AIIMS Raipur Chemical Indicator for Steam Sterilization Tender 2025 ISO 13485 MDR IS 11140

Tender Overview

The procurement is issued by the All India Institute Of Medical Sciences (aiims) in Raipur, Chhattisgarh for chemical indicators used in steam sterilization processes. The scope covers chemical indicator products with requirements spanning product type, indicator signal, presentation, and minimum shelf life. The bid emphasizes compliance to MDR 2017, an active Medical Device license under the Drugs and Cosmetics Act, and IS/ISO 11140 conformity, with an EMD of ₹2,700 and a potential pre-approval advance sample. The tender also mandates ISO 13485 certification and batch test reports, ensuring a standardized quality framework. This notice includes mandatory supplier documentation and advance sample submission, highlighting a robust regulatory compliance expectation. The on-site delivery context and sample approvals prior to supply underscore a controlled procurement for AIIMS health care operations.

Technical Specifications & Requirements

• Class/Type of Chemical Indicator and Presentation of Indicator as key product attributes
• Shelf life: months from manufacture and minimum remaining shelf life at delivery
• Indicator Signal details for user interpretation
• Conformity to IS/ISO 11140 and alignment with MDR 2017 amendments
• ISO:13485 certification status and validity
• Medical Device license under Drugs and Cosmetic Act, with supplier to present at bid or with supplies
• Test reports for each batch per MDR 2017 and advance sample provision before supply
• Advance sample requirement prior to commencement of supply
• Documentation: certifications, licenses, and test reports submitted with bid or along with supplies
• No BOQ items present; emphasis on regulatory and quality controls throughout

Terms, Conditions & Eligibility

• EMD: ₹2,700 as bid security
• Experience: bidder or OEM must have supplied similar category products to government/PSU for at least 3 years, with supporting contracts
• Turnover: bidder/OEM must meet minimum average annual turnover criteria as specified, with audited balance sheets or CA certifications
• OEM authorization: required where distributors submit bids; include OEM authorization details
• Compliance: must provide advance sample, IS/ISO 11140 conformity, and MDR 2017 compliance documents
• Purchase terms allow option quantity adjustments up to 50% during contract and delivery period extensions under specified calculation
• Mandatory submissions: GST, PAN, experience certificates, financials, EMD documents, OEM authorizations, and technical compliance certificates
• Warranty/after-sales: not explicitly stated beyond MDR/ISO standards; ensure batch test reports for each delivery