How to Open a Prosthetics Center in Ukraine: Medical Licensing and Manufacturing
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Requests to open private prosthetics and rehabilitation centers in Ukraine are increasing every day. In practice, however, investors and founders of medical startups face a strict bureaucratic reality: prosthetics is not merely a high-tech manufacturing activity, but also a form of medical practice that is subject to mandatory licensing by the Ministry of Health of Ukraine.
A prosthetics center is a facility assessed under three different regulatory frameworks at the same time:
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as a medical practice;
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as a manufacturing operation;
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as a facility subject to enhanced accessibility requirements for people with amputations.
A single legal or regulatory inconsistency — ventilation for working with resins installed in the wrong area, an incorrectly calculated room size for plaster casting, or the absence of an accessibility assessment specifically covering this category of patients — may result in the Ministry of Health returning the documents for revision. Meanwhile, while these issues are being corrected, rent and staff payroll expenses continue to accumulate.
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