Kandla Port Trust Digital Blood Pressure Monitor Tender Gujarat 2026 MDR 2017 Compliance
Kandla Port Trust
KACHCHH, GUJARAT
Posted:
3 January 2026
Closed:
15 January 2026
GEM
GEM
Gangadhar Meher University Digital Blood Pressure Monitor Tender Odisha 2026 MDR Act Compliance
Progress
Issue29-Jun-2026, 5:51 pm
AwardPending
Quantity
6
Bid Type
Two Packet Bid
Key Highlights
- • Regulatory compliance required: MDR 2017 and Drugs and Cosmetic Act 1940
- • Model approval certificate from Director Legal Metrology for each model
- • OEM authorization mandatory with bid submission
- • Quantity variation right up to 25% during procurement and contract execution
- • ATC requires quoting for all items; no partial bid allowed
- • Delivery schedule tied to quantity; extended timelines follow a defined formula
Categories
7
Tender Overview
Organization: Gangadhar Meher University; procurement of a Digital Blood Pressure Monitor with a focus on cuff compatibility and basic clinical usability. Location: SAMBALPUR, ODISHA; estimated scope not disclosed; award will consider adherence to regulatory standards and OEM authorization. Key differentiator is mandatory compliance with MDR 2017 and possession of model approval certificates. The ATC clause requires full quotation for all listed items and OEM authorization, signaling a tightly controlled supply chain and accountable QA. The absence of a BOQ suggests a flexible quantity cap, with a potential 25% quantity variation as per the option clause.
Technical Specifications & Requirements
- Product category: Digital Blood Pressure Monitor; Cuff type: Standard cuff with measurement capability
- Compliance: Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 (as amended)
- Certification: Model approval certificate for each model to be provided from Director Legal Metrology at bidding or on demand
- ATC/BOQ notes: Quote for all items; provide OEM authorization; quantity can vary up to 25% during contract; delivery timelines adjust accordingly
- Other: No BOQ items available; baseline product must meet basic medical device governance and be traceable to regulatory approvals
Terms, Conditions & Eligibility
- EMD/Payment terms: Not explicitly stated; bidders must comply with option clause and adjusted delivery timelines when quantities change
- Delivery: Delivery period scales with quantity; minimum extension rules apply; extended delivery starts from last delivery order date
- Eligibility: OEM authorization required; bid must cover all ATC items; regulatory compliance with MDR and Act is mandatory
- Documentation: Provide model approvals, OEM authorization, and regulatory certificates upon bid submission
- Warranty/Penalties: Not specified; ensure alignment with contract delivery and regulatory compliance
Key Specifications
-
Digital Blood Pressure Monitor with standard cuff
-
Compliance with Drugs and Cosmetic Act 1940 and MDR 2017
-
Model approval certificate from Director Legal Metrology
-
OEM authorization required at bid submission
-
No fixed BOQ items; quantity may vary up to 25%
Terms & Conditions
-
Option clause permits ±25% quantity variation
-
Mandatory OEM authorization with bid
-
Regulatory compliance with MDR 2017 and Drugs Act required
Important Clauses
Payment Terms
Not explicitly defined in the provided terms; bidders must align with contract delivery and option-based quantity changes
Delivery Schedule
Delivery period starts from last date of original delivery order; extended time calculated as (increase quantity / original quantity) × original delivery period, minimum 30 days
Penalties/Liquidated Damages
Not specified in data; bidders should seek clarity on LD provisions within contract
Bidder Eligibility
-
OEM authorization available at bid submission
-
Regulatory compliance with MDR 2017 and Drugs Act
-
Ability to supply Digital Blood Pressure Monitors with standard cuff
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Digital Blood Pressure Monitor (Q2)
Authority Records
HIGHER EDUCATION DEPARTMENT
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Documents 4
GeM-Bidding-9534398.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
Buyer uploaded ATC document
ATC
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 |
|---|---|---|
| Generic | Type of Digital Blood Pressure Monitor | Upper Arm Digital Blood Pressure Monitor |
| Cuff & Physical Properties | Type of Cuff | Automated Cuff |
| Certification | Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Certification | Agreed to provide Model approval certificate for each model from Director Legal Metrology at the time bidding or on demand by buyer | Yes |
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Required Documents
1
OEM authorization letters
2
Model approval certificates from Director Legal Metrology for each model
3
Regulatory compliance certificates proving MDR 2017 and Drugs and Cosmetic Act adherence
4
Bid submission for all ATC items
5
Any existing product registrations or approvals
6
Proof of eligibility to supply medical devices
Frequently Asked Questions
Key insights about ODISHA tender market
How to bid for the Digital Blood Pressure Monitor tender in Sambalpur Odisha
Bidders must submit OEM authorization and model approval certificates from Director Legal Metrology, ensuring MDR 2017 and Drugs and Cosmetic Act 1940 compliance. Include all items under ATC, and be prepared for quantity variation up to 25% during contract. Provide regulatory certificates with bid submission.
What documents are required for the MDR compliant BP monitor bid in Odisha
Submit OEM authorization, model approval certificates for each model, regulatory compliance proofs for MDR 2017 and Drugs Act, and documentation proving ability to meet ATC item requirements. Include any product registrations and manufacturer certifications as part of technical bid.
What are the delivery terms for quantity variation in this tender
Delivery period begins after the original delivery order; for increased quantity, time extended by (increased/original) × original period, with a minimum of 30 days. Purchaser may extend delivery up to the original period under the option clause.
What is required for OEM authorization in this BP monitor tender
Bidders must provide OEM authorization at bid submission or as demanded by the buyer, confirming the bidder is authorized to supply the specified BP monitors and related components, ensuring compatibility with MDR and regulatory standards.
Which regulatory standards must BP monitors meet for this Odisha tender
Monitors must comply with MDR 2017 and Drugs and Cosmetic Act 1940; model approvals must be obtained from Director Legal Metrology for each model, ensuring traceable compliance.
What are the key eligibility criteria for the Odisha BP monitor bid
Eligibility requires OEM authorization, MDR 2017 and Drugs Act compliance, ability to quote all ATC items, and readiness to handle 25% quantity variation with compliant delivery timelines.
When will the bidder need to provide model approval certificates
Model approval certificates must be supplied at bidding or on buyer demand, for each model, to verify regulatory compliance before contract award.
What happens if the BOQ items are not available in this tender
In the absence of a BOQ, bidders must still quote for all ATC items listed, ensuring OEM authorization and regulatory compliance, with capability to adapt to potential quantity changes.
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Documents 4
GeM-Bidding-9534398.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
Buyer uploaded ATC document
ATC
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS