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Central Health Service Viral RNA Extraction Kit Tender Maharashtra 2026 MDR 2017 Compliance

Bid Publish Date

02-Jul-2026, 10:35 am

Bid End Date

13-Jul-2026, 11:00 am

EMD

₹40,000

Location

NEW DELHI , DELHI
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Progress

Issue02-Jul-2026, 10:35 am
AwardPending
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Quantity

10000

Bid Type

Two Packet Bid

Key Highlights

  • • Make in India authorization certificate required
  • • MDR 2017 compliance and valid medical device license mandatory
  • • EMD set at ₹40,000; supply-only contract with no service component
  • • Option clause permits ±50% quantity variation during contract
  • • End User Certificate and Integrity Pact mandatory
  • • GST handling: bidder bears GST; reimbursement as per actuals or lower rate
  • • Prior govt/PSU supply experience required with PO documentation
  • • Shelf life requirement to be verified at delivery

Categories 1

NUCLEIC ACID EXTRACTION KITS

Tender Overview

Central Health Service, Ministry of Health and Family Welfare seeks a Viral RNA Extraction Kit for nationwide deployment under the Department of Health and Family Welfare. The call specifies an EMD of ₹40,000 and a scope limited to the supply of Goods. Key terms include Make in India authorization, MDR 2017 compliance, and a requirement for an End User Certificate as per buyer policy. The tender emphasizes robust post-award integrity and GST compliance, with a flexible option clause allowing up to 50% quantity variation during contract execution. This procurement targets suppliers with prior govt/ PSU experience and a strong financial track record.

Technical Specifications & Requirements

  • Product category: Viral RNA Extraction Kit
  • Samples supported: Various samples from which viral RNA can be extracted
  • Isolation technology: As specified in product information
  • Sample volume for processing: Noted in kit specs
  • Elution volume: Detailed in kit specifications
  • Extraction process: Defined workflow in kit documentation
  • Time per batch: at least 24 minutes per extraction batch
  • Enhancement: Carrier RNA or enhancer buffer to increase eluted RNA quantity
  • Kit compatibility: Must align with standard lab workflows; exact compatibility not provided
  • Pack size: Number of tests/reactions per kit to be specified in bid
  • Certifications: MDR 2017 compliance and valid medical device license under the Drugs and Cosmetics Act
  • Shelf life: Minimum shelf life at delivery
  • These specifications indicate a need for vendor clarity on performance metrics and regulatory compliance.

Terms, Conditions & Eligibility

  • EMD: ₹40,000 to be submitted with bid
  • Experience: Demonstrated supply to Govt/PSU or renowned private entities with supply/purchase orders
  • MSME/NSIC exemption: If applicable, submit exemption certificate
  • Make in India authorization: Include valid authorisation certificate
  • Financial standing: No liquidation or bankruptcy; upload an undertaking
  • GST: Bidder responsible for GST; reimbursement as per actuals or lower rate
  • Integrity Pact: Signed copy to be uploaded
  • End User Certificate: Provided in buyer’s format if requested
  • Option clause: Purchaser may vary quantity by up to 50% at contract award or during execution
  • GST invoicing: Upload GST invoice and GST portal payment screenshot in GeM
  • Scope: Bid price must cover all costs for the supply of goods
  • Turnover: Minimum average annual turnover criterion as per bid document; evidence via audited statements or CA/Cost Accountant certificate

Key Specifications

  • Viral RNA Extraction Kit with capacity for multiple samples

  • Time per batch: at least 24 minutes

  • Carrier RNA or enhancer buffer mandatory

  • MDR 2017 compliance and Drugs and Cosmetic Act license

  • Minimum shelf life at delivery

  • Pack size defined per kit for number of tests/reactions

Terms & Conditions

  • EMD ₹40,000 required with bid submission

  • 50% quantity variation rights for purchaser

  • Make in India and MDR 2017 compliance mandatory

Important Clauses

Payment Terms

GST payable by bidder; reimbursement as actuals or lower rate; GST invoice and GST portal payment screenshot required with GeM submission

Delivery Schedule

Delivery period linked to contract; option to increase quantity up to 50% with extended delivery timelines calculated per clause

Penalties/Liquidated Damages

LD provisions to be as per GeM purchaser terms; specific LD rate not stated in data

Bidder Eligibility

  • Experience in supplying viral RNA extraction kits to Govt/PSU or reputed private organizations

  • Financial stability evidenced by audited statements or CA certificate

  • Make in India authorization and MDR 2017 compliance documents

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

Yes

Item Category

Viral RNA Extraction Kit (Q2)

Authority Records

MINISTRY OF HEALTH AND FAMILY WELFAREHEALTH AND FAMILY WELFARE DEPARTMENT

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End-to-end support — bid preparation, GeM registration, document filing & compliance by industry experts.

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Documents 5

GeM-Bidding-9527199.pdf

Main Document

GeM Category Specification

GEM_CATEGORY_SPECIFICATION

Other Documents

OTHER

Other Documents

OTHER

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Product Description Viral RNA Extraction Kit
PRODUCT INFORMATION Samples from which Viral RNA can be extracted Plasma, Serum, CSF, Urine, Other cell-free body fluids, Cell-culture supernatant, Nasopharyngeal swab, Oropharyngeal Swabs
PRODUCT INFORMATION Isolation Technology Silica Technology (Silica Membranes Column)
PRODUCT INFORMATION Sample volume for processing 25 µl - 300 µl
PRODUCT INFORMATION Elution volume 30 µl - 100 µl
PRODUCT INFORMATION Process of extraction Centrifugation
PRODUCT INFORMATION Time per batch (at least 24) extraction <60 Minutes Or higher
PRODUCT INFORMATION The kit should have carrier RNA or enhancer buffer to enhance quantity of eluted viral RNA Yes
PRODUCT INFORMATION Kit Compatibility Manual Platform
PACKAGING Pack Size of the Kit (Number of Test or Reactions) 50
CERTIFICATIONS Compliance with 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 defined under Drugs and Cosmetic Act 1940 and Rules there under as amended till date Yes
SHELF LIFE Minimum shelf life of the product at the time of delivery to the consignee 3/4 th of total shelf life

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Required Documents

1

BIDDER SUBMISSION documents as per Terms and Conditions: GST registration, PAN, audited financial statements or CA certificate on turnover, experience certificates for govt/PSU supply, MSME/NSIC exemption certificate (if applicable), Make in India authorization certificate, MDR compliance documents, medical device license, Integrity Pact signed copy, End User Certificate (buyer format if requested), bid security/payment details, GST invoice format samples

Frequently Asked Questions

Key insights about DELHI tender market

How to bid for viral RNA extraction kit tender in Maharashtra 2026?

Bidders must meet eligibility criteria, submit ₹40,000 EMD, provide govt/PSU supply certificates, Make in India authorization, and MDR 2017 compliance. Include End User Certificate if requested, Integrity Pact, GST details, and audited turnover. Ensure GeM GST invoice readiness and 50% quantity option awareness.

What documents are required for RNA kit tender submission in India?

Required documents include GST registration, PAN, audited financials or CA certificate indicating turnover, govt/PSU supply experience certificates, Make in India authorization, MDR compliance, medical device license, End User Certificate, signed Integrity Pact, EMD payment proof, and GST invoice examples.

What are the technical standards for the RNA extraction kit?

Standards include MDR 2017 compliance, valid medical device license under Drugs and Cosmetics Act, and kit compatibility with standard lab workflows. Ensure carrier RNA or enhancer buffer is included and time per batch is at least 24 minutes per extraction.

What is the EMD for the viral RNA kit procurement?

The EMD amount is ₹40,000. Submit payment proof with bid; EMD supports bid validity and supplier credibility; ensure GST invoices align with GeM processes and portal screenshots where required.

What delivery flexibility is allowed for quantity in this tender?

The purchaser may increase or decrease quantity up to 50% of the bid quantity at contract placement and during execution. Delivery time and scheduling adapt to extended periods using the option clause formulas outlined in terms.

What are the GST requirements for RNA kit bidding on GeM?

Bidder bears GST; reimbursement is as per actual rates or lower rate. Provide GST invoice and GST portal payment screenshot during GeM submission; ensure GST compliance across all bid materials.

What constitutes eligibility for govt/PSU RNA kit supply?

Eligibility requires prior govt/PSU or renowned private organization supply experience with PO documentation, financial stability proof, and adherence to MDR 2017 and Make in India certification; provide end-user certificate if requested.

What is the shelf life requirement for the RNA kit delivered?

Tenders require a minimum shelf life of the product at the time of delivery to consignee; verify expiry dates on batch lots and ensure replenishment plans align with delivery schedules.

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