West Central Railway Spinal Needle (V2) Procurement Jabalpur Madhya Pradesh 201 MDR Compliance 2017

Bidders must demonstrate MDR 2017 compliance, possess Drug/Medical Device license under the Drugs and Cosmetic Act, provide manufacturing unit certification, and submit product test reports. Include OEM authorizations, advance sample (pre-approval) and all required documents as per ATC. Ensure GST terms are understood, and supply scope remains goods-only.

Required documents include GST registration, PAN, MDR compliance certificates, drug/license under Drugs and Cosmetic Act, manufacturing unit certification, product test reports, OEM authorizations, and demonstration of MSME purchase preference eligibility if applicable. Additional tender ATC documents must be uploaded with bid.

Specifications include hub material conforming to IS 319, medical-grade cannula material, smooth-storing Stilette wire, conical fitting, precise needle gauge and length as per item, and sterility/packaging compliance aligned with MDR 2017 requirements.

Advance sample submission is required prior to commencement of supply, to obtain buyer approval. The exact timeline is defined in the bid ATC; ensure samples reflect MDR-compliant packaging and documented test results.

MSE qualification requires the bidder to be the manufacturer of the offered spinal needle, with documentary evidence uploaded. If L-1 is not an MSE, an MSE seller may be eligible for 25% of the contract value under policy if within the defined margin.

Mandatory licenses include Drug/Medical Device license under the Drugs and Cosmetic Act, MDR 2017 compliance certificates, and manufacturing unit certification. All licenses must be valid and current at bid submission and delivery, with test reports available per MDR requirements.

Scope is strictly the supply of goods (spinal needle V2) with required packaging, sterility, and lead-time adherence. No service components are included; the bid must cover all cost components within the quoted price.

Include MDR 2017 compliance, IS 319 hub conformity, drug/medical device license, manufacturing unit certification, product test reports, and any OEM authorizations. All documents should be current and submitted with bid or along with supplies per buyer requirement.