Tenders Are Invited For Successive Delivery Of Tests, Packaging And Sterilization Consumables, Respectively, ... in Poland

Work Detail

1. The Subject Of The Order Is The Successive Delivery Of Accessories For The Sterilization Process.2. The Offered Goods (Point 3.1 Of The Swz) Must: 2.1. Meet The Conditions For Placing On The Market And Putting Into Service Provided For In The Medical Devices Act Of April 7, 2022 (Journal Of Laws Of 2024, Item 1222, As Amended - Hereinafter Referred To As The Medical Devices Act), Confirmed By Current Documents (I.E.: Complete Applications Or Notifications To The President Of The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products, Safety Data Sheets, Ce Certificate, Declarations Of Conformity, Certificates) - For Those Goods That Require It In Accordance With Applicable Law;2.2. Have Documents Allowing Them To Be Traded And Used In Poland - Including A Ce Certificate And Documents Confirming That These Goods Meet The Standards Required By Law - In The Case Of Goods Not Subject To The Provisions Of The Medical Devices Act Or The Pharmaceutical Law;2.3. For Products Classified As Cosmetics In Accordance With Regulation Of The European Parliament And Of The Council / Ec / No. 1223/2009 Of November 30, 2009, Have A Notification On The Cosmetic Products Notification Portal (Cpnp Portal);2.4. Be New, Free From Defects, Packed In Original Packaging. The Labels And Packaging Of The Goods Should Contain All Required Information In Accordance With The Medical Devices Act, The Pharmaceutical Law Or Other Provisions Of Generally Applicable Law Relating To Them;2.5. Have A Validity Period Of At Least 12 Months From The Date Of Its Delivery - In The Case Of Goods With A Limited Validity Period;2.6. For Part 1 Of The Order, Item: 1 To 6 In The Table Included In The Sopz (Annex No. 3 To The Swz) The Ordering Party Requires That The Subject Of The Order Have A Ce Declaration Of Conformity Issued By The Sleeve Manufacturer Confirming Compliance With The Following Standards: Pn-En Iso 11607-2, Pn-En 868-5. The Contractor Should Confirm This Requirement With Appropriate Documentation, In Accordance With The Provisions Of Point 8.1.2 Of Swz.3. The Contractor Is Obliged To Absolutely Guarantee The Fulfillment Of The Quality Conditions Specified In The Production Permit Or Other Decisions Established By The Ministry Of Health, Based On Which The Goods Were Admitted To Trading In The Territory Of The Republic Of Poland, And To Comply With The Expiry Dates For The Delivered Goods. 4. In The Case Of Each Part Of The Order Referred To In Point 3.1 Of The Swz, The Contractor Is Obliged, Free Of Charge, To: 4.1. Delivering The Goods Successively To The Registered Office Of The Ordering Party (Ul. Montelupich 4, Kraków), Based On Orders Specifying The Assortment And Quantity, Within No Longer Than 5 Business Days From The Moment Of Placing The Order, Provided That Deliveries Will Be Accepted On Business Days (Monday To Friday, Excluding Public Holidays), From 8:00 A.M. To 2:00 P.M.;4.2. Bringing In And Unloading The Goods In The Room (Room

Contact Information