LEGE no. 176 176 of 18 October 2000 (** republished) (* updated *) on medical devices ((updated until 2 July 2010 *)
ISSUER
PARLIAMENT
--------------- *) The republished text of the law was published in the OFFICIAL GAZETTE no. 79 79 of 24 January 2005. This is the updated form of S.C. "Territorial Center of Electronic Computing" S.A. Piatra-Neamt until July 2, 2010, with the amendments and additions made by: LAW no. 329 329 of 5 November 2009 ; EMERGENCY ORDINANCE no. 1 1 of 25 January 2010 ; EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 . ** **) Republicated pursuant to art. V of Law no. 434/2004 for amendment Law no. 176/2000 on medical devices, published in the Official Gazette of Romania, Part I, no. 1.009 of 2 November 2004, giving the texts a new numbering. Law no. 176/2000 on medical devices was published in the Official Gazette of Romania, Part I, no. 544 544 of 2 November 2000. ***) NOTE C.T.C.E. S.A. Piatra-Neamt: According to letter l) art. 68, Cap. IX of LAW no. 329 329 of 5 November 2009 , published in MONITORUL OFFICIAL no. 761 of 9 November 2009, on the date of entry into force of the Government's decisions on the establishment, organization and functioning of the new entities resulting from the reorganization of public authorities and institutions provided for in Annexes 1 1 and 2 shall be repealed: l) first sentence of par. ((2) art. 6 6 of Law no. 176/2000 on medical devices, republished in the Official Gazette of Romania, Part I, no. 79 79 of 24 January 2005. ... ****) NOTE C.T.C.E. S.A. Piatra-Neamt: According to 4 4 of art. II of EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 , published in MONITORUL OFFICIAL no. 452 of July 2, 2010, throughout the law, the phrase "Technical Office of Medical Devices" is replaced by the phrase "National Agency of Medicines and Medical Devices". + Chapter I General provisions + Article 1 (1) The present law establishes the legal and institutional framework for the control of medical devices, active implantable medical devices, in vitro diagnostic medical devices, put into operation and used, hereinafter referred to as medical devices, as well as for the control of marketing, distribution and service activities in the field of medical devices. ... (2) The provisions of this law also apply to the accessories of medical devices, when accessories are used together with a medical device to allow its use for the intended purpose. For the purposes of this law, accessories are treated as medical devices. ... + Article 2 (1) The terms used in this Law are defined according to art. 4 4 of Law no. 608/2001 on the conformity assessment of products, with subsequent amendments and completions, and according to art. 2 of Government Decision no. 190/2003 laying down the conditions for the placing on the market and use of medical devices, of art. 2 of Government Decision no. 344/2004 laying down the conditions for placing on the market and/or putting into service active implantable medical devices and of art. 2 of Government Decision no. 798/2003 laying down the conditions for placing on the market and use of medical devices for in vitro diagnosis. ... (2) For the purposes of this Law, the term supervision in use is defined as the set of measures to ensure and confirm the functional safety and performance, according to the intended purpose, for the duration of operation of the the medical device and identify the incidents in use. ... + Article 3 (1) The marketing, distribution and service activities in the field of medical devices shall be carried out in compliance with the provisions of this law and the applicable methodological norms, approved by order of the Minister of Health. ... (2) The activities provided in par. ((1) shall be controlled by endorsement. Exception to this requirement are the activities that are carried out by the manufacturer of the medical devices that are the subject of these activities. ... (3) The opinion provided in par. (2) is issued by the Ministry of Health, in compliance with the applicable methodological norms, based on the assessment of the competence and capability of natural or legal persons, as the case may be, to carry out the activities for which it ... + Article 4 (1) Medical devices shall be sold, distributed, installed and maintained, in order to be used in accordance with the intended purpose, only by natural or legal persons for whom the opinion provided in art. 3 3 para. ((2). ... (2) The natural and legal persons who carry out the activities provided in art. 3 3 para. ((1) and which modify the functional parameters or the configuration of medical devices are considered manufacturers and are obliged, prior to the commissioning and use of medical devices on which they have intervened, to submit these medical devices conformity assessment, according to the requirements Government Decision no. 190/2003 ,, of Government Decision no. 798/2003 or ale Government Decision no. 344/2004 ,, as appropriate. ... + Article 5 Medical devices put into service and in use shall be subject, under the conditions established by the instructions approved by order of the Minister of Health, to the following ways of control: a) periodic verification; ... b) verification after repair or modification; ... c) unannounced inspection and testing; ... d) surveillance in use. ... + Article 6 (1) The evaluation activities referred to in art. 3 3 para. (3), as well as the control ones provided for in art. 5 is carried out by the National Agency of Medicines and Medical Devices, hereinafter referred to as ANMDM. ... (2) ANMDM is established as a result of merger merger of the National Medicines Agency and the Technical Office of Medical Devices. ... ------------- Article 6 has been amended by section 6. 1 1 of art. II of EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 , published in MONITORUL OFFICIAL no. 452 452 of 2 July 2010. + Article 7 (1) In application of the provisions of this Law, ANMDM has the following main tasks ... ------------- The introductory part of para. ((1) of art. 7 7 has been amended by section 4.2 2 2 of art. II of EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 , published in MONITORUL OFFICIAL no. 452 452 of 2 July 2010. a) develop specific technical procedures in the field of medical devices, which are approved by decision of the President of ANMDM; ... ------------- Letter a) a par. ((1) of art. 7 7 has been amended by section 4.2 3 3 of art. II of EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 , published in MONITORUL OFFICIAL no. 452 452 of 2 July 2010. b) assess and/or audit, at the request of the Ministry of Health, the natural or legal persons who request the opinion provided in art. 3 3 para. ((3); ... c) ensure, through examination and testing, the control of medical devices, based on the methodological norms approved by order of the Minister of Health; ... d) ensure the evaluation of the performance of medical devices, under the conditions provided for by ... e) inform the Ministry of Health operatively about the results of the assessments/audits and controls carried out according to the provisions of the ... (2) ANMDM carries out other activities, under the law. ... ------------- Alin. ((2) of art. 7 7 has been amended by section 4 4 of art. II of EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 , published in MONITORUL OFFICIAL no. 452 of July 2, 2010, by replacing the phrase "Technical Office of Medical Devices" with the phrase "National Agency of Medicines and Medical Devices". + Article 8 Second hand medical devices (second hand), as well as medical devices from donations are put into operation and are used only after the evaluation of their performance by ANMDM and on the basis of the opinion issued by it. ------------- Article 8 has been amended by section 6.6. 4 4 of art. II of EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 , published in MONITORUL OFFICIAL no. 452 of July 2, 2010, by replacing the phrase "Technical Office of Medical Devices" with the phrase "National Agency of Medicines and Medical Devices". + Chapter II Authorities and bodies empowered in the field of medical devices + Article 9 (1) The Ministry of Health is the competent and decision-making authority in medical devices. ... (2) The Ministry of Health operates the specialized structure that ensures its policy in the field of medical devices. ... + Article 10 The Medical Device Commission is a body made up of experts on medical fields, appointed by order of the Minister of Health. The commission also includes a representative of producers and users, designated by their associations. + Article 11 (1) The Commission for medical devices together with the specialized structure provided for in art. 9 9 para. (2) organize the conduct of clinical investigation on human subjects of medical devices, according to the regulations in force. ... (2) The composition, organization and duties of the Commission for medical devices are approved by order of the Minister of Health. ... + Chapter III Medical device surveillance + Article 12 Individuals and legal entities providing the activities referred to in art. 3 3 para. (1) are obliged, prior to the provision of these activities, to request the opinion provided for in art. 3 3 para. ((3) and to make known to the Ministry of Health any change to the conditions underlying the issuance of this opinion. + Article 13 ((1) In order to ensure the level of security and performance appropriate to the purpose for which medical devices are carried out and to avoid the generation of incidents, users shall: ... a) to use medical devices only for the purpose for which they were made; ... b) to ensure that medical devices are used only during their period of validity, when applicable, and that they do not show deviations from the functional performance and the applicable security requirements; ... c) to apply a program of supervision of medical devices, taking into account their risk to the patient, the field of use and their complexity, according to the methodological norms in force; ... d) to ensure regular checking, maintenance and repair of medical devices; ... e) to communicate to the producers and the Ministry of Health any incident occurred during use; ... f) to report to the Ministry of Health all medical devices existing in the unit, registered in the accounting records as fixed assets, regardless of how to purchase them, according to the methodological norms approved by order of the Minister health; ... g) to ensure a documented system of records on the medical devices used, repaired and verified. ... (2) Exception to the provisions of par. (1) make medical devices that are found in the user for clinical investigation or performance evaluation for certification and subject to the requirements of the regulations provided in art. 11 11 para. ((1) or, where appropriate, the conformity assessment procedure laid down in the applicable technical regulation. ... + Article 14 Users of medical devices must ensure that for medical devices put into operation and used, spare parts are provided and that there are approved units for performing service. + Chapter IV Sanctions + Article 15 Violation of the provisions of this law attracts disciplinary, material, civil, contravention or criminal liability, as appropriate, according to the law. + Article 16 It constitutes contraventions the following facts and is sanctioned as follows: a) non-compliance with 4 4 para. (1), with a fine of 25,000,000 lei to 50,000,000 lei, applicable to users and the provider of the non-approved activity, as well as the cancellation of the right to request the opinion provided in art. 3 3 para. ((2); ... b) non-compliance with 4 4 para. (2), with a fine of 50,000,000 lei to 100,000,000 lei, the withdrawal of the opinion provided in art. 3 3 para. (2) and the right to request such an opinion; ... c) non-compliance with 8, with a fine of 25,000,000 lei to 50,000,000 lei and prohibition of the use of the medical device until the date of obtaining the opinion provided by this law; ... d) non-compliance with 12, with a fine of 25,000,000 lei to 50,000,000 lei; ... e) non-compliance with 13 13 para. ((1) lit. a)-e), with a fine of 25,000,000 lei to 50,000,000 lei; ... f) preventing in any form the persons empowered to exercise the powers provided for in this law on the control of medical devices, with a fine from 25,000,000 lei to 50,000,000 lei. ... + Article 17 The finding of contraventions and the application of contravention fines shall be made by ANMDM personnel, empowered for this purpose. ------------- Article 17 has been amended by section 6.6. 4 4 of art. II of EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 , published in MONITORUL OFFICIAL no. 452 of July 2, 2010, by replacing the phrase "Technical Office of Medical Devices" with the phrase "National Agency of Medicines and Medical Devices". + Article 18 (1) Against the minutes of finding the contraventions can be made a complaint by the legal person or the individual, within 15 days from the date of its communication, at the court in whose territorial area was committed Contravention. ... (2) The judgment delivered by the court is subject to the remedies provided by law. ... + Article 19 The provisions on the contravention liability provided for by this Law shall be completed with those of Government Ordinance no. 2/2001 on the legal regime of contraventions, approved with amendments and additions by Law no. 180/2002 ,, as amended. + Chapter V Database of data + Article 20 The data recorded in accordance with this law will be stored in a database organized and coordinated by the Ministry of Health. + Article 21 The methodological norms and instructions approved by order of the Minister of Health according to the provisions of this Law shall be published in the Official Gazette of Romania + Chapter VI Transitional and final provisions + Article 22 (1) For the issuance of the opinion provided for in 12 The Ministry of Health charges a fee of 3,000,000 lei. ... (2) The amount of the amount provided in par. (1) may be amended periodically by Government decision. ... (3) For the examinations provided for in art. 7 7 para. ((1) lit. b)-d) ANMDM establishes and collects the value of the services fixed on the basis of tariffs. ... ------------- Alin. ((3) of art. 22 22 has been amended by section 4 4 of art. II of EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 , published in MONITORUL OFFICIAL no. 452 of July 2, 2010, by replacing the phrase "Technical Office of Medical Devices" with the phrase "National Agency of Medicines and Medical Devices". ------------- Article 23 was repealed by letter i) art. 14 of EMERGENCY ORDINANCE no. 1 1 of 25 January 2010 , published in MONITORUL OFFICIAL no. 62 62 of 27 January 2010. + Article 24 ANMDM staff, empowered to exercise the activities provided in art. 7 7 para. ((1) lit. b)-d), has the right of access to all locations where medical devices are put into operation and use, as well as in the places where the activities referred to in art. 3 3 para. ((1). ------------- Article 24 has been amended by section 4.2. 4 4 of art. II of EMERGENCY ORDINANCE no. 72 72 of 30 June 2010 , published in MONITORUL OFFICIAL no. 452 of July 2, 2010, by replacing the phrase "Technical Office of Medical Devices" with the phrase "National Agency of Medicines and Medical Devices". + Article 25 Legal entities and individuals involved in the application of the provisions of this law are obliged to ensure confidentiality regarding the information obtained in the performance of their duties. It does not affect the obligation with regard to the provision of information, in cases covered by criminal law. + Article 26 The Ministry of Health will develop within 3 months from the date of entry into force of this law the methodological norms for its application. + NOTE: We reproduce below the provisions art. III and IV of Law no. 434/2004 for amendment Law no. 176/2000 on medical devices, which are not incorporated in the republished text of the Law no. 176/2000 : "" Art. III. -The organization and functioning regulation of the Technical Office of Medical Devices is approved by Government decision, within 30 days from the entry into force of this law. Art. IV. -This law shall enter into force on 1 January 2005. ' --------------
