Employees State Insurance Corporation BiPAP Full Face Mask Tender Gulbarga Karnataka 2017 MDR ISO 9001 2026
Bid Publish Date
29-Aug-2026, 12:44 pm
Bid End Date
12-Sep-2026, 1:00 pm
Location
Progress
Tender Overview
Organization: Employees State Insurance Corporation (ESIC) – Gulbarga, Karnataka. Product: BiPAP Full Face Mask (V2) for patient respiratory support. Scope: Supply of complete biometric mask components including soft cushion, forehead frame, headgear clips, squeeze elbows, ports (Vent, Nebulizer, Expiratory, Bronchoscopy), Luer lock caps, and swivel assembly. Delivery window: 15 days from PO issuance per ATC clause. Quality controls: MDR 2017 compliance, valid drug license under Drugs and Cosmetic Act, batch test reports, manufacturing unit certification. At least one mandatory step: advance sample before technical evaluation. Delivery flexibility: quantity may vary by ±25% during contract, with revised delivery timelines calculated per policy. Key differentiator: explicit requirement for infection-control single-layer cushion and built-in ventilation features. Overall value indicators: no estimate published; EMD details not disclosed in provided data.
Technical Specifications & Requirements
- Product category: General features and product information of a BiPAP full-face mask for medical use.
- Materials/standards: Non-toxic, medical-grade material; MDR 2017 compliance; ISO 9001 certification for bidder or OEM.
- Design features: Auto-adjustable mask, soft transparent frame, flexible winged forehead frame, light-weight durable frame, angular forehead support, headgear clips, squeeze-type elbow, single-layer infection-control cushion with cushion locking system.
- Ports & connectivity: Built-in vent port, air entrainment valve, universal nebulizer port, expiratory port, bronchoscopy port, Luer lock port caps, swivel assembly.
- Documentation: Availability of test reports per MDR 2017 for each batch; supply of all certifications at bid submission or with supplies; manufacturing unit certification; valid drug license.
- Shelf life: Minimum shelf life at delivery; shelf life from manufacture in months.
- Advance sample: Required prior to technical evaluation.
Terms, Conditions & Eligibility
- EMD/guarantee: EMD amount details not provided in the tender data.
- Delivery terms: Delivery within 15 days of PO; option to extend delivery time under quantity variation policy.
- Payment terms: Not specified in the data; procurement scope is supply-only.
- Experience & Certifications: ISO 9001 certification for bidder or OEM; MDR compliance; drug license under Drugs and Cosmetic Act; batch test reports; manufacturing unit certification.
- Bid requirements: Upload all required documents; advance sample submission mandatory; supplier must provide dedicated/ toll-free service support.
- Quantity flexibility: Up to ±25% variation during the contract period.
Key Specifications
-
- Product: BiPAP Full Face Mask (V2) for medical use
-
- Materials: Non-toxic, medical-grade material; single-layer cushion
-
- Standards: MDR 2017, ISO 9001
-
- Certifications: Drug license under Drugs and Cosmetic Act; Manufacturing unit certification
-
- Design/Dimensions: Auto-adjustable mask; soft, translucent frame; flexible winged forehead frame; lightweight and durable
-
- Ports: Built-in vent port; air entrainment valve; universal nebulizer port; expiratory port; bronchoscopy port; Luer lock caps; swivel assembly
-
- Shelf life: Minimum shelf life at delivery; shelf life from date of manufacture in months
-
- Sampling: Advance sample required before technical evaluation
Terms & Conditions
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Quantity may be increased or decreased up to 25% at contract award; delivery schedule adjusts accordingly
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Bidder must provide advance sample before technical evaluation for health-care utility
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ISO 9001 certification required for bidder or OEM; MDR 2017 compliance mandatory
Important Clauses
Payment Terms
Not disclosed in data; procurement is supply-only with delivery within 15 days from PO; confirmation of payment terms required in bid submission
Delivery Schedule
Delivery must commence within 15 days of issuance of purchase order; extended delivery time allowed per option clause with proportional calculation
Penalties/Liquidated Damages
Late delivery charges apply per GeM policy; specifics not provided; ensure compliance with schedule to avoid LDs
Bidder Eligibility
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Bidder or OEM must hold ISO 9001 certification
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Product must be MDR 2017 compliant and have valid drug license under Drugs and Cosmetic Act
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Advance sample required for technical evaluation
Tender Data
Bid Details
Quantity
650
Bid Type
Two Packet Bid
Bid Validity
180 (Days)
Bid Type
Service
Evaluation
Total value wise evaluation
Inspection Required
No
RA Qualification Rule
50% Lowest Priced Technically Qualified Bidders
Tech Clarification Time
2 Days
Preference & Exemptions
EMD Required
No
MII Purchase Preference
Yes
MII Preference Band
L1+20%
MSE Purchase Preference
Yes
MSE Preference Band
L1+15%
MSE Exemption/Relaxation
Yes
Startup Exemption/Relaxation
Yes
Bid Splitting Applied
No
Requirements
Min. Avg. Annual Turnover
1
OEM Avg. Turnover
7
Past Performance
20 %
Experience Required
2 Year (s)
Arbitration Clause
No
Mediation Clause
No
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
BiPAP Full Face Mask (V2) (Q2)
Advisory Bank
State Bank of India
ePBG Percentage
5%
ePBG Duration (Months)
15
Pre-Bid & Qualification
Pre-Bid Date
24-08-2026 10:00:00
Pre-Bid Venue
ESIC Medical College & Hospital, Sedam road, Kalaburagi.585106
Delivery Details
Max Delivery Days
220
Delivery Locations
1
Delivery Cities
Kalaburagi
Delivery Pincodes
585106
Delivery Locations
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| HUSNA K P | 585106,ESIC Medical College and Hospital Sedam Road, Kalaburagi-585106 | Kalaburagi | Karnataka | 585106 | - | 220 | - |
Authority Records
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Documents 3
GeM-Bidding-9749497.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
Categories
1
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Required Documents
GST registration certificate
PanCard
Experience certificates for similar medical device supply
Financial statements (last 3 years)
EMD/Security deposit details (if disclosed in terms)
Technical bid documents demonstrating MDR 2017 compliance
OEM authorization certificates (if bidding as OEM partner)
ISO 9001 certification (bidder or OEM)
Drug license under Drugs and Cosmetics Act 1940
Manufacturing unit certification
Test reports for each batch (MDR 2017 compliant)
Technical Specifications
1 Item
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| GENERAL FEATURES | Product Description | BiPAP Full Face Mask |
| GENERAL FEATURES | Patient category | Adult |
| GENERAL FEATURES | Usage | Single-Use |
| GENERAL FEATURES | Sterility | Sterile, Non-sterile |
| GENERAL FEATURES | Autoclavable | Yes, No |
| PRODUCT INFORMATIONS | Non-toxic, Medical grade material | Yes |
| PRODUCT INFORMATIONS | Material of Mask | Silicon Rubber and TPE (Thermoplastic Elastomer) |
| PRODUCT INFORMATIONS | Size | Medium |
| PRODUCT INFORMATIONS | Auto adjustable mask | Yes |
| PRODUCT INFORMATIONS | Soft, smooth and transparent frame | Yes |
| PRODUCT INFORMATIONS | Flexible, winged forehead frame | Yes |
| PRODUCT INFORMATIONS | Light weight, strong, durable and flexible frame to stabilize the mask on the face | Yes |
| PRODUCT INFORMATIONS | Angular forehead support | Yes |
| PRODUCT INFORMATIONS | Headgear clips for easy to grip for attaching or detaching | Yes |
| PRODUCT INFORMATIONS | Squeeze type elbow for easy attachment and detachment from frame | Yes |
| PRODUCT INFORMATIONS | Single layer cushion, infection control | Yes |
| PRODUCT INFORMATIONS | Cushion locking system | Built-in |
| PRODUCT INFORMATIONS | Built-in Vent port for dispersing the air gently and quietly | No |
| PRODUCT INFORMATIONS | Air entrainment valve to allow breathing of room air when ventilator air pressure drops | Yes |
| PRODUCT INFORMATIONS | Universal Nebulizer port | No |
| PRODUCT INFORMATIONS | Expiratory port | No |
| PRODUCT INFORMATIONS | Bronchoscopy port | No |
| PRODUCT INFORMATIONS | Luer lock port caps | Yes |
| PRODUCT INFORMATIONS | Swivel assembly for easy connectivity | Yes |
| PACKAGING | Type of Packing | Individually packed |
| CERTIFICATION & REPORTS | Compliance to Medical Device Rules (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) | 12, 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 |
| ADVANCE SAMPLE | Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding | Yes, No |
Frequently Asked Questions
Key insights about KARNATAKA tender market
How to bid on BiPAP mask tender in Gulbarga Karnataka 2026
Bidders must meet MDR 2017 compliance, possess ISO 9001 certification (bidder or OEM), provide advance sample before technical evaluation, and submit batch test reports along with drug license under the Drugs and Cosmetic Act. Delivery terms require 15 days after PO; quantity may vary ±25%. Ensure documents are uploaded and service support details provided.
What documents are required for ESIC BiPAP mask procurement in Karnataka
Submit GST registration, PAN card, experience certificates for similar medical devices, last 3 years financial statements, MDR-compliant test reports for each batch, ISO 9001 certificate, drug license, manufacturing unit certificate, OEM authorization if applicable, and advance sample prior to technical evaluation.
What are the technical specifications for the BiPAP mask in this tender
Required features include auto-adjustable mask, non-toxic medical-grade material, single-layer infection-control cushion, soft transparent frame, flexible winged forehead frame, headgear clips, squeeze-type elbow, built-in vent port, air entrainment valve, nebulizer and expiratory ports, bronchoscopy port, Luer lock caps, and swivel assembly with MDR 2017 compliance.
What is the delivery timeline for purchase orders in this ESIC tender
Delivery must occur within 15 days of PO issuance; option clause allows up to ±25% quantity adjustment during contract, with delivery time recalculated proportionally; late delivery may incur penalties per GeM policy.
What certifications and standards are mandatory for bidders
Mandatory MDR 2017 compliance for the medical device, ISO 9001 certification for bidder or OEM, drug license under Drugs and Cosmetic Act, and batch test reports for every supplied lot. Manufacturing unit certification is also required.
How is quantity variation handled in this BiPAP mask contract
The purchaser may increase or decrease quantity up to 25% at bid/contract time; during currency of contract, ordered quantity may vary by ±25% at contracted rates; delivery schedule adjusts using the specified formula.
What is required for advance sample submission in this tender
Advance sample submission is mandatory before technical evaluation; samples will be evaluated by the Technical Evaluation Committee for healthcare utility; non-submission leads to potential rejection of the bid.
Where to find service support requirements for this ESIC procurement
Bidder or OEM must provide a dedicated or toll-free service support line; ensure contact details are included in the bid and are active for post-sale support and warranty handling.