Law nr. 92 Adopted on 26.04.2012
Chapter I - GENERAL PROVISIONS
Article 1. Object and purpose of law
(1) This Act establishes the legal and institutional framework for controlling medical devices, active implantable medical devices, in vitro diagnostic medical devices in use and used hereinafter medical devices and for controlling the marketing, distribution and supply of services in medical devices.
(2) The provisions of this law apply to medical devices and accessories when accessories are used with a device to allow its use for its intended purpose. In this law, the accessories are interpreted as medical devices.
(3) The purpose of this law is to ensure optimal conditions for providing quality medical devices on the market, effective and safe, to ensure quality of medical services, protect and promote health.
Article 2. Definitions
In this law, the following definitions apply:
Medical device - instrument, apparatus, equipment, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and / or therapeutic purposes and necessary for proper application , for the manufacturer to be used for human purposes:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease;
- Diagnosis, prevention, monitoring, treatment, alleviation or compensation for an injury or handicap,
- Investigation, replacement or modification of anatomy or physiological process;
- Control of conception,
and fulfills its principal intended action is not in / or the human body by pharmacological, immunological or metabolic means, but whose operation can be assisted by such means;
active medical device - medical device whose operation is based on a source of electricity or any power source other than that generated by the human body or gravity;
active implantable medical device - medical device asset is intended to be placed, wholly or in part, by medical or surgical intervention, and remain implanted in the human body or in its hole;
accessory - article, although not a medical device is particularly intended to be used with a device to enable its use for the purposes intended by the manufacturer;
in vitro diagnostic medical device - medical device is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer for use in vitro examining evidence, including blood and tissue donations, derived from the human body, solely or mainly for the purpose of obtaining information:
- Physiological or pathological status of an anomaly or defect;
- To determine the safety and compatibility with a potential recipient;
- To monitor therapeutic measures.
Specimen receptacles are considered in vitro diagnostic medical devices. Sample containers are vacuum devices or not, specifically intended by the manufacturer to keep the original and preservation of evidence obtained from the human body for in vitro diagnostic examination;
individual device custom - made medical device as prescribed by qualified medical practitioner that develops under its construction characteristics of the device intended for a particular patient. Limitation may also be issued by any other person authorized by virtue of his professional qualifications. Medical device product range to be adapted to meet the specific requirements of a qualified medical practitioner prescription or other authorized person is not considered individually control device;
device intended for clinical investigation - device intended to be used by qualified medical practitioner when a clinical investigation result in an appropriate clinical setting. The goal of achieving clinical investigation, any person who, by virtue of his professional qualifications, is authorized to conduct such investigations will be accepted as equivalent to qualified medical practitioner;
conformity assessment - a process which evaluates and demonstrates that there were specific requirements for medical devices;
Registration - a document completed action providing objective evidence of activities performed or results in medical devices;
Essential requirements - requirements established by national technical regulations for national security, life safety of medical devices, health and human security for the animal and plant, environment and material goods for the purpose of protection of consumer interests, including prevention practices misleading consumers regarding the composition, purpose, origin, quality and safety of medical devices;
notified body - conformity assessment, legal entity based in Moldova, designated Medicines and Medical Devices Agency and approved by the Ministry of Health for the evaluation of medical devices compliance, according to the procedure established by the Government;
monitoring of use - set of measures that ensure and confirm the reliability and performance, as intended, the whole life of the detection device and incidents in their use;
incident - defects that cause or could cause fatalities, injuries or serious damage to health of the patient, user, or third persons that affect environmental quality and defects which, through repetition, produce disturbances in the medical, economic loss , time and other data;
register - all the information documented, entered manually and / or automated information system, on medical devices, manufacturers and suppliers of medical devices;
manufacturer - natural or legal person having the responsibility to design, produce, pack and label medical device delivered to the market under his own name, whether this function is performed by itself or by a third party on its behalf ( responsible for making available on the market). The term also applies to natural or legal person who assembles, packages, processes, refurbishes and / or label products and / or their assigned destination medical device with the intention of making available on the market under his own name. The term does not apply to persons who are not producers for the purposes of this definition, assembles or adapts devices already on the market care for the patient;
intended purpose - use medical device is intended according to data provided by the manufacturer on the label, instruction and / or promotional materials (trade literature);
making available on the market - the market supply of medical devices for distribution, consumption or use during a business in return for payment or free;
marketing - making available on the market for the first time a medical device;
authorized representative - natural or legal person established in Moldova, specifically designated by the manufacturer and acting and can be contacted by authorities and bodies empowered instead of the manufacturer on its obligations specified in this Law;
device for self - medical device intended by the manufacturer for use at home;
device for performance evaluation - medical device designed by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyzes or in other appropriate locations outside their offices;
clinical data - information on safety and / or performance from the use of a medical device. Clinical data obtained from:
- Clinical investigation of the device concerned;
- Clinical investigation or other studies referred to in the literature, having as its object a device similar equivalence can be demonstrated with the device;
- Published and / or unpublished reports on other clinical experience, or the device in question, or a similar medical device for which equivalence can be demonstrated with the device;
measuring device according to - the instrument, equipment, installation, reference material and possessing standardized metrological characteristics of measuring which provides independently or in combination with one or multiple devices.
Article 3. Medical devices incorporating medicinal substances
(1) If a device is designed for taking drugs, it is regulated by this law, without prejudice to the law on drugs.
(2) If such a device is made available on the market in a form the device and form a single drug product designed exclusively for use in combination once and is not reusable, that device will be considered drug.
(3) Where a device incorporates as an integral part a substance which, if used separately, can be considered a medicinal product constituent or a medicinal product derived from human blood or plasma and can have on human body action ancillary to that of the device, that device is subject to this law.
Article 4. Providing market
(1) Medical devices can be made available on the market, put into service or used unless they have undergone conformity assessment and are registered under this law, so as not to affect the safety and health of patients, users and, where appropriate, others and the environment.
(2) manufacturers of medical devices are required, before putting into operation and use of medical devices have reacted to these devices undergo conformity assessment procedures for conformity assessment according to medical devices, set by the Government, transposing EU directives applicable to medical devices.
(3) medical devices sold, distributed, be put in place and maintained for use in the intended purpose.
(4) medical devices must meet the essential requirements of the Government decision to implement European directives applicable to medical devices. Medical devices are deemed to comply with the essential requirements in case the corresponding harmonized European standards.
Article 5. Certification and registration procedures
Medical devices are certified and / or recorded on conformity assessment procedures established by the Government.
Article 6. Exceptions to application
This law does not apply:
b) cosmetic products;
c) human blood, human blood products, human plasma or human blood cells or devices incorporating, when making them available on the market such products derived from blood, plasma or cells;
d) transplants or tissues or cells of human origin and products incorporating or derived from tissues or cells of human origin;
e) transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissues viable or viable products derived from animal tissue;
f) personal protective equipment. If it decides that such a product falls within this law, shall be taken into account in particular the main intended purpose.
Chapter II- Authorities and Body Mandated in Medical Devices
Article 7. Medicines and Devices Agency Medical
(1) Medicines and Medical Devices Agency (hereinafter Agency) under the Ministry of Health, with legal person status, authorized to exercise management functions of medical devices, with priority objectives focused on implementing the legal framework has the following main areas of activity :
a) monitoring of supplies and equipment to medical devices, especially in public medical institutions, and implementation of national programs;
b) market surveillance procedures under this law, including by authorizing the importation of medical devices;
c) monitoring the quality of products on the market;
d) ensuring health information system in medical devices;
e) ensuring the implementation of quality standards and protection;
f) monitoring and verification of results on management of medical devices in accordance with procedures approved by the Government;
g) creating and maintaining the register of medical devices according to Law. 71-XVI from 22 March 2007 on registers;
h) conducting centralized procurement of medical devices for public health care institutions.
(2) Rules of organization and functioning, structure and limit the Agency is approved by the Government.
(3) Agency is the competent authority and decision-making in medical devices.
Article 8. Commission for Medical Devices
(1) Commission for medical devices is a body of experts in medical fields, which can be trained and experts in fields other than medical.
(2) Commission for medical devices, together with the Agency organize the clinical investigation of medical devices on human subjects, according to regulations.
(3) Composition, organization and powers of the Commission for medical devices approved by the Government.
Article 9. The Minister for Health
In medical devices, the main tasks of the Ministry of Health are:
a) approve the nomination list of notified bodies on proposals by the Agency;
b) develops and promotes policies on medical devices.
Article 10. Conditions and additional documents Licensing Activities medical devices
(1) Production, marketing, technical support and repair of medical devices, including optics, is carried out under license issued by the Licensing Board as provided by law.
(2) The conditions of licensing are:
a) the licensed activity in accordance with legal and regulatory framework;
b) ensuring that legal metrological control of measuring instruments used in health and public safety;
c) in a visible indication of commodity prices and tariffs for services in a form;
d) permit holding facilities, fire, environmental and occupational safety;
e) Availability of space with an ownership or rental for licensed activity;
f) Availability of specialists (engineers, bioengineering).
(3) The license statement for medical devices are attached the following additional documents:
a) copy of the deed or lease agreement will run the building where the licensed activity;
b) copies of documents confirming the right business studies, including areas required;
c) copies of documents confirming the continuous training and certification in areas required;
d) certificate of equivalence of the diploma obtained abroad, issued as provided, as appropriate.
Article 11. Suspension and revocation of license
(1) serve as grounds for license suspension:
a) violation of the requirements provided in art. 10;
b) lack of the property or expiration of the tenancy of the property where the licensed activity;
c) mismatch of the studies of persons employed with the types of activities performed;
d) non-normative acts in force in the field, including regulation / statute of organization and functioning of the institution.
(2) serve as grounds for license revocation:
a) conduct by the licensee to other matters than that specified in the license;
b) activity to another address than the one indicated in the license;
c) provide market and marketing of medical devices without documents of origin, certified, registered, marked accordingly;
d) engage in illegal activities of the licensee, seized by the authorities responsible for regulation and control;
e) the final decision of the court.
Article 12. Powers Agency
In medical devices, the Agency's main tasks are:
a) the criteria established by the Government on the designation and notification of conformity assessment bodies for medical devices, proposed to the Ministry of Health on the nomination list of notified bodies, whose technical competence is determined by the national accreditation body recommendations;
b) continuously monitor and estimate the activity of notified bodies, to withdraw the notification if they do not have adequate technical competence;
c) decide on the classification of a medical device if the dispute between the manufacturer and notified bodies;
d) authorize, in special cases (disasters, catastrophes, epidemics, epizootics, mass poisoning, in other cases that threaten human health, the absence of market substitutes or medical devices), making available on the market and putting into operation medical devices authorized in Moldova, but allowed the country of origin;
e) authorizes the program for the investigational procedure using medical devices intended for clinical investigation with the Commission for medical devices, may require the manufacturer or his authorized representative at the end of the investigation report;
f) participate in development programs in health care standards to harmonize standards with European directives for medical devices;
g) coordinates regulations and standards, except for national standards relating to medical devices;
h) aims that by reviewing the rules and regulations on medical devices to comply with harmonized European and international standards;
i) comply with international recommendations on medical devices occurred in other areas if these recommendations are within the regulated area;
j) coordinates the surveillance of medical devices;
k) to order provisional measures to withdraw the medical devices market if they produce incidents;
l) restrict or prohibit the right to use medical devices if they generate incidents;
m) prohibit the production and / or marketing of unregistered medical devices if they are made available on the market;
n) advising the activities of manufacturing, marketing, import, repair, testing and commissioning of medical devices in accordance with the conformity assessment procedures, to include natural persons and legal activities Register of medical devices;
a) registered in Moldova certified medical devices, medical devices CE marked, certified by notified bodies published in the Official Journal of the European Community or the accredited conformity assessment bodies which have concluded international recognition by recording register their devices;
p) provides certification of competence natural or legal persons responsible for making available on the market of medical devices, with their inclusion in the Register of authorized distributors of medical devices;
q) develop guidance on the conditions for obtaining advice and records to be approved by order of the Ministry of Health and published in the Official Gazette of the Republic of Moldova;
r) authorize the importation of medical devices;
s) perform other duties prescribed by law.
Article 13. Powers of assessment bodies
Notified bodies shall carry out conformity assessment of medical devices in accordance with the conformity assessment procedures in government decisions transposing European directives applicable to medical devices.
Chapter III - Classification of Medical Devices
Article 14. Classification of medical devices
(1) Medical devices are grouped into classes I, IIA, IIB and III, depending on the risks of use.
(2) criteria for the classification of medical devices are defined in the Annex to this Law.
Article 15. Conflicts of classification
In case of dispute between the manufacturer and the notified body responsible for conformity assessment on a medical device classification rules resulting from the application of the device, they are required to notify the Agency.
Chapter IV - The Free Movement of Medical Devices Certificates and the Intended Purposes Special
Article 16. CE MS
(1) Devices other than those ordered or intended for clinical investigation must bear the conformity mark SM the availability on the market.
(2) SM marking of conformity shall be affixed to the device or, where appropriate, its sterile packaging in a visible, legible and can not be deleted, and the manual. Where applicable, mark MS will be applied on the consumer packaging.
(3) shall be accompanied by the identification number of the notified body to assess compliance.
(4) The affixing of markings or inscriptions which are likely to mislead third parties regarding the meaning or the graphics of the mark MS. Any other marking may be affixed to the device, the packaging or instructions for the device, provided that it does not reduce visibility and legibility of marking MS.
Article 17. Devices for clinical investigations
Testing devices for clinical investigations carried out in accordance with regulations approved by the Government.
Article 18. Language information
(1) Information accompanying medical devices and are available to the user and / or the patient will be exposed to language or, where appropriate, international languages (English, Russian).
(2) records and correspondence relating to conformity assessment procedures shall be made mandatory in the state.
Chapter V - Standards of Medical Devices
Article 19. The essential
Essential requirements are those required medical devices specified in international standards and national ones.
Article 20. National standards related
List related national standards endorsed by a national standards body, approved by order of the Ministry of Health and published in the Official Gazette of the Republic of Moldova. List of national standards related to updates whenever necessary.
Chapter VI - Supervision Of Medical Devices
Article 21. Supervision of medical devices
(1) The purpose of surveillance of medical devices is to ensure that the manufacturer duly fulfills the obligations imposed by the approved quality system.
(2) The manufacturer must allow the notified body to carry out necessary inspections, putting at its disposal all relevant information, including:
a) quality system documentation;
b) the data stipulated in section design of the quality system, such as results of analyzes, calculations, tests, etc..;
c) the data stipulated in section manufacturing quality system, such as records of inspections and test data, calibration data, qualification reports of the personnel concerned, etc..
(3) medical device vigilance procedure is established by the Government.
Article 22. Incidents
(1) After an assessment of the incident by the body other than the one that has approved medical devices with the manufacturer, if possible, the Agency, together with the manufacturer or his authorized representative, shall take measures required by regulations normative.
(2) If incidents occur mismatch caused by medical devices to the essential requirements of the incorrect application of standards and the disparity between standards, the Agency will take appropriate action.
Article 23. CE incorrectly applied
If inadequate medical devices bearing the CE marking, the Agency is required to notify the Commission within 72 hours after discovery.
Article 24. Responsibility for monitoring
Responsible for supervising medical devices in use is users and aims to provide original quality, security and performance level as intended. In this regard, users are required:
a) to establish and implement a monitoring program of medical devices that takes into account risk, the use and complexity;
b) Make periodic review, maintenance and repair of medical devices;
c) communicate to producers and agency any incident during use;
d) Agency to report all medical devices available in the unit, recorded in the accounts as assets, regardless of how purchasing them.
Article 25. Actions under the supervision
(1) The Agency shall take measures to recall or ban the use of medical devices, under regulations approved by the Government.
(2) The measures specified in par. (1) shall immediately notify the interested party. It shall inform the Agency about possible remedies and the time limit required of such remedies.
Article 26. The manufacturer
(1) If the measures referred to in art. 25, the manufacturer or his authorized representative must be able to express their point of view, except that direct consultation is not possible because the measure must be taken urgently, and thus endangered the health and safety of patients and / or users.
(2) The manufacturer or, where appropriate, his authorized representative is required to provide service and spare parts for medical devices that provide the market for a period of 10 years.
Article 27. Notified body
The notified body shall inform the Agency about all certificates suspended or withdrawn and, on request, will provide all information according to Law. 422-XVI of 22 December 2006 on general product safety.
Chapter VII - Sanctions
Article 28. Liability
(1) Violation of this law will result in disciplinary, material, civil or, where appropriate, criminal under the law.
(2) For misdemeanors, the supervising agency may order the suspension of production and / or availability of medical devices market.
Article 29. The contraventions and fines
The contraventions and enforcement fines are agency staff and staff notified bodies appointed for that purpose.
Chapter VIII - Database
Article 30. State Register of devices medical
To track medical devices subject to conformity assessment, producers and suppliers of medical devices is established the State Register of medical devices under the law. Responsible for creating and managing the State Register of medical devices is the Ministry of Health.
For more information see the Health Care Legislation of Moldova