of June 9, 2017 No. 102
About medical products
The Parliament adopts this organic law.
(1) This law establishes premises for introduction on the market and commissioning of medical products, legal and institutional base for control and supervision of medical products by their provision in the market and use, and also for supervision of sales activity, to distribution of medical products and rendering the related services.
(2) the Purpose of this law is providing optimal conditions for provision in the market of high-quality, effective and safe medical products, for quality assurance of the provided medical services, protection and promotion of health of the population.
(3) This law is applied to medical products, the active implanted medical products, medical products to diagnostics of in vitro. For the purpose of this law of accessory are considered as medical products.
(4) This law is not applied to:
a) to drugs;
b) cosmetic products;
c) human blood, products from blood of the person, to human plasma or blood cells of human origin or products which at the time of their provision in the market include such products, and also to derivative products of blood, plasma or cages;
d) to the transplants, fabrics or cages of human origin and products including fabrics or cages of human origin or received from them;
e) to transplants, fabrics or cages of animal origin, except for the products made with use of impractical fabrics of animal origin or the impractical products received from fabrics of animal origin;
f) to the individual protection equipment falling under action of the Order of the Government about approval of some technical regulations No. 138/2009. In case of decision making that the similar product falls under operation of this law, its basic provided purpose is considered.
For the purpose of this law the basic concepts used in it mean:
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