GEM

Health and Family Welfare Department Delhi Digital Medical X-Ray Films Tender North West Delhi 110034 - MDR 2017 Compliance, IS 550/ISO 9001 2025

Bid Publish Date

28-Oct-2025, 3:35 pm

Bid End Date

18-Dec-2025, 4:00 pm

EMD

₹16,000

Latest Corrigendum Available

Progress

Issue28-Oct-2025, 3:35 pm
Corrigendum08-Dec-2025
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

16000

Category

Digital Medical X - Ray Films (V2)

Bid Type

Two Packet Bid

Key Highlights

  • MDR 2017 compliance mandatory for all supplied X-Ray films
  • ISO 9001 certification required for bidder or OEM
  • 25% quantity variation right with calculated delivery extension formula
  • Import OEM must have India-based registered office for after-sales support
  • Drug license under Drugs and Cosmetic Act 1940 required
  • Batch-wise MDR test reports and manufacturing unit certification required
  • GST invoice and GST portal payment confirmation to be uploaded
  • Minimum shelf life at delivery to consignee is specified

Categories 1

Tender Overview

The procurement by the Health and Family Welfare Department, Delhi, targets Digital Medical X-Ray Films (V2) for PAC Only in North West Delhi, 110034. The estimated value is not disclosed, but the bid requires an EMD of ₹16,000. Key product attributes include daylight loading, film size in inches, and printer compatibility. Mandatory MDR 2017 compliance, valid drug license under the Drugs and Cosmetic Act, and a manufacturing unit certification are specified. The tender emphasizes submission of all certifications and test reports at bid submission or with supplies. A notable clause is the option to increase/decrease quantity by up to 25% and a corresponding delivery extension formula, ensuring flexibility for fluctuating demand. The structure indicates a focus on compliant, transport-ready films suitable for medical imaging workflows.

Technical Specifications & Requirements

  • Categories: General features, Product information, Certification & Reports, Shelf life.
  • Product details: Daylight loading, Film Size (inch), Printer compatibility.
  • Standards & compliance: MDR 2017 compliance; valid drug license under Drugs and Cosmetic Act; manufacturing unit certification; batch-wise test reports per MDR; submission of certifications/licenses/test reports with bid or on delivery.
  • Shelf life: Shelf life from manufacture date (in months) and minimum shelf life at delivery.
  • Vendor requirements: ISO 9001 certification for bidder or OEM; OEM after-sales support in India for imported products.
  • Documentation: GST invoice upload on GeM; compliance proofs as per buyer requirement.

Terms & Eligibility

  • EMD: ₹16,000.
  • Delivery terms: Option clause allows up to 25% quantity adjustment; delivery period aligned to original timeline with extensions as per formula.
  • Risks & compliance: Workmen compensation, insurance, and safety for high voltage work; termination rights if terms are breached; GST payment proof uploaded during invoice generation.
  • Documentation: ISO 9001 certificate; OEM authorization for imported items; drug license validity; batch test reports; all licenses/test reports to be submitted as required.

Key Specifications

  • Digital Medical X-Ray Films (V2) for PAC Only

  • Daylight loading capability

  • Film size in inches (exact dimension not specified)

  • Printer compatibility with standard radiology printers

  • MDR 2017 compliance and MDR batch test reports

  • Valid drug license under Drugs and Cosmetic Act 1940

  • Manufacturing unit certification

  • Shelf life from date of manufacture; minimum shelf life at delivery

Terms & Conditions

  • EMD amount of ₹16,000 required with bid submission

  • Delivery terms allow ±25% quantity variation at contract award

  • ISO 9001 certification mandatory for bidder or OEM

Important Clauses

Payment Terms

GST invoice must be uploaded on GeM; payment terms aligned with purchase order; GST portal confirmation required

Delivery Schedule

Delivery period tied to original order date; if option exercised, additional time determined by (Increased quantity / Original quantity) × Original delivery period, minimum 30 days

Penalties/Liquidated Damages

Vendor may be terminated for non-delivery or non-compliance; penalties via LD for defective material as per buyer terms

Bidder Eligibility

  • Must meet MDR 2017 compliance for medical device materials

  • ISO 9001 certification holder or OEM

  • Registered Indian office for after-sales support (for imported items)

Past Similar Tenders (Historical Results)

5 found

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Posted: 19 April 2025
Closed: 3 May 2025
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Posted: 2 December 2025
Closed: 12 December 2025
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Posted: 19 January 2025
Closed: 29 January 2025
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Posted: 15 July 2025
Closed: 25 July 2025
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Posted: 6 August 2025
Closed: 18 August 2025
GEM

Technical Specifications 2 Items

Item #1 Details

View Catalog
Category Specification Requirement
General Features Product Description Digital Medical X-Ray Films
Product Information Compatibility of Film with the Printer Konica
Product Information Daylight Loading Yes
Product Information Film Size (inch) 8 x 10 inch
Certification & Reports Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
Certification & Reports Availability of valid drug license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
Certification & Reports Manufacturing unit certification ISO:13485 (Latest)
Certification & Reports Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date Yes
Certification & Reports Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement Yes
Shelf Life Shelf Life from the date of manufacture (in months) 18, 24, 36 Or higher
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

GST registration certificate

2

PAN card

3

Experience certificates (similar medical imaging film supply)

4

Financial statements (as per tender terms)

5

EMD submission proof (₹16,000)

6

Technical bid documents demonstrating MDR 2017 compliance

7

OEM authorization (for imported products)

8

Manufacturing unit certification

9

Test reports for each supplied batch per MDR 2017

10

Drug license validity certificate under Drugs and Cosmetic Act

Corrigendum Updates

3 Updates
#1

Update

08-Dec-2025

Extended Deadline

18-Dec-2025, 4:00 pm

Opening Date

18-Dec-2025, 4:30 pm

#2

Update

28-Nov-2025

Extended Deadline

08-Dec-2025, 4:00 pm

Opening Date

08-Dec-2025, 4:30 pm

#3

Update

18-Nov-2025

Extended Deadline

28-Nov-2025, 4:00 pm

Opening Date

28-Nov-2025, 4:30 pm

Frequently Asked Questions

Key insights about DELHI tender market

How to bid for MDR 2017 compliant X-ray films in Delhi?

Bidders must meet MDR 2017 compliance, provide batch test reports, drug license validity, and manufacturing unit certification. Include ISO 9001 certificate, OEM authorization for imported items, and submit ₹16,000 EMD with GST-compliant invoice. Delivery terms may include up to 25% quantity variation.

What documents are required for digital X-ray film procurement in North West Delhi?

Submit GST registration, PAN, experience certificates for radiology film supply, financial statements, EMD proof, MDR-compliant technical documents, batch test reports, drug license under the Drugs and Cosmetic Act, and ISO 9001 certificate for bidder or OEM.

What are the technical specifications for X-ray film in this tender?

Films must be daylight-loadable, compatible with standard radiology printers, and available in specified film sizes (inches). Must meet MDR 2017 with batch test reports, and include shelf life data from manufacture date; minimum shelf life at delivery must be specified by buyer.

What are the delivery terms and extension provisions in this bid?

Original delivery period applies; option clause allows ±25% quantity change. If exercised, additional time equals (increased quantity/original quantity) × original delivery period, with a minimum of 30 days; delivery can be extended to the original period during option usage.

What is the EMD amount and payment procedure for this tender?

EMD is ₹16,000. Invoices must be uploaded as GST-compliant on GeM, and payment is contingent on supplying required certifications and test reports; ensure GST portal payment confirmation is available at submission.

What standards and certifications are mandatory for bidders in this tender?

Mandatory MDR 2017 compliance, ISO 9001 certification for bidder or OEM, manufacturing unit certification, and batch-wise MDR test reports; imported items require an Indian office for after-sales support and OEM authorization.

Is a valid drug license required for the X-ray film tender in Delhi?

Yes, a valid drug license under the Drugs and Cosmetic Act 1940 and Rules thereunder is required; certification must be available at bid submission or delivery as per buyer requirements, with test reports for each batch per MDR.

What documents prove compliance for bid submission in this procurement?

Submit MDR compliance certificates, batch test reports, drug license, ISO 9001 certificate, manufacturer/OEM authorization, manufacturing unit certificate, GST invoice, and EMD proof; ensure all documents are up-to-date and verifiable at bid submission.