The obligation to notify an introduction of medical devices, an active medical devices for implantation, an in vitro diagnostic medical devices, systems and treatment kits composed of medical devices, hereinafter referred to as products, are governed by the provisions of Law on medical devices.
The manufacturer or authorized representative residing or domiciled in Poland notifies the introduction of a product to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at least 14 days prior to placing on the market or transferring to the evaluation.
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