Health & Family Welfare Department Jammu & Kashmir Dengue Malaria Rapid Test Kits Tender Baramulla 2026 MDR 2017 Compliant
N/a
BARAMULLA, JAMMU & KASHMIR
Posted:
20 February 2026
Closed:
10 March 2026
GEM
GEM
Employees State Insurance Corporation Rapid Test Kits Tender Mumbai Maharashtra 2026 IS0 9001 MDR 2017
Bid Publish Date
16-Apr-2026, 3:53 pm
Bid End Date
25-May-2026, 9:00 am
Location
Progress
Issue16-Apr-2026, 3:53 pm
Corrigendum05-May-2026
AwardPending
Quantity
264
Category
Point of Care Rapid Test Kits for Humans – Dengue, Malaria, Typhoid & Others
Bid Type
Two Packet Bid
Categories
2
Tender Overview
Organization: Employees State Insurance Corporation (ESIC) – Mumbai, Maharashtra. Primary procurement: Point of Care Rapid Test Kits for humans, covering Dengue, Malaria, Typhoid & others (Q2) and rapid tests for HIV/Syphilis/HBV/HCV (Q2). Scope includes supply of test kits with defined performance criteria and compliance requirements. Estimated value and EMD not disclosed; delivery location is ESIC Post Graduate Institute of Medical Sciences and Research, MIDC, Central Road, Chakala Industrial Area, Andheri East, Mumbai. Unique aspects include mandatory ISO 9001 certification for bidder or OEM, and adherence to Drugs and Cosmetic Act 1940 and MDR 2017 with updated amendments. Option clause allows ±25% quantity variation at contract award and during currency at contracted rates. This opportunity requires per-order billing and staggered delivery aligned to consignee details.
Technical Specifications & Requirements
- Product information: Type of Test Kit; Detection Type; Sample Type; Result Time; Sensitivity (%); Specificity (%); positive/negative controls provided with each kit; Number of Tests per Pack; Residual shelf life.
- Certifications: Compliance with Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license from competent authority; ISO 9001 certification for bidder or OEM.
- Other: Testing method and packaging specifics; repeated product information fields indicate dual entries in data; certificates require upload to bid; malicious code certificate is mandatory.
Terms, Conditions & Eligibility
- EMD/Payment terms: Not disclosed; billing on a per-order basis; staggered delivery schedule as per buyer’s on-site details.
- Delivery: Scope of supply is strictly goods only; delivery to ESIC facility in Mumbai; schedule must be aligned with on-signee details.
- Documentation: Upload all required certificates (ISO 9001, Medical Device license, MDR compliance, Drug Act compliance); ensure no missing documents to avoid rejection.
- Warranty/Quality: Certificates and quality assurances required; Malicious Code Certificate mandatory to avoid breach; supplier must maintain integrity of delivered kits.
Key Specifications
-
- Test kit type: Point of Care rapid tests for Dengue, Malaria, Typhoid & others; rapid HIV/Syphilis/HBV/HCV kits
-
- Detection & sample type: specify assay type and appropriate sample (blood/serum) as per kit
-
- Result time: (e.g., 10-20 minutes) per kit specification
-
- Sensitivity/Specificity: clearly stated percentages for each kit
-
- Controls: Positive and negative controls provided with each pack
-
- Pack size: Number of tests per pack; residual shelf life
-
- Certifications: MDR 2017 compliance; Drug Act compliance; Medical Device license
-
- Quality: ISO 9001 certification for bidder or OEM; malicious code certificate
-
- Delivery: Per-order billing; staggered delivery per buyer schedule to Mumbai location
Terms & Conditions
-
Option clause allows ±25% quantity variation at contract award and during execution
-
Per-order billing model; delivery staggered according to ESIC consignee details
-
Mandatory certifications: ISO 9001, MDR 2017 compliance, Medical Device license, Drug Act compliance
Important Clauses
Payment Terms
Billing to be on a per-order basis with delivery staggered per consignee details; no fixed advance mentioned
Delivery Schedule
Delivery to ESIC Post Graduate Institute, MIDC Chakala, Andheri East, Mumbai; timing aligned with original/delivered orders and option clause calculations
Penalties/Liquidated Damages
Not explicitly stated; implied through option clause and delivery delays may trigger LD as per contract terms
Bidder Eligibility
-
Must hold ISO 9001 certification (bidder or OEM)
-
Must comply with Drugs and Cosmetic Act 1940 and MDR 2017
-
Must have valid Medical Device license for the product
-
Must provide Malicious Code Certificate and related certifications
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Point of Care Rapid Test Kits for Humans – Dengue, Malaria, Typhoid & Others (Q2) , Rapid Test Kit for HIV / Syphilis / Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) (Q2)
Authority Records
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Documents 4
GeM-Bidding-9126788.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
CATALOG-Specification-2
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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Tender Results
Loading results...
Technical Specifications
2 Items
Item #1 Details
View Catalog| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Type of Test Kit | Malaria Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) Antigen Rapid Test Kit |
| PRODUCT INFORMATION | Detection Type | Qualitative |
| PRODUCT INFORMATION | Sample Type | Whole Blood |
| PRODUCT INFORMATION | Result Time | ≤ 30 minutes |
| PRODUCT INFORMATION | Sensitivity (%) | ≥ 98, ≥ 99 Or higher |
| PRODUCT INFORMATION | Specificity (%) | ≥ 98, ≥ 99 Or higher |
| PRODUCT INFORMATION | Positive and negative controls provided with each pack of kit | Yes, No |
| PACKAGING | Number of Tests per Pack | 50 Tests |
| SHELF LIFE | Residual shelf life of the product | Agree to provide residual shelf life of atleast 75% of total shelf life at the time of delivery to the consignee |
| CERTIFICATIONS | Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Availability of valid Medical Device license for the product issued from the competent authority | Yes |
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Historical Data
Required Documents
1
GST Registration Certificate
2
PAN Card
3
Experience Certificates (similar rapid test kit supply)
4
Financial Statements (last 3 years)
5
EMD/Security Deposit documentation (if required by ATC)
6
ISO 9001 Certification (bidder or OEM)
7
Medical Device License for the product
8
Drugs and Cosmetic Act/MDR compliance certificates
9
Malicious Code Certificate
10
Technical compliance documents and OEM authorizations (if applicable)
Corrigendum Updates
1 Update
#1
05-May-2026 Update
Extended Deadline
25-May-2026, 9:00 am
Opening Date
25-May-2026, 9:30 am
Frequently Asked Questions
Key insights about MAHARASHTRA tender market
How to bid on ESIC rapid test kit tender in Mumbai 2026
Bidders must submit ISO 9001 certification (bidder or OEM), Medical Device license, MDR 2017 compliance, and Drugs and Cosmetic Act certificates. Provide Malicious Code Certificate, GST, PAN, experience in similar supply, financial statements, and per‑order billing capability; ensure per‑order delivery and staggered schedule per consignee details.
What documents are required for ESIC rapid test kit bid Mumbai
Required documents include GST registration, PAN, experience certificates for similar kits, financial statements, EMD documentation if applicable, ISO 9001 certificate, Medical Device license, MDR compliance, Drugs and Cosmetic Act certificates, Malicious Code Certificate, and OEM authorizations if needed; upload all to avoid rejection.
What are the technical specifications for rapid test kits ESIC Mumbai
Kits must specify test type, detection type, sample type, result time, sensitivity and specificity percentages, and provide positive/negative controls with each pack; packing details include number of tests per pack and residual shelf life; compliance with MDR 2017 and Drug Act is mandatory.
When is delivery expected for ESIC rapid test kit supply
Delivery is on a per‑order basis with staggered scheduling aligned to ESIC consignee details; quantity variation up to 25% may be exercised during contract; delivery timeline depends on last date of original order and extended periods as per option clause.
What is the required certification for test kits in this ESIC tender
Bidders must have ISO 9001 certification (for bidder or OEM), and the product must comply with Drugs and Cosmetic Act 1940 and MDR 2017; a valid Medical Device license must be issued by the competent authority for the product.
How to ensure compliance with malicious code requirements in ESIC bid
Submit the Malicious Code Certificate confirming no embedded malware; demonstrate that hardware/software will not activate as malicious code; failure to provide results in contract breach and potential disqualification.
What is the scope of supply for this ESIC kit tender in Mumbai
Scope is strictly products supply of rapid test kits; no installation included unless specified; per‑order billing applies; delivery is to ESIC Post Graduate Institute of Medical Sciences and Research, MIDC Chakala, Andheri East, Mumbai.
What are the penalties or LD terms for delivery delays
Specific LD terms are not detailed; however, delivery terms reference option clause and potential schedule penalties under the contract; bidders should clarify LD rates during bidding and ensure delivery timelines align with consignee requirements.
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Documents 4
GeM-Bidding-9126788.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
CATALOG-Specification-2
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS