GEM

Karnataka Health & Family Welfare Department Knee Braces and Splints Tender 2025 - MDR Medical Device Compliance ISO 9001 NABCB

Posted

27 Oct 2025, 02:38 pm

Deadline

06 Nov 2025, 04:00 pm

Location

KOLAR , KARNATAKA

Progress

Issue27 Oct 2025, 02:38 pm
AwardPending
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Quantity

400

Bid Type

Two Packet Bid

Key Highlights

  • • Local office requirement in Bangalore/Karnataka
  • • ISO 9001 certification from NABCB certified body
  • • MDR 2017 compliance with valid Medical Device license/registration
  • • Batch-wise test reports for each supplied product
  • • Manufacturing unit certification and OEM authorizations (if applicable)
  • • Delivery quantity flexibility up to 25% during contract
  • • GST handling: reimbursement as per actuals or applicable rates
  • • End User Certificate provision if required by buyer

Categories 3

BRACES FIRST AID BOX ORTHODONTIC AND PROSTHODONTIC EQUIPMENT

Tender Overview

The Karnataka Health and Family Welfare Department invites bids for knee braces and splints under the general product category for medical use, including variants with adjustable functionality, different sizes, and stretchability options. The procurement scope emphasizes MDR 2017 compliance, valid Medical Device licenses, and batch-wise testing reports. A local Bengaluru/Karnataka office is required, along with NABCB ISO 9001 certification. The tender cites a flexible quantity clause up to 25% increase/decrease and a delivery schedule linked to the original delivery period, with adjustments for extended periods. Detailed supplier documentation will be evaluated against regulatory licenses and shelf-life criteria.

Technical Specifications & Requirements

  • Product category: Knee braces and splints with adjustable openings, stretchability options, and various sizes
  • Compliance: MDR 2017 (amendments till date) and valid Medical Device license under Drugs and Cosmetics Act
  • Certifications: Manufacturing unit certification; Test reports for each batch as per MDR; Certificates and licenses to be furnished at bid submission or along with supplies
  • Shelf life: Minimum shelf life at delivery; months to be specified; delivery to consignee with adequate remaining shelf life
  • Documentation: Submission of certifications, licenses, and test reports with bid; OEM authorizations if applicable; End User Certificate if required
  • Manufacturing/quality: ISO 9001 certification (NABCB certified body) and local presence in Bangalore/Karnataka
  • Additional: Local office requirement; GST considerations as applicable; option clause allowing up to 25% quantity adjustment

Terms, Conditions & Eligibility

  • EMD details: Not disclosed in available data; bidders must verify at bid submission
  • Local presence: Required local office in Bengaluru/Karnataka
  • Certifications: ISO 9001 (NABCB); MDR compliance; Medical Device license/registration
  • Documentation: Upload all required certificates, licenses, test reports; End User Certificate as applicable
  • Delivery: Option to adjust delivery quantity by up to 25%; extended delivery calculations as per contract terms
  • GST: Bidder bears GST; reimbursement as per actuals or applicable rates
  • Penalties: Not explicitly stated; ensure compliance with buyer terms

Key Specifications

  • Knee braces and splints with adjustable functionality and multiple sizes

  • MDR 2017 compliance; valid Medical Device license under Drugs and Cosmetics Act

  • Batch-wise test reports for each supplied item

  • IS/ISO standards: ISO 9001 certification from NABCB

  • Shelf life: minimum months specified at delivery; adequate remaining shelf life

Terms & Conditions

  • Option clause allows ±25% quantity variation during contract

  • Local Bangalore/Karnataka office required for eligibility

  • MDR compliance and Medical Device licenses mandatory

  • ISO 9001 (NABCB) certification required for bidders

  • Submission of required test reports and licenses at bid or delivery

  • GST responsibility with applicable reimbursement terms

Important Clauses

Payment Terms

Not specified in available data; bidder should verify during bid submission

Delivery Schedule

Delivery period linked to original order; option-based quantity adjustments allowed up to 25%

Penalties/Liquidated Damages

Not explicitly detailed; ensure compliance with buyer terms and contract specifics

Bidder Eligibility

  • Must have a local office in Bengaluru/Karnataka

  • Must hold ISO 9001 certification from a NABCB-accredited body

  • Must demonstrate MDR 2017 compliance with valid Medical Device license/registration

  • Must provide batch-wise test reports and related certifications

Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL Product Description Knee Braces and Splints
PRODUCT INFORMATION Product Use Knee and Leg Bracing for applying skin traction, Knee Joint Support for immobilization, Knee Joint support with provision for controlled Range of Motion of Knee Flexion and Extension.
PRODUCT INFORMATION Product style Knee Cap
PRODUCT INFORMATION Features of braces and splints Flexible
PRODUCT INFORMATION Patient Type Adult, Paediatric, Infant
PRODUCT INFORMATION Adjustable Functionality Yes
PRODUCT INFORMATION Type of opening Elastic with closed patella (Knee Cap), Sleeve Type
PRODUCT INFORMATION Stretchability Yes
PRODUCT INFORMATION Type of Stretchability 4 way
PRODUCT INFORMATION Material of components Knitted elastic tape
PRODUCT INFORMATION Size Medium, Large
Certifications & Reports Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
Certifications & Reports Availability of valid Medical Device license/Registration 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 from the date of manufacture (in months) 12, 18, 24, 30, 36, 48 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

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates for medical device supplies

4

Financial statements / stability documents

5

EMD/Security deposit documents (if applicable)

6

Technical bid documents demonstrating MDR compliance

7

Medical Device license/registration certificates

8

Manufacturing unit certification

9

Batch test reports per MDR for supplied products

10

OEM authorization letters (if bidding as a distributor)

11

End User Certificate (if requested)

Frequently Asked Questions

How to bid for knee braces tender in Karnataka 2025 with MDR compliance

Bidders must meet local office eligibility in Bengaluru, provide MDR 2017 compliant devices, submit valid Medical Device licenses, batch test reports, and ISO 9001 certification from a NABCB-approved body. Include End User Certificate if required and adhere to the 25% quantity option clause during contract execution.

What documents are required for knee braces tender in Bengaluru

Submit GST certificate, PAN, experience certificates in medical devices, financial statements, EMD documents if specified, MDR compliance certificates, Medical Device license, batch test reports, ISO 9001 certificate, and OEM authorizations where applicable. Ensure all documents accompany bid submission.

What are the technical specifications for knee splints in this bid

Product range includes knee braces/splints with adjustable openings, various sizes, stretchability options, and materials details per MDR guidelines. Compliance with MDR 2017, valid licenses, and batch-wise test reports are required; shelf life details must meet minimum delivery requirements.

When is the delivery window and extension policy for this tender

Delivery terms allow quantity variation up to 25% and extended delivery time calculated as (increased quantity ÷ original quantity) × original delivery period, with a minimum of 30 days; actual delivery schedule to be confirmed in contract.

What are the payment terms for knee brace procurement in Karnataka

Payment terms are not explicitly disclosed; bidders should anticipate standard procurement terms and confirm with the buyer. GST reimbursement will be as per actuals or applicable rates, limited by quoted GST percentage.

What certifications and licenses are mandatory for bidders

Mandatory MDR 2017 compliance, valid Medical Device license/registration under Drugs and Cosmetics Act, Manufacturing unit certification, and ISO 9001 certification from a NABCB-certified body; batch test reports must be available for all supplied items.

What about End User Certificate requirements for this bid

End User Certificate may be requested by the buyer; bidders must prepare and provide the certificate in the buyer’s standard format if invoked by procurement terms.

Where can I verify local presence and NABCB ISO 9001 requirements

Confirm local Bengaluru/Karnataka office presence and validate ISO 9001 accreditation with NABCB-approved bodies. Ensure your certificate scope covers medical devices and is currently valid at the time of bid submission.

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