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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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Law 26,906

Traceability and verification of the technical fitness of the active medical products of health in use. Sanctioned: November 13, 2013 Enacted in Fact: December 6, 2013

The Senate and Chamber of Deputies of the Argentine Nation, meeting in Congress, etc., are sanctioned by law:


Chapter I

Purpose of the law, scope, definitions and scope of application

ARTICLE 1-Object. The purpose of this law is to establish the traceability regime for active medical products, the metrological traceability thereof, and the creation or strengthening of the Biomedical Technology Services throughout the national territory.

ARTICLE 2-Scope. This law includes all active medical products from public and private health facilities throughout the country.

ARTICLE 3-Definitions. For the purposes of this law, it is understood by: 1. Active medical product: Any medical device whose functioning depends on electrical energy or any source of power other than that generated by the human body or gravity and functioning by the conversion of this energy. Medical products intended to be transmitted, without causing any significant alteration, energy, substances or other elements of an active medical product to the patient shall not be considered as active medical products. 2. Traceability: A set of technical actions and procedures to identify and record each active medical product in use. 3. Metrological traceability: Property of the result of a measurement by which this result may be related to certain references, through an uninterrupted and documented chain of calibrations, each of which contributes to the certainty of the measure.

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4. Biomedical Technology Service: Encharged with the comprehensive management of the technological park of active medical products.

ARTICLE 4-Application Authority. The enforcement authority of this law shall be the Ministry of Health of the Nation.

Chapter II

Of the active medical products

ARTICLE 5-Types and classification of active medical products. The active medical products, which are the subject of this law, are grouped according to the intrinsic risk they represent for 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 active medical product and according to the rules laid down in the provision 2.318/2002, ordered text as available 1.285/2004, of the National Administration of Medicinal Products, Food and Medical Technology, ANMAT, or the one that in the future is dictated.

ARTICLE 6-Identification of active medical products. The implementing authority should define the identification mechanism, which permits the enabling, of the active medical products in use in the public and private health facilities of our country.

ARTICLE 7-Enabling active medical products. The health authorities shall extend the certificate of entitlement of the active medical products and their corresponding renewals, in accordance with the technical verification requirements to be determined.

ARTICLE 8-Warranty period. Excluded from the need for the corresponding technical verification for renewal, the equipment in the guarantee period whose manufacturers certify that their operating characteristics are insured during that period and corresponds to the instructions for use and maintenance, verification and regulation. Biomedical Technology Services can define the testing and testing of active medical products even within the warranty period.

Chapter III

Of the certificate of entitlement of active medical products

ARTICLE 9-Requirements. The certificate of entitlement must be granted on an individual basis to each active medical product, when tested in accordance with the applicable technical standards. The technical verification tests must be carried out on the spot by the Biomedical Technology Service of the health establishment, health region or jurisdiction. In the exclusive case of not having the necessary resources, the judicial authority must designate the form and means to carry it out. For this purpose, the laboratories accredited by the Argentine Accreditation Agency (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, can count on the laboratories.

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ARTICLE 10. -Effective. The judicial authority should define the duration of the certificates of entitlement for active medical products, according to their intrinsic health risk and in accordance with the provisions of Article 5 of this Law.

ARTICLE 11. -Renewal. It is a requirement for renewal that active medical products comply with the provisions laid down in Article 7 of this Law, as well as with the requirements to be determined by the implementing authority in a timely manner.

Chapter IV

Of the staff responsible for the medical products active in the health facilities

ARTICLE 12. -Registration. Surveillance. Health facilities should: (a) Create and keep up to date a record of active medical products in use; (b) Communicate the relevant health authority on any institutional or operational situation, related to the use of active medical products, which may involve a risk to patients, operators or third parties.

ARTICLE 13. -Responsible for the biomedical technology service. The Head of the Biomedical Technology Service should be a graduate and registered university professional, with responsibility in the field.

ARTICLE 14. -Personnel in charge of technical verification and maintenance of active medical products. The staff in charge of the technical verification, maintenance and repair services must demonstrate compliance with the training, training or update courses defined by the implementing authority.

ARTICLE 15. -Functions of the biomedical technology service. They are functions of the Biomedical Technology Service: (a) to intervene in the preparation of technical specifications and to advise on the acquisition of active medical products; b) Specify the requirements for supplies and physical resources necessary for the proper functioning of the products (c) Evaluate, select, accept, coordinate the implementation, maintain and maintain active medical products; (d) Train the operators of active medical products, as regards their correct use and risks (e) Dictate on the discharge and discharge of active medical products in use; advice on the installation, commissioning and maintenance of the services associated with the medical equipment and the optimal functioning of the medical equipment; (g) Establishing a method or procedure to keep the technical verification and maintenance of all active medical products, in which it intervenes.

Chapter V

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Of the implementing authority

ARTICLE 16. -Functions. They are functions of the implementing authority: a) Establish the identification mechanism for the traceability of active medical products and their measurements; b) Promote the creation or strengthening of the Biomedical Technology Services, in the entire territory of the Nation; creation of a Register of Services for Repairs and Maintenance of Active Medical Products, in conjunction with the jurisdictions; d) Establish the Good Operating Practices of the Reparation And Maintenance Services Active Medical Products; (f) Coordinate with the jurisdictional health authorities, the technical verifications of the active medical products in use, which it considers necessary; (g) Promote the creation of a National Register of Active Medical Products, in coordination with the jurisdictional authorities and according to the criteria established by provision 2.318/2002, text ordered according to provision 1.285/2004, of the National Administration of Medicines, Food and Medical Technology, ANMAT, or the one that in the future is dictated.

Chapter VI

Of the manufacturers and importers of medical health products

ARTICLE 17. -Tasks and responsibilities. In addition to those of their activity, manufacturers and importers of active medical products should: (a) Deliver complete, original and Spanish copies of the use and maintenance manuals and any additional information required by the implementing authority, the Biomedical Technology Services or the laboratories (b) To indicate the maintenance and control programmes which may correspond; (c) to incorporate, in each active medical product, the identification mechanism to be determined by the implementing authority for the purpose of enabling the traceability of the same.

Chapter VII

Of the service providers of repairs and maintenance of medical health products

ARTICLE 18. -Level of qualification. All service providers for the repair and maintenance of active medical products must have a technical officer, who must be an engineering professional with an enabling title for their exercise and registered, (i) with respect to the matter.

ARTICLE 19. -Registration and Enablement. The implementing authority, in coordination with the judicial authority, shall establish the time limit and the manner in which the Reparation And Maintenance Service Providers of the active medical products must be registered in the register. corresponding. The judicial health authority must check that the Reparation Service Providers and

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Maintenance of active medical products, comply with the requirements of good operating practice, as determined by the implementing authority.

ARTICLE 20. -Instrumental. The precise operating instruments used for specific tests must be backed up by documentary evidence of their current calibration carried out in a recognised body or through the certification of tests required by the manufacturers.

Chapter VIII


ARTICLE 21. -Failure to comply with this law will make it liable to its violators of the following sanctions: a) Receipt; b) Multa that must be updated by the national executive branch in annual form according to the official price index From the National Institute of Statistics and Censuses (INEC), from pesos ($1,000) to pesos, one hundred thousand ($100,000), which can be increased to the level in case of recidivism. These penalties shall be regulated in a gradual and cumulative manner taking into account the circumstances of the case, the nature and gravity of the infringement, the antecedents of the infringer and the injury caused, notwithstanding other civil and penalties to be taken. The production of the fines should be used, in agreement with the Federal Health Council (COFESA), to the financing of the established training courses and to actions of dissemination and awareness in accordance with the objectives of this law.

ARTICLE 22. -For cases of breaches of the law in public health establishments, the penalties should be applied only to the officials responsible in accordance with their own sanctioning regime for their function, without prejudice to the civil and criminal responsibilities to be taken.

ARTICLE 23. -The application of this law must establish the administrative procedure to be applied in its jurisdiction for the investigation of alleged infractions, ensuring the right of defence of the alleged infringer and other guarantees constitutional. The role established in this article should be coordinated with the national public bodies involved in the field of their areas covered by this law and with the jurisdictions. It may also delegate to the courts the substantiation of the proceedings to be taken against the infringements provided for and to give them representation in the proceedings of the judicial proceedings against the sanctions which apply. The administrative route will be exhausted directly before the Federal Court of Appeals with jurisdiction in administrative and administrative matters with jurisdiction at the place of the event. The resources to be brought against the application of the penalties provided for will have a positive effect. For justified reasons, in order to avoid an irreparable tax on the person concerned or in the case of third parties, the appeal may be granted with suspensory effect.

Chapter IX

Of accession

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ARTICLE 24. -Invite the provinces and Autonomous City of Buenos Aires to adhere to this law.

ARTICLE 25. -Contact the national executive branch.




Date of publication: 19/12/2013

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