ORDER OF THE MINISTRY OF HEALTH, WORK AND SOCIAL PROTECTION OF THE REPUBLIC OF MOLDOVA

of March 21, 2018 No. 211

About system of supervision of medical products

Based on provision of Art. 16 of the Law No. 102 of June 9, 2017 on medical products, and also based on Item 9 of the Regulations on the organization and functioning of the Ministry of Health, work and social protection approved by the Order of the Government No. 694 of August 30, 2017 POSTANOVLYAYU:

1. Approve Regulations on system of supervision of medical products.

2. Heads of medical and sanitary organizations, irrespective of pattern of ownership and legal form to oblige to inform the Agency on drugs and medical products on any incident according to this resolution.

3. To the agency on drugs and medical products:

1) to provide methodological support on implementation of this resolution;

2) quarterly to report to the Ministry of Health, work and social protection to the 10th day of the next month on the registered incidents and the taken measures.

4. Place this resolution on the web page of the Ministry of Health.

5. Publish this resolution in the Official monitor of the Republic of Moldova.

6. Declare invalid the Order No. 820 of 27.10.2017. (Official monitor of the Republic of Moldova No. 390-395, 2017, Art. 1987).

7. To impose control of execution of this resolution on service of medicines and medical supplies.

Approved by the Resolution of the Ministry of Health of the Republic of Moldova of March 21, 2018 No. 211

Regulations on system of supervision of medical products

I. General provisions

1. The regulations on system of supervision of medical products (further - the Provision) are developed according to Art. 16 of the Law No. 102 of June 9, 2017 on medical products,

2. For the purpose of this provision the terms determined according to the legal acts stipulated in Item l of this provision as well as the following concepts are used:

supervision of use - set of measures by means of which safety in functioning and qualitative indexes, according to objective during all useful life of medical product and identification of incidents in the course of use is ensured and proves to be true;

incident - defects which bring or can lead to death, injury or serious damage of the state of health of the patient, user, the third parties or which negatively influence quality of the environment, including defects which when repeating lead to violations in medical activities, to material and temporary losses, and losses of other nature;

the user - all medical and sanitary organizations, irrespective of pattern of ownership and legal form, including their personnel participating in use of medical products such as personnel of clinic (doctors and nurses), paramedical personnel (radiologists and kinesitherapists) and personnel of support services.

the operator - the competent person which manages medical product;

use error - action or failure to act which result is other than the result specified by the producer, or expected by the operator of medical product;

the product malfunction - means any discrepancy in that, as for identity, reliability, safety or qualitative indexes of product which is investigation subject, including defective functioning, errors of use or discrepancy of information provided by the producer;

corrective action - means action for elimination of the reason of situation, possible or existing, discrepancy or other undesirable situation;

corrective action in - means the corrective action taken by the manufacturer for the technical or medical reasons for the prevention or decrease in risk of the serious incident caused by the product delivered on the market;

the notification for the purpose of safety - means the message, the sent message to the manufacturer or the consumer, concerning implementation of the adjusting measures aimed at safety on the place;

inefficient use - action or failure to act from the operator or the user of medical products, as a result of behavior which goes beyond sides of any control facility of risk;

the response - means any measure directed to return of product which was already provided to use to the end user;

withdrawal - means any measure directed to provision hindrance further on the market of the product which is in supply chain;

3. The purpose of the Resolution is improvement of protection of health and safety of patients and users by assessment of incidents about which the message was received, and if it is applicable, determination of information which can be useful to the prevention of their repeating or to mitigation of the consequences of incidents of this kind. The provision affects incidents in which medical devices with marking about compliance of SM or CE were involved.

4. In system of supervision of medical products producers and their authorized representatives, the Agency on drugs and medical products (further - the Agency), the notified bodies, users and other persons interested in long safety of medical devices are responsible.

II. Procedure of the message on incidents and acceptance of necessary measures

5. The agency registers and on a centralized basis estimates any information concerning the listed below incidents with participation of medical products of I, IIa, IIb and III classes:

1) any action in work or deterioration in characteristics and/or efficiency of the medical device, and also any case of discrepancy in marking or maintenance instructions which can bring or which led to death or serious damage of the state of health of the patient or user;

Any reason of technical or medical nature connected with characteristics or qualitative indexes of the device for the reasons specified in the subitem 1) of this Item leads 2) to systematic withdrawal from the market of devices of the same type by the manufacturer.

6. The agency registers and on a centralized basis estimates any information concerning the incidents provided below with participation of medical devices for diagnostics of "in vitro":

1) any defect, any failure / deterioration in characteristics and/or efficiency of the medical device for diagnostics of "in vitro", as well as any inappropriate marking, the brochure or the instruction capable to bring or which led, directly or indirectly, to death or serious damage of the state of health of the patient or user;

2) any reason of technical or medical nature connected with characteristics or qualitative indexes of the device for the reasons specified in the subitem 1) of this Item which can lead to systematic withdrawal from the market of devices of the same type by the manufacturer.

7. The agency registers and on a centralized basis estimates any information concerning the incidents provided below with participation of the active implanted medical products:

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