ESIC Jammu HIV/HBV/HCV Rapid Test Kits Tender 2026 Jammu & Kashmir - MDR-MDR 2017 Compliance & Medical Device License

Tender Overview

Organization: Employees State Insurance Corporation (ESIC) – Jammu, Jammu & Kashmir. Procuring a range of human rapid test kits (HIV/Syphilis/HBV/HCV), dengue/malaria/typhoid rapid kits, rapid pregnancy tests, blood collection tubes and needles. Estimated value not disclosed; EMD ₹16,000. Location: Jammu, Jammu & Kashmir 180001. Scope emphasizes ISI/ISO-aligned, MDR 2017 compliant medical devices with batch testing and reputable labeling. Unique aspects include mandatory control provisions per pack and trade compliance. This tender targets suppliers capable of meeting regulatory standards and providing post-award advance samples for approval. The tender highlights the option clause allowing up to 25% quantity variation and extended delivery windows, with sample approval timelines clearly defined.

Technical Specifications & Requirements

• Product categories: Rapid Test Kits for HIV, Syphilis, HBV, HCV; Dengue, Malaria, Typhoid; Rapid Pregnancy Test Kit; Blood Collection Tubes; Blood Collection Needles (V2).
• Testing parameters: Type of test kit, detection type, testing method, result time; include positive/negative controls per pack.
• Packaging & shelf life: Number of tests per pack; residual shelf life requirements; minimum shelf life at delivery.
• Certifications & licenses: Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended; valid Medical Device license from competent authority; advance sample provision and batch test reports per MDR 2017.
• Technical data expectations: Sample type, kit description, sensitivity, specificity; manufacturer certification; test reports for each batch; advance sample provision pre-bulk supply.
• Quality & testing: Advance sample testing at designated AHSP labs; if not available, NABL/Govt labs; testing charges borne by seller for non-designated labs.
• Delivery & acceptance: Delivery period linked to original order with option for extension; 7 advance samples for buyer approval; 10 days for modification feedback; LD terms apply for deviations.

Terms, Conditions & Eligibility

• EMD: ₹16,000; payment terms not explicitly stated beyond EMD requirement; bid compliance with GST/PAN and regulatory licenses is implied.
• Delivery terms: Option to increase quantity up to 25% during contract; delivery timeline adjusts with extension rules; extended time formula provided.
• Sample/approval: Submit 7 advance samples within 7 days of award; approval or modification list within 10 days; bulk supply must align to approved sample; non-compliance may trigger contract termination.
• OEM/Imported products: If imported, OEM or authorized seller must have registered Indian office for after-sales service.
• Inspection & testing: Advance sample tested at AHSP labs; if not, Govt/NABL labs may be used; external testing costs borne by seller.
• Documentation: Provide all certifications, licenses and test reports at bid submission or with supplies as required by buyer.
• Warranty & after-sales: MDR compliance, manufacturer certification, and batch test reports required; advance sample approval prerequisite before bulk supply.