Zad. 1 – Stymulator zewnętrzny jednokanałowy dla I Oddziału Kardiologii

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3.3. Contracting Authority requirements regarding the subject matter of the contract: 1. the offered medical device must have approvals, certificates and be registered in accordance with the provisions of law requiring possession of approvals, certificates and registration, 2. the offered medical device must be introduced to the market and put into use in accordance with the requirements of the Act of 7 April 2022 on medical devices (Journal of Laws of 2024, item 1620, as amended), 3. the offered medical device must comply with standards or technical specifications applicable to this device; In the event that the offered medical device does not require notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Contractor is obliged, at its own expense and within its own scope, to perform all activities necessary to satisfy all legal requirements related to the introduction of the device to the market and its use within the territory of the Republic of Poland. The Contractor is obliged to perform such activities within the time limits resulting from the applicable provisions of law and to provide the Contracting…

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