Introduces Modifications To The Health Code


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"Article 1.-Introducense the following modifications to the sanitary code: i. the heading of paragraph II of the preliminary title of" national health service"shall be replaced by the following:"Services of health"."

II. Article 9: 1.-replace your heading with the following: "article 9.-without prejudice to the powers of the Ministry of health and the Institute of public health of Chile, as well as from other faculties that confer them laws, corresponds particularly to the directors of health services in their respective territories:".

(2 replaced its letter c) by the following: "c) request the President of the Republic, through the Ministry of health, the enactment of the regulations of this code and propose the rules that must regulate the functions of health order carried out by municipalities;".

(3 delete, in its letter d), the word "Public".

(Replaced 4, in its letter e), the expression "Director-General" by "Director of the service".

(5 replaced the letter f) with the following: "f) reduce or waive, in exceptional cases and for reasons founded, rights that must be paid by the performances of services, fixed by the tariff approved by the Ministry of health, to certain natural or legal persons who run social care, teaching or scientific research activities. "The same powers shall be exercised by the Director of the Institute of public health of Chile, who may make them especially with regard to controls on drugs for personal needs of sick or donations in cases of emergencies or disasters, and".

(Replaced 6, in its letter g), the word "you" by "them".

III. be added to the heading of the fourth book and of its title II, the phrase "And articles of use doctor", replacing the conjunction "And" with a comma (,), in both cases.

IV. incorporate, as a new article 101, the following: ' article 101.-instruments, apparatus, devices and other items or items intended for the diagnosis, prevention and treatment of diseases of humans, as well as the replacement or modification of their anatomies and that do not apply to the substances indicated in the articles 97, 98 and 99 of this code, shall comply with the standards and quality requirements that apply to them according to their nature " (, in accordance with the following provisions: a) natural or legal persons who, at any title, manufactured, imported, placed on the market or distribute such elements, shall carry out the respective control and certification of its quality of services, institutions, laboratories and establishments with health authorization Express, granted in accordance with the provisions of article 7 of this code.
The regulation shall establish the conditions of equipment and other resources that must have the facilities, as well as the way in which you will be prompted and grant this authorization. Entities whose applications are denied or not answered within the time limit referred to in the second paragraph of article 7 of this code, may claim, within the period of 15 working days, to the Ministry of health. Regulation shall indicate the way in which this resource should be processed.

(b) the Institute of public health of Chile, will be the authority of authorizing and overseeing institutions carrying out the concerned control and certification, and must, in the absence of private bodies that develop these tasks, run them by itself.

(c) controls and quality tests to be carried out pursuant to the previous letters, are subject to the technical specifications laid down by the official standards approved and, in the absence of these, for which approval of the Ministry of health, a proposition of the mentioned Institute and on the basis of the information obtained in this area on the part of international agencies or specialized foreign entities control.
Natural or legal persons whose instruments, apparatus, devices, articles or items are rejected by the quality control of an authorized entity, may claim before the Institute of public health of Chile, within the period of fifteen working days, in the way that points to the regulation.

(d) by founded Supreme Decree of the Ministry of health, the application of the provisions of this article to different kinds or types of instruments, apparatus, devices, items and items will be effective that it treated, public health Institute proposal of Chile, which should indicate technical specifications to be subjected its quality control adopted pursuant to point (c)) and the entities who have official approval to run it or the lack of interested in obtaining this authorization.

(e) shall be competent to instruct the health summary and punish violations of these provisions the Director of the health service in the territory are committed.

(f) items that are marketed or distributed, in any capacity, without having quality certificate established in this provision, shall be forfeited, without prejudice to other measures that can be taken by the health authority.

(g) Customs destinations of these elements are subject to the provisions of law No. 18.164 and its use and disposal must be approved by the Institute of public health of Chile.
Certifications will be in exclusive charge of the natural or legal persons who request them. "."

V. Reemplazanse, in article 169, in its first paragraph, the expression "twentieth of a vital monthly salary for employees in the industry and trade of the Department of Santiago by"tenth of monthly tax unit"", and, in its second paragraph, the phrase "the Director-General of health" by the phrase "the Director of the appropriate health service or the Institute of public health of Chile , in his case, "."

VI. Replace subparagraph first of article 174 by the following: ' article 174.-violation of any of the provisions of this code or its regulations and resolutions issued by the directors of health services or the Director of the Institute of health of Chile, depending on the case, except for the provisions that have a special sanction " shall be punished by a fine of one-tenth of the monthly tax unit up to one thousand monthly tax units. Relapse can be fined up to double the original fine. "."