Medical Products Regimen Of Traceability And Verification Of Technical Aptitude - Full Text Of The Norm

Original Language Title: PRODUCTOS MEDICOS REGIMEN DE TRAZABILIDAD Y VERIFICACION DE APTITUD TECNICA - Texto completo de la norma

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MEDICAL PRODUCTS

Law 26.906

Traceability and verification of technical aptitude of active medical products in use.

Sanctioned: November 13 of 2013

Cast: December 6, 2013

The Senate and Chamber of Deputies of the Argentine Nation assembled in Congress, etc. sanction with force

Law:

REGIME OF TRAZABILITY AND VERIFICATION OF TECHNICAL APTITY OF ACTIVE MEASURES OF HEALTH IN US

Chapter I

Law, scope, definitions and scope of application

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

ARTICLE 2 — Scope. This Act includes all active medical products from public and private health facilities throughout the national territory.

ARTICLE 3o — Definitions. For the purposes of this Act, it is understood that:

1. Active medical product: Any medical product whose operation depends on electrical energy or any power source other than that generated by the human body or gravity and which works by converting this energy. No active medical products shall be considered, medical products intended to transmit, without causing any significant alteration, energy, substances or other elements of an active medical product to the patient.

2. Traceability: Set of technical actions and procedures that allow the identification and registration of each active medical product in use.

3. Metrological Traceability: Property of the result of a measurement by which that 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.

4. Biomedical technology service: In charge of comprehensive management of the active medical technology park.

ARTICLE 4o — Implementing authority. The authority to implement this law shall be the Ministry of Health of the Nation.

Chapter II

From active medical products

ARTICLE 5o — Types and classification of active medical products. Active medical products, subject to 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, which is ordered according to the provision 1.285/2004, of the National Administration of Medicines, Food and Medical Technology, ANMAT, or which is dictated in the future.

ARTICLE 6o — Identification of active medical products. The application authority must define the identification mechanism, which allows the empowerment, of active medical products in use in public and private health facilities in our country.

ARTICLE 7o — Enabling active medical products. Jurisdictional health authorities should extend the certificate of qualification of active medical products and their corresponding renewals, in accordance with the technical verification requirements to be determined.

ARTICLE 8o — Warranty period. They are excluded from the need for the corresponding technical verification for renewal, the equipment in warranty period whose manufacturers certify that their operating characteristics are ensured during such period and correspond to them according to the instructions of use and maintenance, verification and regulation.

Biomedical Technology Services can define testing and verification of active medical products even if it is within the warranty period.

Chapter III

From Certificate of Enabling Active Medical Products

ARTICLE 9o — Requirements. The certificate of qualification should be granted individually to each active medical product, when tested according to applicable technical standards.

Technical verification tests should be conducted on-site by the Biomedical Technology Service of the establishment of health, health region or jurisdiction. In the exclusive case of not having the necessary resources, the jurisdictional authority must designate the form and means to perform it. To this end, 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 I.N.T.I., or public universities laboratories may be available.

ARTICLE 10. - Watch. The jurisdictional authority must define the duration of the certificates of the qualification of active medical products, according to their intrinsic risk for health and in accordance with Article 5 of this Law.

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

Chapter IV

Staff responsible for active medical products in health facilities

ARTICLE 12. - Registration. Surveillance. Health facilities should:

(a) Creating and maintaining updated a register 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 risk to patients, operators or third parties.

ARTICLE 13. - Responsible for the service of biomedical technology. The head of the Biomedical Technology Service must be a graduate and registered university professional, with responsibility for this.

ARTICLE 14. - Staff in charge of technical verification and maintenance of active medical products. Staff in charge of technical verification, maintenance and repair services must demonstrate compliance with training, training or updating courses that define the application authority.

ARTICLE 15. - Functions of the biomedical technology service. These are functions of the Biomedical Technology Service:

(a) To intervene in the development of technical specifications and to advise on the acquisition of active medical products;

(b) Specify the requirements of supplies and physical resources necessary for the proper functioning of active medical products;

(c) Assess, select, accept, coordinate, maintain and retain active medical products;

(d) Train operators of active medical products with regard to their correct use and associated risks;

(e) Dictamine the high and low levels of active medical products in use;

(f) To provide advice on the installation, implementation and maintenance of medical equipment services and the optimal functioning of medical equipment;

(g) Establish a method or procedure to keep documented the technical verification and maintenance of all active medical products, in which it intervenes.

Chapter V

Implementation authority

ARTICLE 16. - Functions. These 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 throughout the territory of the Nation;

(c) Promote the establishment of a Register of Repairs and Maintenance of Active Medical Products, in conjunction with jurisdictions;

(d) Establishing the Best Practices for the Functioning of Reparations and Maintenance of Active Medical Products Providers;

(f) Coordinate with the jurisdictional health authorities, the technical verifications of active medical products in use, as deemed necessary;

(g) Promote the creation of a National Register of Asset Medical Products, in coordination with the jurisdictional authorities and according to the criteria established by provision 2,318/2002, which is ordained according to provision 1,285/2004, of the National Administration of Medicines, Food and Medical Technology, ANMAT, or which in the future is given.

Chapter VI

From 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) To provide full, original and Spanish-language copies of the use and maintenance manuals and any additional information required by the application authority, the Biomedical Technology Services or the laboratories referred to in Article 9;

(b) Indicate the appropriate maintenance and control programmes;

(c) Incorporate, in each active medical product, the identification mechanism to be determined by the application authority for the purpose of enabling the traceability of the same.

Chapter VII

Reparation and maintenance of medical products

ARTICLE 18. - Qualification level. All service providers of repairs and maintenance of active medical products must have a technical responsibility, which must be an engineering professional with an enabling degree for their exercise and enrollment, with responsibility for the matter.

ARTICLE 19. - Registration and empowerment. The enforcement authority, in coordination with the jurisdictional authority, shall establish the time and manner in which the Repair and Maintenance Services Providers of active medical products must register in the relevant registry.

The jurisdictional health authority must ensure that the Reparations and Maintenance Services of active medical products comply with the requirements of good operating practices, as determined by the enforcement authority.

ARTICLE 20. - Instrumental. The precise operating instruments used in specific tests must have the documentary backing of their current calibration performed by recognized organism or by the proof certifications required by the manufacturers.

Chapter VIII

Sanctions

ARTICLE 21. - Failure to comply with the provisions of this Act will make its perpetrators liable to the following penalties:

(a) Perception;

(b) A fine that must be updated by the national executive branch on an annual basis according to the official price index of the National Institute of Statistics and Censuses (INDEC), from pesos a thousand ($ 1,000) to pesos a hundred thousand ($ 100,000), capable of being increased to the decuplo in case of recidivism.

These sanctions shall be regulated in a gradual and cumulative manner, taking into account the circumstances of the case, the nature and gravity of the offence, the background of the offender and the injury caused, notwithstanding other civil and criminal responsibilities to which there is room.

The production of the fines should be allocated, in accordance with the Federal Health Council (COFESA), to the financing of established training courses and to publicity and awareness-raising activities in accordance with the objectives of this Act.

ARTICLE 22. - For cases of non-compliance with the law in public health establishments, sanctions should be applied only to officials responsible under their own sanctioning regime for their role, without prejudice to the civil and criminal responsibilities to which they may be.

ARTICLE 23. - The authority for the application of this law must establish the administrative procedure to apply in its jurisdiction for the investigation of alleged offences, ensuring the right of defence of the alleged offender and other constitutional guarantees. The role set out in this article should be coordinated with national public bodies involved in the areas covered by this law and with the jurisdictions. In addition, it may delegate to the jurisdictions the substance of the procedures to give rise to the alleged offences and to grant them their representation in the handling of the judicial remedies to be brought against the sanctions applied. Exhausted the administrative channel shall proceed to appeal in judicial headquarters directly to the Federal Appeals Chamber with jurisdiction in the place of the act. The remedies against the implementation of the envisaged sanctions will have a devolutionary effect. For substantial reasons, in order to avoid an irreparable levy to the person concerned or to safeguard third parties, the remedy may be granted with suspensive effect.

Chapter IX

Accession

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

ARTICLE 25. - Contact the national executive branch.

IN THE SESSION OF THE ARGENTINE CONGRESS, IN GOOD AIRES, TO THE TRECE DAYS OF THE MONTH YEAR DOS MIL TRECE.

# 26,906 #

BEATRIZ ROJKES DE ALPEROVICH. - JULIAN A. DOMINGUEZ. — Juan H. Estrada. - Gervasio Bozzano.