SUPPLY OF MEDICAL EQUIPMENT & INSTRUMENTS TO ENT DEPARTMENT, DISTRICT HOSPITAL, BALLARI UNDER DMF FUND

MANUFACTURING LICENSE: A.For Manufacturer a). Manufacturing License duly renewed up to date along with list of products permitted to manufacture for non-medical devices and CDSCO MD 5 Certificate or applicable CDSCO Certificate for Medical devices is to be uploaded in original, if Tenderer is a Manufacturer.b).Valid SSI/MSME or equivalent Certificate, issued by Director of Industries Commerce, Government of Karnataka/MSME or equivalent Certificate with list of products permitted to manufacture is to be uploaded in original and CDSCO-5 Certificate or applicable Certificate should be uploaded in original for Medical devices if Tenderer is a Manufacturer claimed under this Clause, otherwise they will not be treated as SSI/MSME or equivalent unit.B. For Authorized Dealers/Authorized Importers:- a).If Tenderer is an Authorized Agent/Distributor: Notarized Manufacturing License, duly renewed up to date along with list of products permitted to manufacture for Indian Principal Manufacturer for Non-Medical devices and CDSCO MD 5 or applicable CDSCO Certificate for Medical devices should be uploaded, b).If Tenderer is an Importer Authorized Agent/Distributor, should submit CDSCO MD-15 or applicable CDSCO Certificate.

A.6-MANUFACTURERS AUTHORIZATION CERTIFICATE:The Authorization Certificate from original Manufacturer (OEM) is to be uploaded in original from reputed Manufacturers, if Tenderer is an Principle Authorized Agent or Distributor and Licensed Authorized Importer as per Section:XIV. Note:The Sub-Agents or Sub-Distributor is not eligible.

A.9-LIST OF EQUIPMENTS QUOTED UNDER THIS TENDER:List of Equipments/Instruments along with Manufacturer/s Name, Country of origin and Model quoted by the tenderer should be clearly furnished separately as per Section-XIX, is to be uploaded in original.

LIST OF ITEMS SUPPLIES ALONG WITH USERS CERTIFICATE A.For Manufacturer::The Tenderer, if a Manufacturer who must have manufactured, tested and supplied the Equipment (s)/Instruments similar to the type specified in the Schedule of Requirements and Brand model quoted under this Tender up to at least 80 percent to the quantity in any one of the last 3 years (2022-23, 2023-24 and 2024-25). If quantity of Tender is one, then should have supplied minimum 01 Quantity. B).For Authorized Agent/Distributor: The tenderer, is an authorized Agent/Distributor, has supplied, installed and commissioned satisfactorily at least 80 percent and MSME/SSI Unit is 40 percent of the quantity similar to the type specified in the Schedule of Requirements and Brand model quoted under this Tender in any one of the last 03 years (2022-23, 2023-24 and 2024-25). If quantity of Tender is one, then should have supplied minimum 01 Quantity as per the Section-XIII and Users certificates as per Section-XV must be uploaded in original, otherwise Supply Orders will not be considered as performance. Note:Dont submit manufacturers other Agents/Distributors supply Order and User Certificates and they will not be considered.

STANDARDS OF QUALITY CONTROL CERTIFICATES:-(A).For Indian Manufacturer:-CDSCO Form-5 or applicable CDSCO Certificate along with ISO 13485 Certificate issued by NABC notification body should be uploaded in Original (B).For Importer Authorized Agent/Distributor:-CDSCO Form-15 or applicable CDSCO Certificate along with European CE or US FDA

A.4-ANNUAL TURN-OVER STATEMENT:Annual Turnover statement for proceeding three financial years 2022-23, 2023-24 and 2024-25 i.e for 31-03-2023, 31-03-2024 and 31-03-2025 of the Tenderer as per Sectin:XVII Certified by Commercial Tax Officer or Charted Accountant is to be uploaded in original. The Tenderer should have minimum Average Annual Turnover for last three years for qualify in the Tender as follows: 1.Endoscopic 4K Imaging System For ENT-01 No-Rs.6973000.00-For Manufacturer or Authorized Distributors and Agents 100 Percent to the estimated Tender Value and Rs.3486500.00 For MSME or SSI Units 50 Percent to the estimated Tender Value, 2. Micro Laryngoscopy (MLS) Instruments Set-01 Set- Rs.1000968.00 For Manufacturer or Authorized Distributors and Agents -100 Percent to the estimated Tender Value and Rs. 500484.00 For MSME and SSI Units 50 Percent to the estimated Tender Value

A.1-GST REGISTRATION CERTIFICATE: GST Registration Certificate of the Tenderer in original is to be uploaded.

A.2-PAN CARD: PAN Card of the Firm or Tenderer is to be uploaded in original.

A.3-GST RETURNS: GST Returns for the last six months from 01-2025 to 06-2025 to be uploaded in original.

A.7-REGISTRATION CERTIFICATES UNDER COMPANIES ACT:Registration Certificates of Companies document under Companies Act to be up loaded in original, If bidder is having company-If applicable only.

A.8:a-TENDER OFFER FORM-PART I: Tender Offer Form with an undertaking to abide by the terms and conditions of the tender in the format as per Section:IX Part I, of the Tenderer is to be uploaded in original.

A.8:b-DECLARATION FROM PART II:Declaration from the Tenderer in the format as per Section:IX Part II of the Tenderer is to be uploaded in original.

A.12-TECHNICAL SPECIFICATIONS INFORMATION LITERATURE & BROCHURE OF THE EQUIPMENTS:The Technical specifications information complete Literature and Brochure of the Equipments quoted by the Tenderer should be uploaded in original.

A.13-COMPLIANCE FOR THE TENDER SPECIFICATIONS AND CLARIFICATIONS FOR DEVIATIONS: Compliance for the Tender specifications and clarifications for deviations of the Equipments quoted by the Tenderer should be uploaded in original.

A.14-PROOF OF SERVICE CENTRES IN KARNATAKA & TECHNICAL STAFF AVAILABLE:Service Centres in Karnataka with Address and Contact No and Technical Staff available for the Equipments as per the Section:XVIII and Proof of Service Centres in Karnataka and Technical Staff available and Under taking from manufacturer for providing service for the equipment during warranty and CMC quoted under this Tender should be uploaded in original and service shall be provided within 72 hrs from the receipt of the complaint.

A.15-FORMAT FOR LIST OF DOCUMENTS AND INFORMATION SUBMITTED UNDER THIS TENDER: SECTION:XX:Check List.