Tender Overview
The Health & Family Welfare Department of Gujarat seeks supplier participation for hemoglobin test strips to be procured and delivered to Daodh (389130), Gujarat. Estimated EMD is ₹184,500, signaling a sizable procurement with quality and regulatory compliance at the forefront. The bid emphasizes MDR 2017 compliance, drug license validity, and manufacturing unit certification, ensuring medical device safety and traceability. A notable feature is the option clause allowing up to 25% quantity variation at contracted rates and a variable delivery timeline tied to the extended delivery period. Advance sample provision is required for buyer approval prior to supply, ensuring performance alignment with buyer standards. Sellers should note the absence of a BOQ and the potential for batch-level testing and labeling requirements. This tender targets suppliers capable of meeting medical device regulatory standards, packaging, and post-approval documentation. Key differentiators include MDR compliance verification, batch test reports, and shelf-life guarantees.
Technical Specifications & Requirements
- Product category: Hemoglobin test strips (medical device) for in vitro diagnostic use
- Key certifications: MDR 2017 compliance, valid drug license under Drugs and Cosmetics Act 1940, manufacturing unit certification, batch test reports per MDR
- Packaging & labeling: English packing inserts with each pack; standard storage conditions applicable
- Shelf life: minimum shelf life at delivery; shelf life after first opening must be stated
- Advance sampling: commitment to provide advance sample before supply; no BOQ items listed, so supplier must rely on product specs and regulatory credentials
- Quantity flexibility: up to 25% quantity variation during contract; delivery period adjustments as per option clause
- EMD status: ₹184,500; exemption for eligible MSE startups per ATC clauses
- Delivery scope: governed by option clause and original delivery window; extended periods may apply
- Quality assurance: batch test reports for each supplied batch; compliance with MDR testing standards
Terms, Conditions & Eligibility
- EMD: ₹184,500; exemptions allowed for MSE/Startup units with valid NSIC/CSPO certificates
- Experience/turnover: startups may qualify for turnover/performance exemptions if Gujarat state micro/small startup; otherwise standard qualification applies
- Delivery terms: delivery begins from last date of original delivery order; option clause may extend delivery time with minimum 30 days
- Payment terms: (not specified in details); bidders should anticipate standard government terms (to be clarified in ATC)
- Documents: GST, PAN, experience certificates, manufacturing licenses, batch test reports, OEM authorizations, and MDR compliance certificates as applicable
- Penalties: LD or penalties not explicitly described; compliance with delivery schedules and quality tests critical
- Warranty: not explicitly detailed; likely tied to MDR compliance and batch testing
