LAW OF THE REPUBLIC OF MOLDOVA

of November 29, 2018 No. 279

About introduction of amendments to the Law on medical products No. 102/2017

The Parliament adopts this organic law.

Art. I. - In the Law on medical products No. 102/2017 (Official monitor of the Republic of Moldova, 2017, Art. No. 244-251, 389), with subsequent changes, to make the following changes:

1. In Article 2:

after the concept "medical product for diagnostics of in vitro" to add Article with the following concepts:

"the medical product made to order - any medical product intended for the specific patient according to the written instruction of the skilled health worker who establishes special product characteristics under own responsibility. Medical products of mass production which shall be adapted to conform to specific requirements of the instruction of the skilled health worker are not considered as the products made to order;

the medical product intended for clinical trials - medical product, held for use appropriately skilled health worker when performing the clinical trials specified in this law, in adequate clinical conditions for the person;

clinical data - the data concerning safety and/or efficiency, received in the course of use of medical product. Clinical data are obtained on basis:

- clinical testing of the corresponding medical product;

- clinical testing or other researches to which specialized literature which object is the similar medical product for which equivalence with the corresponding product can be proved refers;

- the published and/or unpublished reports on other clinical experiments made with this medical product or with similar product for which equivalence with the corresponding product can be proved;";

state the concept "incident" of the following edition:

"incident - any defect in work of medical product or violation of its characteristics and/or efficiency which can bring or which led to death or to serious damage to the state of health of the patient or user;".

2. In part (2) articles 4 Items e) - i) to recognize invalid.

3. Add the law with Articles 4-1 and 4-2 of the following content:

"Article 4-1. National agency of public health

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