Department Of Health And Family Welfare Nucleic Acid Extraction Kit Tender North Delhi 2017 MDR Compliance
Bid Publish Date
02-Sep-2026, 2:32 pm
Bid End Date
17-Sep-2026, 11:00 am
Location
Progress
Tender Overview
The opportunity is issued by the Department Of Health And Family Welfare for a Nucleic Acid Extraction Kit (Diagnostic Purpose) to be supplied in North Delhi, Delhi. The tender specifies kit details related to type of kit, isolation technology, kit compatibility, and pack size (number of reactions per pack). Key compliance requirements include Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended, along with a valid Medical Device license. The bidder must provide OEM authorization and specific documentation for imported or locally supplied kits. A notable clause allows quantity variation up to 50% during and after contracting, with delivery timeframes anchored to the original schedule. Unique requirements emphasize post-award service and material testing.
- Organization: Department Of Health And Family Welfare
- Location: North Delhi, Delhi
- Product category: Nucleic Acid Extraction Kit (Diagnostic Purpose)
- Key differentiator: mandatory regulatory compliance and OEM authorization
Technical Specifications & Requirements
- Type of Kit: defined by kit name in title
- Isolation Technology: specified feature set to be demonstrated
- Kit Compatibility: must align with existing diagnostic workflows
- Number of Reactions per Pack: explicit quantity per kit
- Certifications: Drugs and Cosmetic Act 1940 and MDR 2017 compliance; Medical Device license validity
- Shelf Life: required residual shelf life at delivery
- Packaging & Documentation: include OEM authorization and material test certificates; MII local content certificate; technical brochure
- Supply Scope: bid price to include all costs; post-award service expectations
- OEM/Imported Products: if imported, Indian registered office for after-sales support
Terms, Conditions & Eligibility
- Scope of Supply: Only supply of goods (no installation) with option to increase quantity up to 50% during contract and additional delivery time formula
- Documentation: OEM authorization, MII local content certificate, technical brochure, bid security declaration
- Certificates: Material Test Certificate to be provided with supply; buyer lab to assess
- EMD/Financials: EMD amount not disclosed in available data; ensure compliance with bid terms
- Delivery & Payment: delivery period linked to delivery order dates; payment terms to be as per contract; extended delivery rules apply for option exercise
- Eligibility: imported products require OEM presence in India for after-sales support; non-submission may lead to rejection
Key Specifications
-
Type of Kit: nucleic acid extraction kit for diagnostic use
-
Isolation Technology: specified by kit; must meet assay requirements
-
Kit Compatibility: compatible with standard diagnostic platforms
-
Number of Reactions per Pack: per tender detail
-
Certifications: Drugs and Cosmetic Act 1940; MDR 2017
-
Licensing: valid Medical Device license issued in India
-
Shelf Life: residual shelf life upon delivery
-
Documentation: Material Test Certificate; OEM authorization; technical brochure; MII local content certificate
Terms & Conditions
-
EMD and financial documents must be provided as per bid terms
-
Delivery can be increased by up to 50% with contract-rate protection
-
Imported items require Indian OEM presence for after-sales support
Important Clauses
Payment Terms
Not disclosed in data; contract will specify schedule tied to delivery orders and acceptance
Delivery Schedule
Delivery period commences from the last date of original delivery order; extended time formula applies
Penalties/Liquidated Damages
Not specified here; refer to contract terms for LDs and extensions
Bidder Eligibility
-
OEM authorization from quoted item’s manufacturer
-
Registered Indian office for after-sales service (if imported)
-
Compliance with MDR 2017 and Drugs and Cosmetic Act 1940
Tender Data
Bid Details
Quantity
47
Bid Type
Two Packet Bid
Bid Validity
180 (Days)
Bid Type
Service
Evaluation
Total value wise evaluation
Inspection Required
No
Tech Clarification Time
3 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
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
Nucleic Acid Extraction Kit (Diagnostic Purpose) (Q2)
Delivery Details
Max Delivery Days
14
Delivery Locations
1
Delivery Cities
Central
Delivery Pincodes
110054
Delivery Locations
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| Raman Kumar | 110054,22 Shamnath Marg Civil lines | Central | Delhi | 110054 | - | 14 | - |
Authority Records
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Documents 3
GeM-Bidding-9836495.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
Categories
3
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Required Documents
GST registration certificate
PAN card
OEM authorization certificate specific to quoted item
Experience certificates in nucleic acid extraction kit supply
Material Test Certificate for supplied kit
Technical brochure/catalogue of quoted item
MII certificate for local content percentage
Bid Security Declaration on company letterhead
Technical Specifications
1 Item
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| PRODUCT SPECIFICATION | Type of Kit | Total Nucleic Acid Extraction Kit |
| PRODUCT SPECIFICATION | Isolation Technology | Spin Column (Silica Membrane Column) |
| PRODUCT SPECIFICATION | Kit Compatibility | Manual, Automated |
| PACKAGING | Number of Reactions / Tests per pack | 100 |
| 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 |
| 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 |
Frequently Asked Questions
Key insights about DELHI tender market
How to bid for the nucleic acid kit tender in North Delhi?
Bidders must submit OEM authorization, MII local content certificate, GST, PAN, and technical brochure; include Material Test Certificate with delivery. Ensure compliance with Drugs and Cosmetic Act 1940 and MDR 2017; provide a clear delivery plan and price for all costs.
What documents are required for this North Delhi kit tender?
Required documents include GST certificate, PAN card, OEM authorization for quoted item, technical brochure, MII certificate, Material Test Certificate, and bid security declaration. Additionally, provide experience certificates in nucleic acid extraction kit supply and financial statements if requested.
What standards must the nucleic acid kit meet for MDR 2017?
The kit must comply with MDR 2017 as amended and Drugs and Cosmetic Act 1940; ensure valid Medical Device license in India and maintain residual shelf life at delivery as specified by the tender terms.
What is the delivery flexibility for quantity under this tender?
The purchaser may increase or decrease quantity up to 50% of bid quantity at contract; delivery time is calculated from the last date of the original delivery order, with a minimum 30 days for additional time.
Is there a requirement for local content in the bid?
Yes, provide an MII certificate from the OEM indicating the percentage of local content; this is mandatory for eligibility and to validate local supply commitments within India.
What is the scope of supply for this tender?
Scope is solely the supply of nucleic acid extraction kits; no installation services are included; ensure kit compatibility with existing diagnostic workflows and provide all required documentation.
What is the role of material test certificates in this tender?
Material Test Certificates must accompany each supply; the buyer laboratory will evaluate the results, which will be the sole criterion for item acceptance within the contract framework.
What if imported kit suppliers fail to provide Indian after-sales support?
Imported items require the OEM to have a registered Indian office for after-sales service; absence may lead to bid rejection; ensure documentation proving Indian support capability is included.