System Of Traceability And Verification Of The Technical Fitness Of Active Medical Use Health Products.

Original Language Title: Régimen de trazabilidad y verificación de aptitud técnica de los productos médicos activos de salud en uso.

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PRODUCTS medical products medical law 26.906 regime of traceability and verification of the technical fitness of active medical use health products. Sanctioned: 13 November 2013 fact promulgated: 6 December 2013 the Senate and Chamber of deputies of the Argentina nation gathered in Congress, etc. they attest to the force of law: regime of traceability and verification of fitness technique of LOS products medical assets of health in use chapter I object of law, reach, scope and definitions article 1 - object. The present law has by object establish the regime of traceability of the products medical active, it traceability metrological of them same, and the creation or strengthening of them services of technology biomedical in all the territory national.
Article 2º - scope. This law includes all active medical devices from the establishments of health, public and private, throughout the national territory.
Article 3º - definitions. For the purposes of this law: 1. active medical product: any medicinal product whose operation depends on electrical energy or any source of power other than that generated by the human body or gravity and which works by converting this energy. Active medical devices, medical devices intended to transmit, without causing significant alteration any, energy, substances or other elements of an active medical product to the patient shall not be considered. 2. traceability: set of actions and procedures technical that allow identify and register each product physician active in use. 3. metrological traceability: property of the result of a measurement by which that result can be documented and related to certain references, through an unbroken chain of calibrations, each of which contributes to the certainty of the measure. 4. Service of technology biomedical: responsible of managing in form integral the park technology of products medical active.
Article 4. - implementing authority. The authority of application of the present law shall be the Ministry of health of the nation.
Active medical devices, chapter II article 5 - types and classification of active medical devices. Products medical assets, subject to this law, are grouped according to the intrinsic risk posed to the health of the consumer, patient, operator or third parties involved in classes I, II, III or IV. They are classified according to the purpose of each medical device active and according to the rules laid down in the provision 2.318/2002, orderly text according to 1.285/2004, of the national administration of drugs, foods and medical technology, ANMAT, or which in the future will dictate.
Article 6º - identification of active medical devices. The enforcement authority must define the identification mechanism, that allows enabling, active medical devices used in health facilities, public and deprived of our country.
Article 7th - enabling active medical devices. Them authorities health jurisdictional, must extend the certified of enabling of them products medical active and their corresponding renovations, according to the requirements of verification technical that is determined.
Article 8º - warranty period. They are excluded from the need of corresponding technical verification for renewal, equipment in warranty period whose manufacturers certify that their operating characteristics are insured during that period and corresponds to them according to the instructions of use and maintenance, verification and regulations. Biomedical technology services can set the realization of tests and inspections of active medical devices still within the warranty period.
Chapter III of the certificate of qualification of active medical devices article 9º - requirements. Enabling certificate should give individually to each active medical product, when it is tested according to the applicable technical standards. Technical verification tests must be done on-site by the service of biomedical technology for the establishment of health, health region or jurisdiction. In the unique case of not having the necessary resources, the jurisdictional authority must designate the form and means for this purpose. For this purpose you can count on the laboratories accredited by the Argentine accreditation organism (O.A.A), the National Institute of Industrial Technology (I.N.T.I.) or laboratories associated with the I.N.T.I., or laboratories of public universities. article 10. -Entry into force. The judicial authority must define the duration of certificates of qualification of active medical devices, according to their intrinsic risk to health, and pursuant to article 5 of this law.
ARTICLE 11. -Renewal. It is a requirement for renewal, that active medical devices comply with the provisions laid down in article 7 of this law, as thus also with the requirements determined by the enforcement authority promptly.
Chapter IV of the staff responsible for active medical devices in article 12 health facilities. -Registry. Surveillance. Health facilities must be: to) create and maintain updated a register of active medical devices in use; (b) communicate to the appropriate health authority about any institutional or operational situation related to the use of active medical devices, that it may involve risk to patients, operators or third parties.
ARTICLE 13. -Responsible for the service of biomedical technology. Responsible for the service of biomedical technology must be a University professional degree and enrolled, with competence in the matter.
ARTICLE 14. -Staff in charge of the technical verification and maintenance of active medical devices. The staff in charge of technical verification, maintenance and repair services must evidence compliance with the courses of training, training, or update that defines the enforcement authority.
ARTICLE 15. -Biomedical technology service functions. The functions of technology biomedical service are: to) participate in the preparation of technical specifications and advise for the acquisition of active medical devices; (b) specify the requirements of supplies and resources physical necessary for the correct operation of the products medical active; (c) assess, select, accept, coordinate the implementation underway, keep and keep them products medical active; (d) train to the operators of them products medical active, in what respect to their correct use and to them risks associated; (e) decide on the high and low of the products medical assets in use; (f) provide advice in what respect to the installation, put up and maintenance of them services associated to the equipment medical and the optimal operation of them themselves; (g) establish a method or procedure to maintain documented the verification technical and maintenance of all those products medical active, in which intervene.
Chapter V of the authority of application article 16. -Features. The functions of the enforcement authority are: to) establish the mechanism identification for traceability of active medical devices and their measurements; b) promote the establishment or strengthening of technology Biomedical services, throughout the territory of the nation; (c) to promote the creation of a registry of services of repair and maintenance of products medical assets, in conjunction with the jurisdictions; (d)) establish the good practices of operation of providers of services repairs and maintenance of products medical assets; f) coordinate with the jurisdictional health authorities, scrutineering of active medical devices in use, which deems necessary; (g) to promote the creation of a national registry of products medical assets, in coordination with the judicial authorities and according to the criteria established by the provision 2.318/2002, text ordered according to available 1.285/2004, of the national administration of drugs, foods and medical technology, ANMAT, or which in the future will dictate.
Chapter VI of the manufacturers and importers of medical products of health article 17. -Tasks and responsibilities. (Besides those own of its activity, them manufacturers and importers of of them products medical active must: to) deliver copies complete, original and in language Spanish, of them Manual of use and maintenance, and of all information complementary, that you are required by the authority of application, them services of technology biomedical or them laboratories mentioned in the article 9 °; (b) indicate the program of maintenance and control that could correspond; (c) incorporate, in each product medical active, the mechanism of identification that determine the authority of application, to the effects of allow the traceability of them themselves.
Chapter VII of the providers of services of repairs and maintenance of the products medical of health

ARTICLE 18. -Level of qualification. All them health providers of them services of repairs and maintenance of them products medical active must count with a responsible technical, which must be a professional of the engineering with title enabling for their exercise and enrolled, with incumbency in the matter.
ARTICLE 19. -Registration and authorization. The authority of application, in coordination with the authority jurisdictional shall establish the term and the form, in that them health providers of services of repairs and maintenance of them products medical active, must sign is in the record corresponding. Jurisdictional health authority must check that the providers of repair and maintenance of active medical devices, comply with the requirements of good practices in operation, to be determined by the enforcement authority.
ARTICLE 20. -Instrumental. Instruments for precise operation that is used in specific tests must have documentary support from its existing calibration approved body or through certification tests required by the manufacturer.
Chapter VIII penalties article 21. (-Non-compliance with the provisions of the present law will be liable to their offenders of the following sanctions: a) a warning; (b) fine that must be updated by the national executive power on a yearly basis in accordance with the price index official of the National Institute of statistics and censuses - INDEC-, since mil pesos ($ 1,000) to one hundred thousand pesos ($ 100,000), likely to be increased up to tenfold in the case of recidivism. These sanctions shall be governed in gradual and cumulative to taking into account the circumstances of the case, the nature and gravity of the offence, the antecedents of the offender and the damage caused, however other civil and criminal liability to any place. The proceeds of fines are must be, in agreement with the Federal Council's health - COFESA-, to the financing of training courses established and actions of dissemination and awareness-raising as to the objectives of this Act.
ARTICLE 22. -For cases of non-compliance to the law in public health facilities, the sanctions should be applied only to the responsible officials under the own punitive regime that corresponds to them by their function, without prejudice to the civil and criminal responsibilities to any place.
ARTICLE 23. -The authority for the application of this Act must set the administrative procedure to apply in your jurisdiction for the investigation of alleged violations, ensuring the right to defence of the alleged infringer and other constitutional guarantees. Established in this article function should coordinate it with national public bodies involved in the field of the areas covered by this law and jurisdictions. You can also delegate the conduct of the procedures that provided for infringements give rise to jurisdictions and give them their representation in the processing of judicial remedies that will stand against the sanctions that apply. Exhausted administrative remedies shall be resource Court directly to the Federal Chamber of appeal with competence in contentious-administrative courts with jurisdiction in the place of the fact. The resources that will stand against the application of the penalties provided for shall have devolutive effect. Reasons well-founded, aimed at avoiding an irreparable damage assessment to the person concerned or in receipt of third parties, the resource may be granted with suspensive effect.
Chapter IX accession article 24 -Invited the provinces and the autonomous city of Buenos Aires to adhere to this law.
ARTICLE 25. -Communicate to the national executive power.

Date of publication: 19/12/2013