Dental X - Ray Machine (V2)
All India Institute Of Medical Sciences (aiims)
Posted:
30 May 2025
Closed:
9 June 2025
GEM
GEM
HFWS Shivamogga Dental X-Ray Machine Tender Shimoga Karnataka Equipment with MDR 2017 Compliance 2026
Bid Publish Date
11-Jul-2026, 4:33 pm
Bid End Date
21-Jul-2026, 5:00 pm
Location
Progress
Issue11-Jul-2026, 4:33 pm
AwardPending
Quantity
1
Bid Type
Single Packet Bid
Categories
1
Tender Overview
Organization: HFWS Shivamogga (Health and Family Welfare Department, Karnataka) seeks a Dental X-Ray Machine (V2) for the Soraba taluk facility in Shimoga district, Karnataka. The procurement includes installation, training, and delivery to Soraba Taluk General Hospital, Soraba-577429. Key differentiators are mandatory MDR 2017 compliance, AERB Type Approved Model status, and IS 7620 conformity with full test reports. The vendor must ensure OEM direct service presence in India and uninterrupted spare parts for 10 years. The scope emphasizes high-precision imaging, lead shielding, and patient safety accessories such as thyroid shields and lead aprons.
Technical Specifications & Requirements
- Product Name: Dental X-Ray Machine (V2)
- Key specs: Tube voltage (KV), Tube current (mA), Focal spot (mm), Inherent vs total filtration (mm Al), Minimum exposure time, Wall-mountable with stable base and locking wheels, DC power supply, RVG/X-Ray film compatibility, optional comprehensive warranty, and an angular head positioning system.
- Certifications/Standards: MDR 2017 compliance, valid drug license under Drugs and Cosmetic Act 1940, AERB Type Approved Model, IS 7620 Part 1/2/3 conformity, electrical safety standards, and required test reports. OEM must provide English manuals, installation, and operator training. OEM presence/authorized service center in India is required with toll-free technical support.
- Delivery/Installation: Installation and demonstration post-supply, training before acceptance, and pre-dispatch inspection by Buyer or nominated agency.
- Warranty/Support: Optional comprehensive warranty; spare parts availability for 10 years; post-sale maintenance via OEM or authorized agency.
Terms & Eligibility
- Option Clause: Purchaser may adjust quantity by ±25% during or after award, with pro-rated delivery timing.
- Delivery Location: Administrative Medical Officer, Soraba Taluk Hospital, Soraba, Shimoga District, 577429.
- Bidder Requirements: No liquidation or bankruptcy; products should have ≥5 years residual market life; OEM must have India-based direct presence and post-sales network; pre-dispatch inspection at Seller premises with buyer’s costs if applicable.
- Documentation: Bid must include MDR compliance certificates, IS 7620 conformity, drug license, and test reports; user manuals in English; installation/demo proof; and OEM authorization.
Key Specifications
-
- Product Name: Dental X-Ray Machine (V2)
-
- Standards: MDR 2017, IS 7620 Parts 1-3, Electrical Safety Standards
-
- Certification: AERB Type Approved Model, Drug License under Drugs and Cosmetic Act 1940
-
- Power: DC current supply, high voltage generator with high efficiency
-
- Imaging: RVG/X-Ray film compatible, exclusive angular head positioning, high resolution for sharp radiographs
-
- Physical: Stable base with locking wheels, wall-mountable, patient stool, soft positioning arms, lead apron set, thyroid shield
-
- Protection: Internally lead-coated head tube and cone for scatter radiation reduction
-
- Service: OEM direct presence in India, toll-free technical support, 10-year spare parts availability
-
- Documentation: All certifications, licenses, and test reports to be submitted with bid and at delivery
Terms & Conditions
-
EMD not explicitly stated; expect standard bidder security and compliance per state procurement rules
-
Quantity variances up to 25% permitted with adjusted delivery timeline
-
Pre-dispatch inspection arranged by buyer or authorized agency with applicable fees
-
Delivery and installation to Soraba Taluk General Hospital, Shimoga district
-
OEM/Authorized seller must provide English manuals and 10-year spare parts availability
Important Clauses
Payment Terms
Not specified in data; align with standard government procurement terms and MDR compliance invoicing after delivery and acceptance
Delivery Schedule
Delivery to commence after order and must include installation and training; option to extend delivery period with 30+ days minimum when quantity is increased
Penalties/Liquidated Damages
Not specified; bidders should expect LD provisions as per state bid terms and delivery deviations
Bidder Eligibility
-
No liquidation, court receivership, or similar proceedings
-
Minimum 5 years residual market life for offered product
-
Direct Indian OEM presence or approved service center with toll-free technical support
-
Ability to provide pre-dispatch inspection and post-sale spare parts for 10 years
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
No
Item Category
Dental X - Ray Machine (V2) (Q2)
Payment Timelines
Payments shall be made to the Seller within 45 days of issue of consignee receipt-cum-acceptance certificate (CRAC) and on-line submission of bills (This is in supersession of 10 days time as provided in clause 12 of GeM GTC)
Delivery Details
Max Delivery Days
15
Delivery Locations
1
Delivery Cities
Shivamogga
Delivery Pincodes
577201
Delivery Locations
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| Nataraj K S | 577201,NEAR HARSHA COMPLEX B H ROAD SHIVAMOGGA | Shivamogga | Karnataka | 577201 | 1 | 15 | - |
Authority Records
HEALTH AND FAMILY WELFARE DEPARTMENT
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Bid Preparation
GeM Registration
Document Filing
Free consultation · 24h response
Documents 3
GeM-Bidding-9594211.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 | Product Name | Dental X-Ray Machine |
| PRODUCT INFORMATION | Tube voltage (KV) | 65 KV, 70 KV |
| PRODUCT INFORMATION | Tube current (mA) | 2 to 8 mA |
| PRODUCT INFORMATION | Focal spot (mm) | 0.4 to 0.8 mm |
| PRODUCT INFORMATION | Should have Total filtration and Inherent Filtration | Yes |
| PRODUCT INFORMATION | Total filtration in mm Al | ≥ 2 mm Al |
| PRODUCT INFORMATION | Inherent filtration | ≥ 0.5 mm Al |
| PRODUCT INFORMATION | Minimum Exposure Time | 0.02 to 2 seconds |
| PRODUCT INFORMATION | Power supply | 220-240 V, 50 Hz single phase |
| PRODUCT INFORMATION | Based on DC Current | Yes |
| PRODUCT INFORMATION | RVG / X Ray Film compatible | Yes |
| PRODUCT INFORMATION | Machine should have a stable base with sturdy locking wheel mechanism | Yes, No |
| PRODUCT INFORMATION | Wall Mountable | No |
| PRODUCT INFORMATION | Digital control equipped with an easy ready display indicating with precision | Yes |
| PRODUCT INFORMATION | Stool for the patient provided | Yes |
| PRODUCT INFORMATION | Soft positioning arms for accurate tube positions | Yes |
| PRODUCT INFORMATION | Light and flexible movements | Yes |
| PRODUCT INFORMATION | Internally lead coated head tube and cone to avoid scattered radiations | Yes |
| PRODUCT INFORMATION | Exclusive angular indicating system for head positioning in various radiography techniques | Yes |
| PRODUCT INFORMATION | High efficiency and greater sharpness of the radiography | Yes |
| Additional Parameters | Should have high voltage generator with high efficiency in the emission of the X rays | Yes |
| Additional Parameters | Should have free swivel head, which allows easy positioning of head | Yes |
| Additional Parameters | Number of lead aprons provided | 2 (0.5 mm lead equivalent) |
| Additional Parameters | To be supplied with Thyroid shield | Yes |
| CERTIFICATION AND REPORTS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| CERTIFICATION AND 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 AND REPORTS | AERB Type Approved Model | Yes |
| CERTIFICATION AND REPORTS | Conformity to Indian Standard IS 7620- Part 1, Part 2, Part 3 | Yes |
| CERTIFICATION AND REPORTS | Manufacturing unit certification | ISO:13485 (Latest) |
| CERTIFICATION AND REPORTS | Availability of Test Report for product as per Medical Device Rules (MDR) 2017 as amended till date | Yes |
| CERTIFICATION AND REPORTS | Electrical Safety Standards | IEC/EN 60601-1 or equivalent BIS Standard |
| CERTIFICATION AND REPORTS | 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 |
| WARRANTY | Warranty (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) | 5 Or higher |
| MISCELLANEOUS REQUIREMENTS | User/Technical/Maintenance manuals to be supplied in English in hard and soft copy | Yes |
| MISCELLANEOUS REQUIREMENTS | Installation and Demonstration of equipment and training to be provided after completing supplies before acceptance | Yes |
| MISCELLANEOUS REQUIREMENTS | Principal Manufacturer must have direct Presence/approved service center In India | Yes |
| MISCELLANEOUS REQUIREMENTS | Availability of toll free facility for technical support maintened by OEM or authorized agencies | Yes |
| MISCELLANEOUS REQUIREMENTS | OEM/Reseller shall ensure uninterrupted availability of all spares for 10 years | Yes |
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Historical Data
Required Documents
1
GST registration certificate
2
PAN card
3
Experience certificates of similar dental imaging equipment supply
4
Financial statements or solvency proof
5
EMD/Security deposit documentation (as applicable)
6
Technical compliance certificates (MDR 2017, Drug license, AERB Type Approval)
7
Test reports per MDR 2017 and IS 7620
8
OEM authorisation / authorised service center proof in India
9
User manuals (English) – hard and soft copies
10
Installation, commissioning, and training plan
Frequently Asked Questions
Key insights about KARNATAKA tender market
How to bid for the dental X-ray machine tender in Shimoga Karnataka
Bidders must submit MDR 2017 compliance certificates, IS 7620 conformity, AERB Type Approval, drug license, and test reports with the bid. Provide OEM authorization, English manuals, installation/demo plan, and proof of India-based service presence. Include installation and training commitments and 10-year spare parts availability.
What documents are required for the Karnataka dental X-ray bid
Required documents include GST registration, PAN, financial statements, experience certificates for similar imaging equipment, MDR compliance certificates, IS 7620 conformity, AERB Type Approval, drug license, OEM authorization, and pre-dispatch inspection readiness. Provide English manuals and installation/training plan.
What standards govern the dental X-ray machine procurement in Shimoga
The tender requires MDR 2017 compliance, IS 7620 Parts 1-3 conformity, Electrical Safety Standards, and an AERB Type Approved Model. Vendors must supply test reports and drug license to meet regulatory and safety requirements for medical imaging devices.
What are the delivery terms for the Shimoga X-ray equipment
Delivery is to Soraba Taluk Hospital, Soraba-577429. Installation and training occur post-delivery. The buyer may extend delivery for up to 30+ days if quantity increases; pre-dispatch inspection may be required with costs borne by the buyer.
What is required for post-sale support of the X-ray machine
OEM must have direct presence in India or an approved service center, with toll-free technical support. Spare parts must be available for 10 years, and English user manuals must be supplied in both hard and soft copies.
What constitutes essential certifications for the bidder
Bidder must provide MDR 2017 compliance, IS 7620 Parts 1-3 conformity, AERB Type Approval, and valid drug license. Also required are manufacturing unit certification and test reports as per Medical Device Rules.
How will quantity variations affect delivery timelines
The purchaser may increase/decrease quantity by up to 25% at contract, with adjusted delivery timelines calculated as (additional quantity/original quantity) × original delivery period, minimum 30 days; delivery commences from the last date of the original order.
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Documents 3
GeM-Bidding-9594211.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS