Poland - Medical devices

Description

The subject of the order is the delivery of a brand new medical equipment, i.e. a bronchofiberoscope with a vision track, which does not bear traces of the use of medical equipment. The offered equipment must be a medical product within the meaning of the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended) and must be CE marked and have instructions for use in Polish. A detailed description of the subject of the contract is included in the offer form (chapter 2 of the ToR). This form contains, among others, the basic technical requirements (absolutely required parameters, which if not met will result in rejection of the offer - Table 1a) and the table of additional technical assessment (Table 2a), which is the basis for awarding the offer with points in the "technical assessment" criterion. In order to confirm that the deliveries offered correspond to the requirements specified by the Ordering Party, upon request the following should be submitted: a) appropriate manufacturer's catalogues (including catalogue numbers of the offered products), brochures or manufacturer's source materials/certificates in a legible and clear manner confirming that the technical and operational parameters described by the Ordering Party in chapter 2 to the ToR are met. If the above documents are prepared in a foreign language, the offer should be accompanied by the document(s) together with a translation into Polish; b) for medical devices offered under the contract, in accordance with the requirements of the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended); c) for medical devices offered under the contract, in accordance with the requirements of the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended).), the Economic Operators shall submit one of the following documents:- in the case of manufacturers, authorized representatives residing or having their registered office in the territory of the Republic of Poland - notification of products to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, - in the case of distributors and importers having their registered office in the territory of the Republic of Poland, a document confirming entry into the Register of Medical Devices, notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;(c) declaration(s) of conformity. The subject matter of the order is the delivery of a brand new medical equipment, not bearing traces of use, i.e. a cabinet for storing a bronchofiberoscope. The offered equipment must be a medical product within the meaning of the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended) and must be CE marked and have instructions for use in Polish. A detailed description of the subject of the contract is included in the offer form (chapter 2 of the ToR). This form contains, among others, the basic technical requirements (parameters required absolutely, which if not fulfilled will result in rejection of the offer - Table 1b) and the table of additional technical assessment (Table 2b), which is the basis for awarding the offer with points in the "technical assessment" criterion. In order to confirm that the deliveries offered correspond to the requirements specified by the Ordering Party, upon request the following should be submitted: a) appropriate manufacturer's catalogues (including catalogue numbers of the offered products), brochures or manufacturer's source materials/certificates in a legible and clear manner confirming that the technical and operational parameters described by the Ordering Party in chapter 2 to the ToR are met. If the above documents are prepared in a foreign language, the offer should be accompanied by the document(s) together with a translation into Polish; b) for medical devices offered under the contract, in accordance with the requirements of the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended); c) for medical devices offered under the contract, in accordance with the requirements of the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended).), the Economic Operators shall submit one of the following documents:- in the case of manufacturers, authorized representatives residing or having their registered office in the territory of the Republic of Poland - notification of products to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, - in the case of distributors and importers having their registered office in the territory of the Republic of Poland, a document confirming entry into the Register of Medical Devices, notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;(c) declaration(s) of conformity.

Opportunity closing date

28 October 2019

Value of contract

to be confirmed