Quotation Subject Matter Sample Clauses

Quotation Subject Matter. 2.1 Sellers are invited for the supply of Surgical Stapler for Endoscopic Surgery under the NPS, the product types and categories required by the Authority are set out in Schedule A. Sellers are invited to offer their Goods which rightly match with the required product types and categories, by completing all details and prices in Schedule A and the Schedule of Compliance in Schedule B. Seller should note that any Goods quoted in Schedule A must have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) within 18 months immediately preceding the Closing Date. Seller must complete the consumption details for each of the Goods it proposes to supply in Schedule A. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.2 Any Goods to be supplied by the Seller must meet the following product standards and requirements: (a) the Goods offered must comply with the standard of British Standard Institution (BSI) of general requirements for Sphincterotome, Stent Introducer and Cannulation Catheter or equivalent standard of International Organization for Standardization (ISO). Sellers must indicate the specific BSI or ISO standard applicable to each offered products in Schedule A, and confirm compliance with the applicable standards. Upon request, Sellers are required to provide to the Authority documentary evidence showing compliance with the relevant standards; (b) the Seller must, for each of the Goods quoted in Schedule A, submit with its Standing Quotation copies of 2 sets (each set in separate file) of the following: (i) certified true copy of manufacturer license issued by the Government or Health Authority of the country of origin; (ii) certified true copy of the authorized certification of compliance to ISO 13485 (latest version), Food and Drug Administration (FDA)/ Product’s compliance with European Commission legislation (CE)//BSI or other equivalent international standards in production and quality-management system; (iii) certified true copy of certifying compliance with FDA 510(K)/CE or other equivalent international standards for listing of each offered product in Schedule A. 2.3 If a Seller is not the manufacturer of the Goods offered in Schedule A, the Seller must submit with its Standing Quotation a written undertaking issued by the manufacturer of the Goods evidencing the manufacturer’s agreement to supply such Goods to the Seller should the Seller’s Standin...