Law No. 176 Of 18 October 2000 On Medical Devices

Original Language Title:  LEGE nr. 176 din 18 octombrie 2000 privind dispozitivele medicale

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Law No. 176 of 18 October 2000 (* republished *) (* updated *) concerning medical devices (updated until 2 July 2010 *)-PARLIAMENT ISSUING — — — — — — — — — — — — *) Text was republished law published in MONITORUL OFICIAL nr. 79 of 24 January 2005. This is the updated form of S.C. "territorial Center of Electronic Computing" Piatra Neamţ until July 2, 2010, with amendments and additions to law No.: 329 of 5 November 2009; EMERGENCY ORDINANCE No. 1 of 25 January 2010; EMERGENCY ORDINANCE No. 72 of 30 June 2010.
*) Republished under art. V of law No. 434/2004 on the amendment of law No. 176/2000 concerning medical devices, as published in the Official Gazette of Romania, part I, no. from 2 November 2004 1,009, posing a new texts.
Law No. 176/2000 concerning medical devices has been published in the Official Gazette of Romania, part I, no. 544 of 2 November 2000.
C.T.C.E. S.A.) Note Piatra Neamt: under the letter l) of art. 68, Cap. IX of law No. 329 of 5 November 2009 published in Official Gazette No. 761 of November 9, 2009, the date of entry into force of the decisions of the Government on the establishment, organization and functioning of the new entity resulting from the reorganisation of public authorities and institutions referred to in the appendices. 1 and 2 are repealed: first sentence of paragraphs 5 and 6). (2) of article 9. 6 of law No. 176/2000 concerning medical devices, republished in the Official Gazette of Romania, part I, no. 79 of 24 January 2005.
  

C.T.C.E. S.A.) Note Piatra Neamt: according to point 4 of article 2. The EMERGENCY ORDINANCE nr. 72 of 30 June 2010, published in MONITORUL OFICIAL nr. 452 of 2 July, 2010, throughout the law, the phrase "Medical Devices technical Office" shall be replaced by the phrase "national agency of Drug and medical devices".


Chapter I General provisions Article 1 (1) this Act establishes the legal and institutional framework for the control of medical devices, active implantable medical devices, medical devices for in vitro diagnosis, put into service and used, referred to as medical devices and for controlling the activities of marketing, distribution and provision of services in the field of medical devices.
  

(2) the provisions of this law shall apply to medical devices and accessories, when the accessories are used together with a device to allow its use for the purposes proposed. For the purposes of this law, the accessories are treated as medical devices.
  


Article 2 (1) the terms used in this law are defined in accordance with the provisions of art. 4 of law No. 608/2001 concerning the conformity assessment of products, with subsequent amendments and additions, and art.7. 2 of Government decision No. 190/2003 laying down 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 the placing on the market and/or putting into service of active implantable medical devices and of art. 2 of Government decision No. 798/2003 laying down the conditions for the placing on the market and use of medical devices for in vitro diagnosis.
  

(2) for the purposes of this law, the term in use is defined as the range of measures to ensure safety and confirmed in operation and performance, according to intended purpose, throughout the duration of operation of medical device incidents and identify themselves.
  


Article 3 (1) the activities of marketing, distribution and provision of services in the field of medical devices is carried out in compliance with the provisions of this law and applicable methodology approved by order of the Minister of health.
  

(2) the activities specified in paragraph 1. (1) are subject to control by an opinion. Exceptions to this requirement are doing activities that shall be performed by the manufacturer himself to medical devices subject to these activities.
  

(3) the notice referred to in paragraph 1. (2) is issued by the Ministry of Health, in compliance with the applicable methodology, based on the assessment of the competence and capability to natural or legal persons, as appropriate, to carry out the activities for which it is requesting the opinion.
  


Article 4 (1) medical devices marketed, distributed, to install and maintain, to be used according to their intended purpose, only by natural or legal persons in respect of which it has delivered its opinion; 3 paragraphs 1 and 2. 2. (2) the individuals and legal entities carrying out activities referred to in article 1. 3 paragraphs 1 and 2. (1) the bailiff and amending medical devices configuration times are considered as producers and are required prior to the implementation, operation and use of medical devices which have occurred, to submit to such medical devices conformity assessment according to requirements under the governmental decision nr. 190/2003, of the governmental decision nr. 798/2003 or of the governmental decision nr. 344/2004 as appropriate.
  


Article 5 medical devices are put into service and use is subject to the conditions laid down by the instructions approved by order of the Minister of health, the following ways: the periodic verification);
  

(b) after the repair or verification) change;
  

c-spot inspection and testing);
  

d) surveillance in use.
  


Article 6 (1) of the evaluation Activities referred to in article 1. 3 paragraphs 1 and 2. (3) as well as the control. 5 shall be carried out by the national agency of Drug and medical devices, referred to as ANMDM.
  

(2) ANMDM is set up as a result of the merger of the comasării through the national agency of Drug and Medical Devices technical Office.
  

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Art. 6 was amended by section 1 of article. The EMERGENCY ORDINANCE nr. 72 of 30 June 2010, published in MONITORUL OFICIAL nr. 452 of 2 July 2010.


Article 7 (1) in the application of the provisions of the present law, ANMDM has the following main tasks: — — — — — — — — — — — —-the introductory part of paragraph 1. (1) of article 1. 7 was amended by paragraph 2 of article 9. The EMERGENCY ORDINANCE nr. 72 of 30 June 2010, published in MONITORUL OFICIAL nr. 452 of 2 July 2010.

of specific technical procedures) develops in the field of medical devices that are approved by decision of the President of the ANMDM;
  

— — — — — — — — — — — —-a) of paragraph 1. (1) of article 1. 7 was amended by section 3 of article 9. The EMERGENCY ORDINANCE nr. 72 of 30 June 2010, published in MONITORUL OFICIAL nr. 452 of 2 July 2010.

b) evaluate and/or audit, at the request of the Ministry of health, the natural or legal person requesting the opinion referred to in article 1. 3 paragraphs 1 and 2. (3);
  

c) ensures, through examination and testing, inspection of medical devices, based on the methodology approved by order of the Minister of health;
  

d) ensure performance appraisal of medical devices, under the conditions provided for in this law;
  

e) inform the Health Ministry task force in conjunction with the results of the assessments/audits and controls carried out in accordance with the provisions of this law.
  

(2) ANMDM and other activities carried out under the law.
  

— — — — — — — — — — — —-. (2) of article 9. 7 was amended by paragraph 4 of art. The EMERGENCY ORDINANCE nr. 72 of 30 June 2010, published in MONITORUL OFICIAL nr. 452 of 2 July 2010 by replacing the phrase "Technical Office" medical devices "national agency of Drug and medical devices".


Article 8 medical devices used (second hand), and medical devices derived from donations are put into service and are only used in the assessment of their performance by ANMDM and based on the opinion issued by the Committee.
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Art. 8 was amended by paragraph 4 of art. The EMERGENCY ORDINANCE nr. 72 of 30 June 2010, published in MONITORUL OFICIAL nr. 452 of 2 July 2010 by replacing the phrase "Technical Office" medical devices "national agency of Drug and medical devices".


Chapter II, the authorities and bodies empowered to act in the field of medical devices in article 9 (1) the Ministry of health is the authority competent to take decisions in the field of medical devices.
  

(2) the Ministry of Health operates specialized structure that ensures achievement of its policy in the field of medical devices.
  


Article 10 Commission for medical devices is a body consisting of medical experts, appointed by order of the Minister of health. The Commission shall form part and one representative of producers and users, appointed by their associations.


Article 11 (1) medical devices Committee together with specialized structure referred to in art. 9 para. (2) the conduct of the clinical investigation on organizes human subjects of medical devices, in compliance with the regulations in force.
  

(2) the composition, organization and powers of the Committee on medical devices are approved by order of the Minister of health.
  


Chapter III Supervision of medical devices Article 12 individuals and legal entities that provide activities referred to in article 1. 3 paragraphs 1 and 2. (1) are required as these activities prior to provision, to seek the opinion referred to in article 1. 3 paragraphs 1 and 2. (3) and the Ministry of health to make known any change to the conditions which have led to the issuance of this opinion.


Article 13


(1) in order to ensure the level of safety and performance suitable for the purpose for which they are made and medical devices to avoid the generation of incidents, users are required to: (a) use) medical devices only for the purpose for which it was made;
  

b) to ensure that medical devices are used only during the period of validity of the licences, when necessary, and that does not show any deviations from the functional and performance requirements of safety;
  

c) to apply a programme of surveillance of medical devices, which take into account their risk for the patient, the use and complexity thereof, according to the methodology in force;
  

d) to ensure the periodic checking, maintenance and repair of medical devices;
  

e) to notify those manufacturers and the Ministry of health of any incident occurring during use;
  

f) to report to the Ministry of health in all existing medical devices unit, recorded in the accounts as assets, regardless of the manner of purchasing them, in accordance with the methodology approved by order of the Minister of health;
  

g) to provide a documented system of evidence concerning medical devices used, repaired and checked.
  

(2) an exception to the provisions of paragraph 1. (1) medical devices which are to be found at the user for clinical investigation or assessment of the performance and subject to the requirements of the regulations referred to in article 1. 11(2). (1) or, where appropriate, the conformity assessment procedure provided for in the applicable technical regulation.
  


Article 14 Users of medical devices must ensure that medical devices are put into service and used parts is ensured and that there are approved establishments for carrying out the service.


Chapter IV article 15 Sanctions violation this law shall entail disciplinary, material, administrative, civil or criminal, as appropriate, in accordance with the law.


In article 16, the following acts shall constitute offences and shall be imposed as follows: non-compliance with the provisions of article) "". (1) with fine 25,000,000 lei la 50,000,000 lei, applicable to the service provider's activity and unauthorized users, as well as cancellation of the right to request the opinion referred to in article 1. 3 paragraphs 1 and 2. (2);
  

(b) failure to meet the requirements of article.) "". (2) with fine 50,000,000 lei lei, the withdrawal of approval 100,000,000; 3 paragraphs 1 and 2. (2) and the right to ask for more this opinion;
  

(c) failure to comply with the provisions of article 1.) 8, with fine 25,000,000 lei la 50,000,000 lei and the prohibition of the use of the medical device until the date of obtaining the opinion referred to in this law;
  

d failure to comply with the provisions of article 1.) 12, with fine 25,000,000 lei la 50,000,000 lei;
  

failure to comply with the provisions of article e). 13(2). (1) (a). a)-(e)), with fine 25,000,000 lei la 50,000,000 lei;
  

f) to prevent any form of persons authorized to exercise the powers provided for in the present law on the control of medical devices, with fine 25,000,000 lei la 50,000,000 lei.
  


Article 17 the finding of violations and imposition of fines are administrative staff ANMDM, empowered for this purpose.
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Art. 17 was amended by paragraph 4 of art. The EMERGENCY ORDINANCE nr. 72 of 30 June 2010, published in MONITORUL OFICIAL nr. 452 of 2 July 2010 by replacing the phrase "Technical Office" medical devices "national agency of Drug and medical devices".


Article 18 (1) Against the minutes in respect of contraventions can be made a legal complaint by the person or the natural person, within 15 days from the date of its communication, the District Court in whose territorial RADIUS was committed that offence.
  

(2) judgment of the Court is subject to appeal as provided by law.
  


Article 19 the provisions concerning liability referred to in this law, contravention shall be supplemented by those of the Government Ordinance. 2/2001 on the legal regime of contraventions, approved with amendments and completions by law No. 180/2002, as amended.


Chapter V, article 20 database data recorded in accordance with this law shall be stored in a database, organized and coordinated by the Ministry of health.


Article 21 detailed rules and instructions approved by order of the Minister of health in accordance with the provisions of this law shall be published in the Official Gazette of Romania, part I.


Chapter VI transitional and final Provisions Article 22 (1) for the issuance under article 13. 12 the Health Ministry charged of 3,000,000 lei.
  

(2) the amount referred to in paragraph 1. (1) may be amended by decision of the Government regularly.
  

(3) For the examinations referred to in article 1. 7 para. (1) (a). b)-d) ANMDM fixes and amount of the Services receives fixed-based tariffs.
  

— — — — — — — — — — — —-. (3) art. 22 was amended by paragraph 4 of art. The EMERGENCY ORDINANCE nr. 72 of 30 June 2010, published in MONITORUL OFICIAL nr. 452 of 2 July 2010 by replacing the phrase "Technical Office" medical devices "national agency of Drug and medical devices".

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Art. 23 was repealed by the letter i) art. 14 of the EMERGENCY ORDINANCE nr. 1 of 25 January 2010, published in MONITORUL OFICIAL nr. 62 from 27 January 2010.


Article 24 Staff ANMDM, empowered to exercise the activities referred to in article 1. 7 para. (1) (a). b)-d), has a right of access in all locations where they are put into service and use of medical devices, as well as in places where the activities referred to in article 1. 3 paragraphs 1 and 2. (1).
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Art. 24 was amended by paragraph 4 of art. The EMERGENCY ORDINANCE nr. 72 of 30 June 2010, published in MONITORUL OFICIAL nr. 452 of 2 July 2010 by replacing the phrase "Technical Office" medical devices "national agency of Drug and medical devices".


Article 25 legal entities and natural persons involved in the application of the provisions of this Act are required to ensure the confidentiality of information obtained in carrying out their duties. This does not affect any obligation with respect to providing information, in the 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 detailed rules for its application.


Note: the article below is below. III and IV of law No. 434/2004 on the amendment of law No. 176/2000 concerning medical devices, which are not incorporated in the consolidated text of the law No. 176/2000: " III.-the rules of organization and functioning of the Office of Technical medical devices are approved by decision of the Government, within 30 days after the entry into force of this law.
Art. IV.-this law shall enter into force on 1 January 2005. ' — — — — — — — — — — — — — —