GEM

NEIGRIHMS Blood Glucose Test Strips Tender Meghalaya – MDR 2017 Compliance, ISO 9001, EMD ₹37500 2025

Posted

28 Oct 2025, 10:39 am

Deadline

21 Nov 2025, 02:00 pm

EMD

₹37,500

Progress

Issue28 Oct 2025, 10:39 am
AwardPending
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Quantity

250000

Bid Type

Two Packet Bid

Key Highlights

  • • Explicit MDR 2017 compliance requirement with all amended dates
  • • Drug license validity under Drugs and Cosmetic Act 1940 and rules
  • • ISO 9001 certification required for bidder or OEM
  • • OEM authorization and Manufacturer Authorization for distributors
  • • End User Certificate to be provided in buyer's format
  • • Post-bid requirement to supply 150 glucose monitors and 150 lenset pens
  • • Make in India authorisation certificate mandatory
  • • Material test certificate and batch test reports to accompany supplies

Categories 1

GLUCOSE ANALYZERS

Tender Overview

Organization: North Eastern Indira Gandhi Regional Institute Of Health And Medical Sciences (neigrihms) under the Department of Health And Family Welfare. Product category: Blood glucose test strips (General medical device category) with MDR 2017 compliance. EMD: ₹37,500. Location: North East India (NEIGRIHMS campus context) with supply scope to government facilities. Estimated value not disclosed; scope includes complete supply of goods and required certificates. A key differentiator is strict MDR-2017 conformity, drug license validity, and batch-wise test reports. The buyer requires end-user certificate alignment and 150 glucose monitors plus 150 lenset pens as post-award installation items. Unique clauses include OEM authorization, Make in India certification, and ISO 9001 compliance. This tender emphasizes complete documentation with bid submission and on-delivery certification.

Technical Specifications & Requirements

  • Product: Blood glucose test strips; compatible with widely available glucometers in the market.
  • Enzyme / Chemistry: Enzyme used in the strip specified in product information.
  • Certifications & Reports: MDR 2017 compliance; valid drug license under Drugs and Cosmetics Act 1940; Manufacturing unit certification; batch test reports per MDR.
  • Packaging & Shelf Life: Packing type; minimum shelf life from manufacture date; minimum shelf life on delivery; shelf life after first opening.
  • Documentation: Submission of all licenses, test reports, and certifications with bid or at supply time; OEM/Manufacturer authorization where applicable.
  • Additional Requirements: IS/Quality framework (ISO 9001), BIS/type test/certificates as per product spec; material test certificate to be uploaded with bid; in case of imports, Indian registered office for after-sales service.
  • End-User and Post-Sale: End User Certificate as per buyer format; post-award provision for 150 glucose monitors and 150 lenset pens.

Terms, Conditions & Eligibility

  • EMD: ₹37,500 via online/ Demand Draft (as per bid document).
  • Experience & Turnover: Experience certificate for supplying similar items to government or PSU; minimum average annual turnover criteria as per bid document (three-year period); audited statements or CA certificates to be uploaded.
  • Compliance: ISO 9001 certification for bidder or OEM; OEM authorization for imported products with Indian after-sales office; BIS/license and type tests as required; material test certificate to be supplied with supply.
  • Delivery & End User: End User Certificate from buyer to be provided in buyer format; scope includes only supply of goods and related certifications; successful bidder must supply 150 glucose monitors and 150 lenset pens along with required MT certificates.
  • Warranty & Penalties: Not explicitly stated in ATC; standard supply-quality covenants apply with lab test-based acceptance.
  • Additional: MSME/NSIC EMD exemption certificate if applicable; Make in India authorization; no liquidation or bankruptcy status; end-to-end documentation must be uploaded with bid submission.

Key Specifications

  • Blood glucose test strips

  • Enzyme used per product information

  • Compatible with market glucometers

  • MDR 2017 compliance

  • Drug license under Drugs and Cosmetics Act 1940

  • Manufacturing unit certification

  • Batch test reports for each supplied batch

  • Shelf life: months from manufacture date

  • Minimum shelf life on delivery; post-opening shelf life

  • 150 glucose monitors and 150 lenset pens post-award

Terms & Conditions

  • EMD of ₹37,500 required; payment terms per ATC

  • ISO 9001 certification required for bidder or OEM

  • End User Certificate in buyer format and OEM authorization

  • MDR 2017 compliance with batch test reports

  • Make in India authorization; drug license validity

  • Turnover evidence and experience certificates

Important Clauses

Payment Terms

EMD ₹37,500; payment terms aligned to supply milestones per bid conditions

Delivery Schedule

Delivery of goods with required shelf life; post-award supply of 150 glucose monitors and 150 lenset pens

Penalties/Liquidated Damages

Penalties to be specified in bid documents; acceptance based on in-lab Material Test Certificate results

Bidder Eligibility

  • Experience in supplying similar medical devices to government/PSU

  • Demonstrable turnover as per bid document for last 3 financial years

  • ISO 9001 certification for bidder or OEM; Make in India authorization if applicable

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
General Features Product Description Blood Glucose Test Strip
Product Information Enzyme Used in The Strip Glucose Oxidase, Glucose Dehydrogenase(GDH)
Product Information Compatible with Glucometers available in market No, Yes
Packaging Type of Packing Packed in Air Tight Container, Individually Packed Test Strip in Foil Pouch
Certifications & Reports Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
Certifications & 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
Certifications & Reports Manufacturing unit certification ISO:13485 (Latest)
Certifications & Reports Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date Yes
Certifications & 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 in months from the date of manufacture 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
Shelf Life Minimum shelf life after first opening of the pack 3 Months or more

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates for similar government/PSU supply

4

Audited financial statements or CA certificate for turnover

5

EMD submission proof (₹37,500)

6

ISO 9001 certification proof ( bidder or OEM )

7

BIS license and type test certificates as per product specification

8

Drug license under Drugs and Cosmetic Act 1940

9

Manufacturing unit certification

10

Manufacturer/ OEM authorization or agency authorization

11

Batch test reports per MDR 2017

12

End User Certificate (buyer format requirement)

Frequently Asked Questions

How to bid for MDR 2017 glucose test strips tender in northeast?

Bidders must submit EMD ₹37,500, ISO 9001 certificates, MDR 2017 compliance, drug license, batch test reports, and OEM authorization. Provide experience certificates for similar government supply and turnover proof for last 3 years. Include End User Certificate in the buyer format and Make in India authorization if applicable.

What documents are required for neigrihms glucose strips tender 2025?

Required documents include GST, PAN, experience certificates, audited turnover or CA certificate, EMD proof, MDR batch test reports, drug license under Drugs and Cosmetics Act, manufacturing unit certificate, ISO 9001 proof, BIS/type test certificates, and OEM authorization where applicable.

What are the technical specifications for MDR 2017 glucose strips?

Specifications mandate enzyme details per product information, compatibility with common market glucometers, shelf life from manufacture date, minimum shelf life on delivery and after opening, plus batch test reports and material test certificates at delivery.

When is the EMD and payment terms for this tender?

EMD is ₹37,500 to be submitted with bid; payment terms follow the buyer's ATC, typically milestone-based after delivery and acceptance, subject to lab test results and contract clauses.

What is required for OEM authorization in this bid?

Bidder must furnish OEM/Original Service Provider authorization with name, designation, address, email, and phone. If importing, establish Indian after-sales support with registered office as per ATC requirements.

What post-award items are included with glucose strips supply?

Successful bidders must supply 150 glucose monitors and 150 pen for lenset, in addition to the strips, with accompanying batch/test documentation and any required warranty/after-sales support per bid terms.

What standards and licenses are mandatory for bidder eligibility?

Mandatory standards include MDR 2017 compliance, ISO 9001 certification, BIS/type tests where specified, and valid drug license under the Drugs and Cosmetics Act. Provide all certificates at bid submission and with delivery.

What is the scope of supply for this neigrihms tender?

Scope is limited to supply of goods with all cost components included in the bid price; end-user compliance, documentation, and post-delivery validation as per buyer format are also required.