of April 26, 2012 No. 92
About medical products
The Parliament adopts this organic law.
(1) This law establishes legal and institutional basis for control of the medical products put into operation and used, the active implanted medical products, medical products for diagnostics of in vitro (further - medical products), and also for control of sales activity, to distribution of medical products and rendering the related services.
(2) This law is applied also to accessories of medical products when they are used together with medical product for ensuring its use on the provided appointment. For the purpose of this law of accessory are considered as medical products.
(3) the Purpose of this law is providing optimal conditions for issuance of high-quality, effective and safe medical products to guarantee quality of the provided medical services, protection and strengthening of health of the population.
For the purpose of this law the basic concepts used in it mean:
medical product - the tool, the device, the device, material or other subject used separately or in combination, including the software intended by the producer to special use for diagnostics and/or in the therapeutic purposes and necessary for proper functioning of medical product, intended by the producer for application to the person on purpose:
- diagnostics, prevention, observation, treatment or simplification of disease;
- diagnostics, prevention, current control, treatment, decrease in sharpness of course or compensation of injuries or mutilations;
- researches, replacements or modifications of anatomic form or physiological process;
- conception regulations,
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The document ceased to be valid since October 14, 2017 according to article 22 of the Law of the Republic of Moldova of June 9, 2017 No. 102