GEM

BHEL Dengue Malaria Typhoid Rapid Test Kits Tender 2025 – Medical Device MDR 2017 Compliance

Posted

22 Oct 2025, 05:18 pm

Deadline

01 Nov 2025, 06:00 pm

Location

HARIDWAR , UTTARAKHAND

Progress

Issue22 Oct 2025, 05:18 pm
AwardPending
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Quantity

240

Bid Type

Two Packet Bid

Tender Overview

Bharat Heavy Electricals Limited (BHEL) seeks suppliers for Point of Care Rapid Test Kits for humans, covering Dengue, Malaria, Typhoid and related illnesses. The procurement involves rapid test kits with defined packaging and inclusion of positive/negative controls. Compliance to the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, as amended, and possession of a valid Medical Device license are mandatory. Payment terms align with MSME categories: Micro & Small Enterprises paid within 45 days, Medium Enterprises within 60 days, and Non‑MSMEs within 90 days after receipt and acceptance. There is a risk mitigation framework for contract breaches, including 10% security instrument encashment and potential suspension of business dealings for non-performance. This tender emphasizes regulatory compliance and supplier integrity within BHEL’s supply chain.

Technical Specifications & Requirements

  • Product category: Point of Care Rapid Test Kits for humans (Dengue, Malaria, Typhoid & others)
  • Test kit features: Type of test kit, Detection type, Sample type, Result time
  • Packaging: Each pack should include positive and negative controls
  • Certifications: Drugs and Cosmetic Act 1940, Medical Device Rules 2017 (as amended), valid Medical Device license
  • Compliance: Product must be MDR 2017 compliant and ISI-like quality controls may be implied through license requirements
  • Delivery/installation details: Not specified; focus remains on regulatory compliance and license validity
  • Manufacturer requirements: OEM authorization and traceable supply chain are implied by compliance clauses

Terms, Conditions & Eligibility

  • EMD details: Not specified in available data
  • Payment terms: MSME-based timelines as described above
  • Breach remedies: 10% encashment of security instruments; liquidated damages and debarment applicable per contract
  • Anti‑corruption: Suspension guidelines for non‑performing suppliers; conflict of interest provisions apply
  • Documentation: GST, PAN, Medical Device license, product certifications, and quality compliance records are implied prerequisites

Key Specifications

  • Point of Care Rapid Test Kits for humans covering Dengue, Malaria, Typhoid & Others

  • In-pack requirements: positive and negative controls with each pack

  • Result time and sample type details to be explicitly specified by bidder

  • Regulatory standards: Drugs and Cosmetic Act 1940; MDR 2017 with amendments

  • Licensing: Valid Medical Device license issued by competent authority

  • Certification compatibility: MDR 2017 compliant product with necessary approvals

Terms & Conditions

  • EMD: Not specified in tender data; expect explicit requirement in full terms

  • Payment: MSME-based timelines (45/60/90 days) after receipt & acceptance

  • Regulatory: Compliance with Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license

Bidder Eligibility

  • Demonstrated experience in supplying medical rapid test kits

  • Valid Medical Device license for the product (competent authority)

  • Compliance with Drugs and Cosmetic Act 1940 and MDR 2017

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Type of Test Kit H.Pylori Antibody (IgM/IgG/IgA) Rapid Test Kit
PRODUCT INFORMATION Detection Type Qualitative
PRODUCT INFORMATION Sample Type Whole Blood, Serum and Plasma
PRODUCT INFORMATION Result Time ≤ 15 minutes, ≤ 30 minutes
PRODUCT INFORMATION Positive and negative controls provided with each pack of kit Yes, No
PACKAGING Number of Tests per Pack 10 Tests, 20 Tests, 25 Tests, 30 Tests, 40 Tests, 50 Tests
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

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Required Documents

1

GST registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates for similar supply

4

Financial statements (latest)

5

EMD/Security deposit documentation (if required in full terms)

6

Technical bid documents demonstrating MDR 2017 compliance

7

OEM authorizations or confirm OEM relationship for test kits

8

Medical Device license and related product certifications

Frequently Asked Questions

How to bid for BHEL rapid test kit tender 2025 in India

Bidders must meet eligibility criteria, submit GST, PAN, and financials, and provide Medical Device license proof. Ensure MDR 2017 compliance and Drugs and Cosmetic Act adherence. Include OEM authorizations and technical compliance documents; follow MSME payment terms and security deposit requirements as stated.

What documents are required for MDR 2017 compliant test kits in this tender

Prepare GST registration, PAN, company financials, experience certificates for similar supplies, a valid Medical Device license, OEM authorization, and technical bid detailing product type, test kit detection, sample type, and result time. Include positive/negative controls information per pack.

What are the regulatory standards for the test kits in this procurement

Products must comply with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, with a valid Medical Device license from the competent authority. Bidders should demonstrate MDR 2017 compliance and maintain license validity for the offered test kits.

What is the MSME payment timeline for this BHEL bid 2025

MSME vendors are paid within 45 days for Micro & Small Enterprises, 60 days for Medium Enterprises, and 90 days for Non-MSMEs after receipt and acceptance of material, ensuring timely cash flow per government policy.

Which product details are required in the tender for rapid test kits

Provide product type, detection method, sample type, and clear result time along with packaging details confirming positive and negative controls per pack. Ensure the kit specifications align with MDR 2017 and licensing requirements.

What penalties exist for breach of contract in this tender

BHEL enforces a 10% encashment of security instruments for breaches when available, with remaining recovery from other financial remedies. Liquidated damages, debarment, and contract termination may apply per the contractual terms.

Are OEM authorizations mandatory for the rapid test kit supply

Yes. OEM authorization or an explicitly stated manufacturer relationship is required to establish supply legitimacy, along with MDR 2017 compliance, Medical Device license, and product certifications to ensure traceability and quality.

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