Government Medical College and Hospital Chandigarh Chemical Indicator Tender 2025 ISO 13485 MDR IS 11140

Bidders must satisfy MDR 2017 compliance, ISO 13485 certification, and IS/ISO 11140 conformity. Provide batch test reports, Medical Device license under the Drugs and Cosmetic Act, and OEM authorizations if needed. Submit integrity pact and non-blacklisting affidavit for bids over ₹5 lakhs, with advance sample provision.

Required documents include GST and PAN, experience certificates for similar medical devices, financial statements, EMD proof, ISO 13485 certificate, MDR batch test reports, and Medical Device license. Include OEM authorization if bidding as distributor and ensure IS/ISO 11140 conformity evidence.

Indicators must comply with MDR 2017 amendments, IS/ISO 11140 conformity, and maintain ISO 13485 quality management certification. A valid Medical Device license under Drugs and Cosmetic Act must accompany the bid, along with batch-wise MDR test reports for supplied items.

The buyer requires advance sample submission for approval before commencement of supply. Ensure samples reflect the same batch and conform to MDR and IS/ISO 11140 standards. Include in bid documentation the process and lead time for sample approval.

Scope is strictly the supply of chemical indicator goods; no installation or ancillary services are included. Bid prices must cover all costs related to delivery, packaging, and compliance with MDR, ISO 13485, and IS/ISO 11140 requirements.

Bidders must submit an integrity pact and a non-blacklisting certificate/undertaking. For bids above ₹5 lakhs, provide a notarized affidavit confirming no government or partner blacklist status; this must be issued before bid opening.

Eligibility includes MDR 2017 compliance, ISO 13485 certification, Medical Device license, batch test reports per MDR, and demonstrated experience supplying chemical indicators. Applicants should provide GST, PAN, financials, and OEM authorizations where applicable for procurement eligibility.