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Bharat Heavy Electricals Limited IS 10258 Syringes Tender 2026 Human Use BHEL procurement

Bid Publish Date

13-Jun-2026, 10:22 am

Bid End Date

23-Jun-2026, 2:00 pm

Location

BHOPAL , MADHYA PRADESH

Progress

Issue13-Jun-2026, 10:22 am
AwardPending
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Quantity

600

Bid Type

Two Packet Bid

Key Highlights

  • IS 10258 (Part 1) compliance for single-use sterile syringes
  • MDR 2017 and valid Medical Device license required
  • Advance sample approval: 2 samples due within 7 days of award; potential deviations trigger rework or termination
  • 90-day payment term after CRAC issuance and online bill submission
  • GST invoicing: required GST invoice copy and GST portal confirmation
  • No BOQ items; emphasizes strict product specs and regulatory standards

Categories 2

Tender Overview

Bharat Heavy Electricals Limited (BHEL), operating under the Department of Heavy Industry, seeks supply of Single Use Sterile Hypodermic Syringes for Human Use conforming to IS 10258 (Part 1). The procurement involves syringes with embedded needles, needle caps or shields, and nominal syringe capacities specified in the BoQ terms (pack quantities and residual shelf life to be confirmed). The package demands MDR 2017 compliance and a valid medical device license from a competent authority. The project scope includes advance sample approval before bulk manufacturing, with 2 preliminary samples required within 7 days of award and modification handling as per buyer’s feedback. Delivery terms hinge on approval timing; the buyer reserves the right to re-fix delivery without LD if there are delays in sample approval. This tender emphasizes compliance with regulatory standards and post-approval batch consistency. The lack of BOQ items indicates a focused, specification-driven purchase rather than bulk cataloging and underscores unique quality-control milestones and payment terms via GeM.

Technical Specifications & Requirements

  • Product category: Single-use sterile hypodermic syringes for human use, with needles included and needle cap/shield for protection.
  • Nominal capacity: As per specific model in tender; ensure accurate ml rating.
  • Packaging: Number of pieces per pack as defined in the tender; verify packaging integrity.
  • Shelf life: Specify residual shelf life applicable to the lot.
  • Certifications: Compliance to Drugs and Cosmetic Act 1940 and MDR 2017; include valid Medical Device license.
  • Additional: Confirm that the device is IS 10258 (Part 1) compliant and suitable for human use.
  • All sample testing and approval to be completed prior to bulk manufacturing; 2 samples required within 7 days of award; modifications per buyer feedback.
  • Failure to conform to contract specs may trigger fresh samples or contract termination at buyer’s discretion.
  • GST invoice submission and GST portal payment screenshots required in GeM portal.

Terms, Conditions & Eligibility

  • EMD details: Not disclosed in data; bidders should confirm latest GeM terms for security deposit.
  • Advance sample approval: 2 samples due within 7 days of award; any major deviations may lead to contract termination.
  • Payment terms: Payments to seller within 90 days of CRAC issuance and online bill submission.
  • Invoices: Submit 3 copies of tax invoices with original seal and sign along with GeM contract.
  • GST compliance: Upload scanned GST invoice and GST portal payment confirmation during GeM invoice generation.
  • Warranty/quality: Conformity to MDR 2017 and IS 10258 (Part 1) with suitable post-delivery support expectations.
  • Delivery risk: If buyer delays sample approval, delivery period may be re-fixed with no LD for the delay.
  • BOQ status: No items in BOQ; focus is on precise product specifications and regulatory compliance.

Key Specifications

  • Product: Single-use sterile hypodermic syringes for human use

  • Needle: Included; shield/cap present

  • Nominal capacity: specified per model (e.g., 1 ml, 2 ml, etc.)

  • Packaging: pieces per pack as per tender

  • Shelf life: residual shelf life to be declared

  • Certifications: Drugs and Cosmetic Act 1940; MDR 2017; valid Medical Device license

Terms & Conditions

  • Advance sample approval process with 2 samples within 7 days of award

  • 90 days payment term post CRAC; online bill submission mandatory

  • GST invoice submission and GST portal payment confirmation required

Important Clauses

Payment Terms

Payments within 90 days of CRAC issuance and online submission of bills; GeM portal invoicing required.

Delivery Schedule

Delivery period may be refixed with no liquidated damages if buyer delays sample approval.

Penalties/Liquidated Damages

Terminated contract possible for major deviations in approved samples; no explicit LD mentioned until approval outcome.

Bidder Eligibility

  • Experience in supplying sterile medical devices (hypodermic syringes) to government entities

  • Valid Medical Device license and IS 10258 (Part 1) compliance

  • GST registration and financial stability documentation

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Single Use Sterile Hypodermic Syringes for Human Use Conforming to IS 10258 (Part 1) (Q2)

Authority Records

MINISTRY OF HEAVY INDUSTRIESHEAVY INDUSTRY DEPARTMENT

BID & GeM Expert Consultancy

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

Bid Preparation GeM Registration Document Filing

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Documents 5

GeM-Bidding-9463806.pdf

Main Document

CATALOG-Specification-1

CATALOG 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
PRODUCT INFORMATION Needle included Yes
PRODUCT INFORMATION Syringe type based on number of pieces Three Piece Syringe (Barrel and Piston, plunger and plunger stopper are two separate components of different materials)
PRODUCT INFORMATION Needle cap or shield to protect the needle Yes
PRODUCT INFORMATION Nominal Capacity of Syringe (ml) >2 - 5
PACKAGING Number of pieces in a Pack 100
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
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

PAN card

3

Experience certificates for similar medical device supply

4

Financial statements (as required by procurement)

5

EMD/Security deposit documentation (if applicable)

6

Technical bid documents confirming IS 10258 (Part 1) compliance

7

OEM authorization or manufacturer credentials for hypodermic syringes

8

Medical Device license copy from competent authority

Frequently Asked Questions

How to bid for IS 10258 syringes tender in India 2026

Bidders must meet eligibility criteria including IS 10258 (Part 1) compliance, MDR 2017 adherence, and a valid Medical Device license. Prepare GST registration, PAN, financials, and OEM authorizations. Submit 2 advance samples within 7 days of award, and ensure 90-day payment terms post CRAC.

What documents are required for the BHEL syringes procurement

Submit GST invoice with GST portal payment confirmation, PAN, experience certificates for similar supply, Medical Device license, technical bid proving IS 10258 compliance, OEM authorization, and financial statements. Include 3 copies of tax invoices with contract when delivering.

What standards govern the sterile syringe bid in GeM

Tenders require compliance with IS 10258 (Part 1) for human-use syringes and adherence to the Drugs and Cosmetic Act 1940 plus MDR 2017 amendments. A valid medical device license from the competent authority is mandatory for participation.

When is payment to suppliers for this GeM syringe contract

Payments are issued within 90 days of the issue of the Consginee Receipt-cum-Acceptance Certificate (CRAC) and online submission of bills. This supersedes prior timelines and requires GeM bill submission readiness.

What are the advance sample requirements for this tender

Bidders must supply 2 advance samples within 7 days of award. The buyer will approve or provide modifications within 7 days; nonconformity can lead to contract termination or request for fresh samples.

What licenses are required for syringes under this procurement

A valid Medical Device license for the product and compliance with the MDR 2017 are required, along with IS 10258 (Part 1) certification and documentation proving regulatory clearance.

What is the impact of sample approval delays on delivery

If the buyer delays sample approval, the delivery period is refixed and no liquidated damages apply for the delay attributed to sample clearance, preserving contract timelines post-approval.

What packaging and shelf-life details are expected

Packaging must specify number of pieces per pack and indicate residual shelf life. Ensure the product packaging preserves sterility until the point of use and aligns with MDR and IS 10258 packaging norms.

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