LAW OF THE REPUBLIC OF MOLDOVA

of April 26, 2012 No. 92

About medical products

The parliament adopts this organic law.

Chapter I General provisions

Article 1. Subject and purpose of the 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 optimum 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.

Article 2. Basic concepts

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,

these means which are not achieving the main expected objective in human body or on it by means of pharmacological, immunological or metabolic means, but function of which can help;

active medical product - medical product which functioning depends on source of the electrical energy or any power source other than the energy generated by human body or gravity;

the active implanted medical product - the active medical product intended for introduction fully or partially by medical or surgical intervention in human body or in anatomic opening and leaving on the place of introduction after the procedure;

accessory - product which, without being medical product, is intended by the producer especially for use together with medical product that the last could be applied according to the appointment provided by his producer;

medical product for diagnostics of in vitro - the medical product which is reagent, reaction product, the calibrator, control material, set, the tool, the device, the device or system, applied separately or in combination, intended by the producer for use out of organism with research purpose of tests, including the donor blood and fabric extracted from human body mainly or only for the purpose of receipt of information:

- about physiological or pathological condition or about congenital anomalies;

- for determination of safety and compatibility with the potential recipient;

- for monitoring of therapeutic actions.

Reservoirs for tests are considered as medical products for diagnostics of in vitro. Reservoirs for tests - the products of vacuum or not vacuum type intended by the producer especially for the room in them the samples taken from human body directly after withdrawal and for their storage taking into account the subsequent research for diagnostics of in vitro;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info