Uterine Balloon Tamponade Device (V2)
National Rural Health Mission (nrhm) State Health Society
Posted:
25 September 2025
Closed:
8 November 2025
GEM
GEM
Directorate Of Medical Education & Research Haryana Uterine Balloon Tamponade Device Tender 2026 MDR Compliant
Progress
Issue24-Jun-2026, 10:57 am
AwardPending
Quantity
100
Bid Type
Two Packet Bid
Key Highlights
- • Exact product: Bakri Uterine Balloon Tamponade Device (V2) with stated balloon capacity and inflation mechanism
- • Regulatory standards: MDR 2017 compliance; valid Drug/MED license; manufacturing unit certification
- • Documentation: mandatory submission of licenses, batch test reports, and OEM authorizations at bid/supply
- • Delivery terms: door-step delivery including labor; 25% quantity variation allowed during contract
- • Quality assurance: advance sample approval; per-batch test reports for MDR compliance
- • Disqualification risk: same IP address submissions may be disqualified
- • Award terms: 100 nos. required; no partial supply; single-source delivery obligations
Tender Overview
The Directorate Of Medical Education & Research, Haryana invites bids for a Uterine Balloon Tamponade Device (V2) under the Medical Equipment procurement category. The tender focuses on 100 Bakri balloons with door-step delivery and full supplier responsibility for installation labor. Key compliance includes MDR 2017, drug/medical device licenses, manufacturing unit certification, and batch test reports. The buyer reserves a 25% quantity variation and extended delivery timelines, with delivery starting post-order. This tender requires advance samples for buyer approval and strict adherence to packaging, shelf life, and certification norms. The opportunity is location-specific to Haryana, with a strong emphasis on device safety and regulatory compliance.
Technical Specifications & Requirements
- Product: Uterine Balloon Tamponade Device (Bakri balloon variant) (V2)
- Quantity: 100 nos. (part-supply not allowed; sole delivery obligation)
- Certifications: MDR 2017 compliance; valid Drugs/Medical Device License; Manufacturing Unit Certification; batch-wise test reports; submission of all licenses and test reports at bid/supply.
- Packaging & Shelf Life: specified packing type; minimum shelf life at delivery; advance sample required before supply commence
- Delivery & Logistics: door-step delivery including labor; option clause allows up to 25% quantity increase/decrease at contracted rates; delivery time adjusted per clause; single-source delivery expectation
- Technical Features: balloon material, balloon capacity, inflation mechanism, syringe provided, connectors, tube length, and any other listed features in the MDR/compliance section
- QA & Documentation: advance sample, test reports for each batch, and all required certifications to buyer at bid or supply time
- Special Conditions: two or more bidders from same IP address may be disqualified; Bidder must comply with all ATC terms
Terms, Conditions & Eligibility
- EMD/Security: not explicitly stated; bidders should prepare as per MDR-based tender norms
- Delivery: delivery period and option-based extensions governed by 25% quantity variation clause; delivery starts after last date of original delivery order
- Payment: standard government procurement terms; ensure clear payment milestones within supply terms
- Documentation: GST, PAN, experience certificates, financial statements, EMD proof, OEM authorizations, technical compliance certificates, batch test reports
- Quality & Compliance: MDR 2017 compliance; drug/medical device license; manufacturing unit certification; batch test reports per MDR
- Penalties: apply LDs for delays per option clause; ensure adherence to delivery windows and 30-60 day payment cycles as per buyer terms
- Warranty/Support: manufacturer warranty expectations and post-sales support per device category
- Eligibility: must meet technical capability to supply Bakri balloons with door-step delivery and labelling per MDR
Key Specifications
-
- Product: Uterine Balloon Tamponade Device (Bakri balloon variant) (V2)
-
- Quantity: 100 nos. (no part-supply)
-
- Standards: MDR 2017 compliance; valid Drugs & Cosmetics Act license
-
- Certifications: Manufacturing unit certification; batch test reports per MDR
-
- Shelf life: minimum shelf life from date of manufacture; specify months
-
- Packaging: Type of packing as specified; comply with buyer requirements
-
- Delivery: door-step delivery with labor; option clause permits up to 25% quantity variation
Terms & Conditions
-
Option Clause: 25% quantity variation during contract
-
Door-step delivery including labor with sole supplier responsibility
-
Advance sample required for buyer approval before commencement
Important Clauses
Payment Terms
Standard procurement terms; verify milestone payments post-delivery and submission of compliant batch reports
Delivery Schedule
Delivery begins after the original last delivery date; extended time proportional to quantity variation, minimum 30 days
Penalties/Liquidated Damages
LDs apply for delays per option clause; ensure timely delivery and regulatory compliance
Bidder Eligibility
-
Experience in supplying medical devices under MDR with batch testing
-
Demonstrated capability for door-step delivery and installed labor
-
Compliance with MDR 2017, Drug/Medical Device License, and manufacturing certifications
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Uterine Balloon Tamponade Device (V2) (Q2)
Authority Records
MEDICAL EDUCATION AND RESEARCH DEPARTMENT
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Bid Preparation
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Documents 3
GeM-Bidding-9512526.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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Tender Results
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Technical Specifications
1 Item
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| GENERAL FEATURES | Product Description | Uterine Balloon Tamponade Device |
| GENERAL FEATURES | Usage | Single Use |
| GENERAL FEATURES | Sterility | Sterile |
| PRODUCT INFORMATION | Balloon Material | Medical Grade Thermoplastic Elastomer (TPE) |
| PRODUCT INFORMATION | Balloon Capacity | 1000 ml to 2000 ml |
| PRODUCT INFORMATION | Inflation Mechanism | Manual Syringe Inflation |
| PRODUCT INFORMATION | Syringe Provided | Yes |
| PRODUCT INFORMATION | Connector provided | Yes |
| PRODUCT INFORMATION | Tube Length | 50 cm or longer |
| PRODUCT INFORMATION | Other Features | Allows for Contraction and Retraction of Uterus, Provides Visual Indicator, Allows for Intra-Uterine Pressure Control, Free Flow Open System |
| PACKAGING | Type of Packing | Moisture Proof Packing |
| CERTIFICATIONS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Availability of valid drug/medical device 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 | Manufacturing unit certification | ISO:13485 (Latest) |
| CERTIFICATIONS | Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement | Yes |
| SHELF LIFE | Shelf life in months from the date of manufacture | 24 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 |
| ADVANCE SAMPLE | Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding | Yes |
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Required Documents
1
GST registration certificate
2
PAN card
3
Experience certificates for prior similar medical device supplies
4
Financial statements for last 2-3 years
5
EMD payment proof (if applicable)
6
Technical bid documents demonstrating MDR compliance
7
OEM authorization/cactory authorization for Bakri balloon devices
8
Manufacturing unit certification
9
Drug/medical device license validity
10
Batch-wise test reports for MDR 2017 certified devices
11
Proof of advance sample submission plan
Frequently Asked Questions
Key insights about HARYANA tender market
How to bid for the Bakri balloon device tender in Haryana 2026?
To bid for the Haryana Bakri balloon device tender, submit MDR-compliant certificates, drug license, manufacturing certificate, and batch test reports. Include OEM authorization, GST, PAN, financials, and advance sample plan. Ensure 100 nos. quantity and door-step delivery with labor obligations are met within the option clause terms.
What documents are required for Haryana DMER medical device tender?
Required documents include GST certificate, PAN card, experience certificates for prior medical device supply, last 2-3 years financial statements, EMD proof, MDR compliance documents, batch test reports, manufacturing unit certification, OEM authorization, and advance sample submission plan for the device.
What certifications and standards must the Bakri balloon follow?
Bidders must provide MDR 2017 compliance, valid Drugs and Cosmetics Act license, manufacturing unit certification, and batch test reports per MDR. Ensure all certificates are current and submitted with bid or supply, with device specifications matching Bakri balloon V2 requirements.
What is the delivery mechanism for the Haryana medical device tender?
Delivery is door-step including labor, with sole supplier responsibility. An option clause allows ±25% quantity variation at contracted rates. Delivery period starts after the last date of the original delivery order; extended delivery time calculated per quantity adjustment, minimum 30 days.
What is the minimum shelf life requirement for the device?
Tenders require a minimum shelf life from the date of manufacture. Ensure the batch test reports reflect shelf life compliance and that products delivered meet or exceed the stated months until expiry at consignee delivery.
Are advance samples mandatory before commencing supply?
Yes. The buyer requires advance samples for approval prior to commencing supply. Prepare a sample submission plan with device specifications, packaging, and MDR-compliant labeling to expedite bid evaluation and supplier approval.
What are the payment terms for the Haryana Uterine Balloon Tamponade device contract?
Payment terms align with government procurement norms; verify milestone-based payments post-delivery and submission of MDR-compliant batch test reports. Ensure clear documentation for payment processing within the agreed 30-60 day framework and alignment with delivery milestones.
What is the scope of the 25% option clause in this tender?
The purchaser may increase or decrease the contracted quantity by up to 25% at the time of order and during the contract term at the same contracted rates. Delivery timelines adjust proportionally based on the extended quantity, with a minimum extension of 30 days.
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Documents 3
GeM-Bidding-9512526.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS