Central Government Health Scheme Biochemistry Reagent Kit Tender India ISO 13485 MDR 2017 Compliance 2026

Tender Overview

Central Government Health Scheme (CGHS), Department of Health and Family Welfare, seeks procurement of Biochemistry Reagent Kits for Human Samples. Pack inclusions include calibrators and controls with each kit, and packaging specifies total volume per pack. Compliance requirements include Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 and a valid Medical Device license. Tender references indicate carted item specifications in the uploaded Excel, with EMD details not disclosed. Location is not stated; procurement targets national-level CGHS requirements. Key differentiators: mandatory calibration traceability certificates with calibrators and adherence to specified sample types and test forms.

CGHS procurement emphasizes strict conformity to regulatory standards, certification traceability, and packaging clarity. The tender emphasizes supplier readiness to provide compliant reagent kits, with emphasis on accurate documentation submission per buyer-uploaded ATC and Excel sheets. The absence of a defined BOQ implies emphasis on precise spec adherence and vendor capability to deliver standardized reagent kits in specified formats.

Technical Specifications & Requirements

• Standards & Certifications: Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 (as amended); must possess a valid Medical Device license issued by the competent authority; traceability certificates for calibrators.
• Product Details: Biochemistry Reagent Kits for human samples; include calibrator and control with each pack; form of reagent and type of test as specified in the tender; total volume per pack defined in packaging.
• Packaging & Documentation: Reagents supplied with documented calibrator traceability, and pack volume clearly stated; samples and test formats must align with CGHS requirements.
• Quality & Compliance: Kits must be compliant with regulatory framework; supplier to provide OEM/authorization where applicable; ensure packaging meets transport and shelf-life expectations.
• Submission Context: Follow Excel-based cart specifications; provide competitive rates aligned to carted item descriptions; MSME/NSIC exemptions may apply per terms.

Terms, Conditions & Eligibility

• EMD/Registration: EMD details not disclosed; MSME/NSIC exemption possible if supported by certificate.
• Documentation: Submit GST, PAN, experience certificates, financial statements, EMD/security deposit, technical bid documents, OEM authorizations as applicable per terms.
• Delivery & Payment: Delivery timeline not specified; payment terms not disclosed; bidders must reference Excel cart and ATC documents for schedule.
• Compliance & Audit: Provide traceability certificates for calibrators; ensure drugs and cosmetics and MDR compliance; include medical device license details.
• Selection Criteria: Adhere to product-specific requirements in cart; ensure bid aligns with buyer-uploaded ATC clauses; maintain competitive pricing per item descriptions.