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LAW OF THE REPUBLIC OF MOLDOVA

of June 9, 2017 No. 102

About medical products

(In edition of the Laws of the Republic of Moldova of 24.05.2018 No. 79, 27.07.2018 No. 140, 29.11.2018 No. 279)

The parliament adopts this organic law.

Chapter I. General provisions

Article 1. Subject and purpose of the law

(1) This law establishes prerequisites 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 optimum 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.

Article 2. Basic concepts

For the purpose of this law the basic concepts used in it mean:

accessory – any product which, without being medical product, is specially intended for its application together with medical product, for the purpose of use of the last according to the appointment provided by the producer;

medical product – any tool, the device, the device, material or other product used separately or in combination, including the software, necessary for its proper functioning, intended by the producer for use in relation to human body on purpose:

a) diagnostics, prevention, observation, treatment or decrease in sharpness of course of disease;

b) diagnostics, prevention, current control, treatment, decrease in sharpness of course or compensation of injuries or limited opportunities;

c) researches, replacements or modifications of anatomic form or physiological process;

d) conception regulations and which basic provided purpose is not implemented by impact by pharmacological, immunological or metabolic means in human body or on it, but to functioning of which these means can promote;

active medical product – medical product which functioning depends on source of electrical energy or any other power source, except for 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;

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, used separately or in combination, developed by the producer for application out of human body with research purpose of the tests including taken from human body of donor blood and fabric, only or mainly for the purpose of receipt of any following information:

a) about physiological or pathological condition or congenital anomalies;

b) about degree of safety and compatibility with potential receivers;

c) for monitoring of therapeutic actions;

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