Sree Chitra Tirunal Institute for Medical Sciences & Technology Surgical Scissors Tender 2025 DST MDR 2017 Compliance

Tender Overview

Organization: Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST). Product: Surgical Scissors (V2) under the medical device category. Estimated Value: ₹3,500.00. Location: Kerala, India. Category: Surgical Scissors (V2) with MDR 2017 compliance. This tender seeks general and product-specific features for surgical scissors including material, shape, length, blade, and locking mechanism, plus mandatory certifications and batch test reports. The buyer emphasizes regulatory compliance and availability of test reports with each batch, along with unit manufacturing certifications. A key clause allows a 25% quantity variation during and after award, at contracted rates, with delivery timelines tied to the original order date.

Technical Specifications & Requirements

• Product Name: Surgical Scissors (V2) with medical-grade construction. Usage Environment: Medical facilities; sterile or reusable/disposable variants may be indicated. Make of Scissors: Manufacturer required with MDR 2017 compliance. General features: Medical-grade material, corrosion resistance, anti-glare coating, and blade details with length tolerance of ±2 mm. Key measurements: Blade length in mm (±2 mm), overall length, and angle in degrees. Certifications: MDR 2017 compliance, manufacturing unit certification, and availability of test reports per MDR for each batch. Warranty: Shelf life or reusable/disposable warranty term specified in years.

• Testing & Documentation: Submission of all essential certifications, licenses, and MDR test reports to buyer at bid submission or with supply.

• Quality/Compliance: All requirements to be met for Medical Device Rules, including ongoing batch testing and certification availability.

• Notes: No BOQ items available; emphasis on compliance and traceability.

Terms, Conditions & Eligibility

• EMD: Not explicitly stated; bidders should verify payment security as per vendor terms.
• Delivery: Option clause permits up to 25% quantity variation during or after contract; delivery period aligns with original order dates and extended period calculations.
• Payment Terms: Not specified; bidders should anticipate standard government procurement terms.
• Documentation: Provide GST, PAN, experience, financials, OEM authorizations, and MDR-compliant test reports as required at bid and with supplies.
• Warranty: Reusable/Shelf Life for Disposable products indicated, with warranty period in years.
• Penalties: Standard contractual penalties may apply for non-compliance or delayed delivery per the option clause.
• ATC/ATD: Buyer uploaded ATC document with terms; bidders must view and adhere.