid documents showing reagent specifications
OEM authorizations (if applicable)
Regulatory licenses for medical device/reagents (valid license from competent authority)
Compliance certificates for Drugs and Cosmetic Act 1940 and MDR 2017
Product technical specifications and QA/QC reports
Technical Specifications
3 Items
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 |
Frequently Asked Questions
Key insights about UTTARAKHAND tender market
How to bid for haematology reagents tender in Dehradun 2026?
Bidders must submit GST, PAN, experience certificates, financial statements, EMD proof, technical bid with reagent specifications, OEM authorizations if required, and regulatory licenses proving MDR 2017 compliance and Drugs and Cosmetic Act 1940 adherence. Ensure availability of valid Medical Device license for the product and readiness for 25% quantity variation.
What documents are required for MDR 2017 compliant reagents in Dehradun?
Submit regulatory licenses validating medical device status, Drugs and Cosmetic Act compliance certificates, and detailed product specifications including reactivity type and packaging volume per pack. Include financials, GST, PAN, experience letters, and OEM authorizations where applicable.
What are the delivery terms for 25% quantity variation in this tender?
The purchaser may adjust quantity by up to 25% at contract placement or during currency. Delivery period recalculation uses (increased quantity ÷ original quantity) × original delivery period, with a minimum 30 days; extensions follow the same rule and respect original timeline.
Which standards must reagents comply with for this Dehradun bid?
Reagents must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended. A valid Medical Device license from the competent authority is mandatory, ensuring regulatory clearance for hospital or clinical use.
What is the scope of packaging volume requirements for reagents?
Bidders must provide Total Volume of Reagent per Pack as part of product information. Ensure packaging volume aligns with analyzer compatibility and includes clear labeling, lot numbers, and expiry details per pack.
What is required to demonstrate eligibility for haematology reagents supply?
Eligibility requires MDR 2017 and Drugs Act compliance, valid medical device licensing, demonstrable experience in supplying similar reagents, and financial stability. Bidder must also be able to handle quantity variation without impacting delivery deadlines.
What are the key regulatory licenses required for this tender?
Key licenses include a valid Medical Device license for the reagents and compliance certificates under Drugs and Cosmetic Act 1940 and MDR 2017. Providing authentic license numbers and issuing authority details is essential during bid submission.
How will delivery deadlines be calculated if quantities change?
Delivery timelines will adjust using the formula (increased quantity ÷ original quantity) × original delivery period, with a guaranteed minimum of 30 days. The purchaser may extend the calculated duration up to the original delivery period.