Health Department Haryana Steam Sterilization Chemical Indicator Tender Rohtak 2026 MDR 2017 Compliance
Progress
Key Highlights
- • Regulatory focus: MDR 2017 compliance for steam sterilization indicators
- • Medical Device license validity under Drugs and Cosmetic Act 1940
- • Minimum shelf life requirement at time of delivery
- • Option clause enabling ±25% quantity variation
- • OEM/Authorized Seller must have India-based registered office for after-sales service
- • No BOQ items listed; emphasis on regulatory conformity and product certifications
Tender Overview
The Health Department Haryana invites bids for a Chemical Indicator for Steam Sterilization Process in Rohtak, Haryana (124001). Key requirements include MDR 2017 compliance, valid Medical Device license under the Drugs and Cosmetic Act, and a minimum shelf life for delivery. The contract allows a potential quantity variation of up to 25%, with extension provisions based on the original delivery period. Although no BOQ items are listed, the tender emphasizes regulatory conformity and post-deployment support for steam sterilization indicators.
Technical Specifications & Requirements
- Category: GENERAL product description and PRODUCT INFORMATION for indicator signal, class/type, and presentation
- Certifications: Compliance to MDR 2017; valid Medical Device license under Drugs and Cosmetic Act 1940 and Rules thereunder
- Shelf Life: Minimum shelf life required at the time of delivery to the consignee
- Delivery & OEM: If imported, OEM/Authorized Seller must have a registered office in India for after-sales service; evidence must be submitted
- BOQ: No items listed; bid should address product conformity and regulatory readiness rather than quantity-based specifications
- Placement: Deliverables to be aligned with regulatory standards for medical devices and infection control
- The tender stresses regulatory compliance and after-sales support as critical selection criteria
Terms, Conditions & Eligibility
- Option Clause: Quantity may increase/decrease by up to 25% at contract placement or during currency at contracted rates
- Delivery Extension: If exercised, extension formula is (increased quantity ÷ original quantity) × original delivery period, minimum 30 days; may extend to original delivery period
- OEM Requirement: Imported products require a registered Indian office of the OEM for after-sales service
- EMD & Documents: Specific EMD amount and document lists are not disclosed in the provided data; submit regulatory and product compliance evidence as applicable
- Compliance: Bidder must demonstrate MDR 2017 compliance and provide license validity details; ensure product presentation and indicator class/type meet stated criteria
Key Specifications
-
Product category: Chemical Indicator for Steam Sterilization
-
Indicator signal: specified in product information
-
Class/Type: indicated in product information
-
Presentation: suggested form for indicator presentation
-
Certifications: MDR 2017 compliance; Medical Device license under Drugs and Cosmetic Act
-
Shelf life: minimum required at delivery
Terms & Conditions
-
Quantity variation up to 25% during contract period
-
India-based OEM after-sales support for imported products
-
Regulatory certifications MDR 2017 and Medical Device license required
Important Clauses
Delivery & Quantity Variation
Up to 25% increase/decrease in bid quantity allowed; extended delivery period computed with minimum 30 days.
OEM & After-Sales
Imported items require OEM registered in India; evidence of after-sales service must be submitted.
Regulatory Compliance
Product must comply with MDR 2017 and hold valid Medical Device license under Drugs and Cosmetic Act.
Bidder Eligibility
-
Demonstrated MDR 2017 compliance for medical device indicators
-
Valid Medical Device license under Drugs and Cosmetic Act
-
Evidence of Indian-based OEM/authorized service capability for imported items
Tender Data
Bid Details
Quantity
70
Bid Type
Two Packet Bid
Bid Validity
180 (Days)
Bid Type
Service
Evaluation
Total value wise evaluation
Inspection Required
No
RA Qualification Rule
H1-Highest Priced Bid Elimination
Tech Clarification Time
2 Days
Preference & Exemptions
EMD Required
No
MII Purchase Preference
No
MSE Purchase Preference
No
MSE Exemption/Relaxation
No
Startup Exemption/Relaxation
No
Bid Splitting Applied
No
Requirements
Past Performance
40 %
Experience Required
1 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
Chemical Indicator for Steam Sterilization Process (Q2)
Delivery Details
Max Delivery Days
30
Delivery Locations
1
Delivery Cities
Rohtak
Delivery Pincodes
124001
Delivery Locations
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| Divya Kalra | 124001,Postgraduate Institute of dental Sciences Rohtak 124001 | Rohtak | Haryana | 124001 | 70 | 30 | - |
Authority Records
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Documents 3
GeM-Bidding-9732453.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
Categories
5
Required Documents
GST registration certificate
PAN card
Medical Device license details and validity
Evidence of MDR 2017 compliance
OEM authorization (for imported items) and Indian registered office proof
Product technical specifications and conformity certificates
Delivery lead-time proposal and after-sales support plan
Technical Specifications
1 Item
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| GENERAL | Product Description | Chemical Indicator for Steam Sterilization Process |
| PRODUCT INFORMATION | Indicator Signal | Color Change |
| PRODUCT INFORMATION | Class/Type of Chemical Indicator | Class/Type 1 |
| PRODUCT INFORMATION | Presentation of Indicator | Tape |
| CERTIFICATIONS | Compliance to Medical Device Rule (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Availability of valid Medical Device 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 |
| SHELF LIFE | Minimum shelf life of the product at the time of delivery to the consignee | 3/4 th of Total Shelf Life |
Frequently Asked Questions
Key insights about HARYANA tender market
How to bid for the chemical indicator tender in Rohtak Haryana 2026
To bid, ensure MDR 2017 compliance and a valid Medical Device license under the Drugs and Cosmetic Act. Submit OEM authorization if imported, proof of India-based service, and regulatory certificates along with product specifications. Provide delivery timelines and shelf-life details; adhere to 25% quantity variation terms.
What documents are required for medical device indicator tender in Rohtak
Prepare GST and PAN, MDR compliance certificates, Medical Device license details, OEM authorization (for imports), proof of India-based service, product specifications, and delivery schedule. Include shelf-life commitment and compliance with applicable medical device regulations for the Rohtak tender.
What standards apply to chemical indicators for steam sterilization in Haryana
Bidders must show MDR 2017 compliance and a valid Medical Device license under the Drugs and Cosmetic Act. Present the indicator’s class/type and presentation details per product information, ensuring sterility-related performance and regulatory alignment for Haryana procurement.
What is the delivery time and quantity variation allowed in this tender
Delivery time is subject to contract terms with an option to increase/decrease quantity by up to 25%. If exercised, the extension is calculated as (increased quantity ÷ original quantity) × original delivery period, with a minimum of 30 days and possible extension up to the original delivery period.
What is required for imported chemical indicators in this Rohtak tender
Importers must provide OEM authorization and a registered Indian office for after-sales service. Submit documentation proving OEM presence in India, along with MDR 2017 conformity and Medical Device license for the product, to participate in the Haryana tender.
What is the shelf life requirement for the steam sterilization indicators
The tender specifies a minimum shelf life at the time of delivery to the consignee. Suppliers should commit a specific shelf-life duration per lot and provide lot-specific certificates validating expiry dates and storage stability.
How to demonstrate MDR 2017 compliance for this Haryana bid
Provide a current MDR 2017 compliance certificate, along with the product’s Medical Device license details and issuance authority. Include scope of device, license validity, and any notified body conformity assessment reports relevant to steam sterilization indicators.
What submission-ready documents are crucial for this Rohtak bid
Key documents include GST, PAN, MDR certificates, Medical Device license, OEM authorization (for imports), evidence of Indian service capability, product datasheet, and delivery plan. These ensure regulatory readiness and technical conformity for the Rohtak Health Department procurement.