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LLC «GXP»

Carrying out services for manufacturers of Medical devices (MD), Medical devices for in-vitro diagnostics, active medical devices, for further implantation in Ukraine

GXP is your trustworthy and reliable Authorized Representative in Ukraine, fulfilling your company’s needs on its way to success

In accordance to the Ukrainian technical regulations, if a manufacturer of medical devices, medical devices for in-vitro diagnostics or other active medical devices is not a resident of Ukraine, he or she must seek an authorized representative on the territory of Ukraine

The authorized representative means — any legal person or sole proprietor who is a resident of Ukraine and duly authorized by the manufacturer to act on his behalf with regard to the obligations indicated in the Agreement and Power of Attorney

The main functions of the authorized representative are described in the Technical Regulations of Medical Devices No. 753, the Technical Regulations of In-Vitro Diagnostic Medical Devices No. 754 and the Technical Regulations of Active Implantable Medical Devices No. 755, respectively

Why GXP?
    • We are a skilled team of experts in the area of medical regulations and its devices. We are fluent in the requirements of national and European legislation.
    • We provide turnkey services