[passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] [passage] Paragraph II of the Preliminary Title "Of The National Health Service", as follows: "Of the Health Services". II. In his article 9º: 1.-Replace his heading with the following: " Article 9º.-Without prejudice to the privileges of the Ministry of Health and the Public Health Institute of Chile, as well as the other powers granted to them by the laws, (c) Request the President of the Republic, through the Ministry of Health, to request the President of the Republic, through the Ministry of Health, to request the President of the Republic, Regulations of this Code and propose rules to regulate the functions of health order in charge 3.-Eliminate, in point (d), the word "Public". 4.-Substitute, in point (e), the term "Director-General" by "Director of the Service". 5.-Replace his letter (f) with the following: " f) Rebar or exempt, in cases exceptional and for sound reasons, the rights to be paid for the actions of the Services, fixed by the Arancel approved by the Ministry of Health, to certain natural or legal persons who carry out assistance activities social, teaching or scientific research. The same powers shall be exercised by the Director of the Public Health Institute of Chile, which may apply them in particular with regard to controls on medicinal products for the personal needs of patients or for donations in cases of 6.-Substitute, in point (g), the word 'le' for 'les'. III. Add to the heading of the Fourth and the Book of Title II, the phrase "And Articles of Medical Use", replacing the conjunction "Y" with a comma (,), in both cases. IV. Incorporate, as new Article 101, the following: " Article 101.-The instruments, apparatus, devices and other articles or elements intended for the diagnosis, prevention and treatment of diseases of human beings, as well as to the replacement or modification of their anatomy and which do not correspond to the substances described in Articles 97, 98 and 99 of this Code, must comply with the quality standards and requirements applicable to them according to their nature, in accordance with the (a) (a) natural or legal persons who, for any degree, manufacture, import, market or distribute such elements, shall carry out the respective control and certification of their quality in services, institutions, laboratories or establishments with express health authorisation, granted in accordance with the provisions of Article 7 of this Code. The Regulation should lay down the conditions for the equipment and other resources to be provided by the establishments, as well as the way in which this authorisation will be requested and granted. Entities whose applications are denied or not answered within the period referred to in the second paragraph of Article 7 of this Code may, within 15 working days, claim before the Ministry of Health. The regulation will indicate how this resource should be dealt with. (b) The Public Health Institute of Chile shall be the body responsible for authorizing and supervising the entities carrying out the said control and certification, owing, in the absence of private bodies that carry out such tasks, to implement them in case itself. (c) the quality checks and tests to be carried out in accordance with the provisions of the preceding subparagraphs shall be subject to the technical specifications laid down by the official rules adopted and, in the absence thereof, by the Ministry of Health, on the proposal of the aforementioned Institute and on the basis of information obtained in the field from international organizations or specialized foreign control entities. Natural or legal persons whose instruments, apparatus, devices, articles or elements are rejected by the quality control of an authorized entity, may claim before the Public Health Institute of Chile, within 15 years. working days, in the way that the regulation points out. (d) By the supreme decree established by the Ministry of Health, the application of the provisions of this article to the different classes or types of instruments, apparatus, devices, articles and elements of the subject matter shall be effective. Institute of Public Health of Chile, in which the technical specifications to be subject to its quality control, approved in accordance with point (c) and the entities with official authorization to execute it or the No interested parties to obtain this authorization. (e) He shall be competent to instruct the health summary and to sanction the violations of these provisions by the Director of the Health Service in whose territory they are committed. (f) Items which are placed on the market or distributed to any title without the quality certificate provided for in this provision shall be seized, without prejudice to any other measures which the health authority may take. (g) The customs destinations of these elements shall be subject to the provisions of Law No 18.164 and their use and disposition shall be authorized by the Public Health Institute of Chile. The cost of the certifications shall be the exclusive charge of the natural or legal persons who request them. " V. Replace, in Article 169, in its first indent, the expression "20th of a monthly vital salary for the employees of the Department of Santiago" for "tenth of monthly tax unit", and, in its subsection second, the phrase "the Director General of Health" by the locution "the Director of the corresponding Health Service or the Public Health Institute of Chile, if any,". VI. Replace the first paragraph of Article 174 by the following: " Article 174.-The infringement of any of the provisions of this Code or of its regulations and of the resolutions dictated by the Directors of the Health Services or the Director The Public Health Institute of Chile, as the case may be, except for provisions that have a special sanction, will be punished with a fine of one tenth of a monthly tax unit up to a thousand monthly tax units. The reincidences may be sanctioned up to twice the original fine. " Article 2.-The regulation referred to in Article 101 of the Health Code shall be issued within 90 days from the date of publication of this law. " And because I have had to approve and sanction it; therefore, promulgate and take effect as the Law of the Republic. Santiago, March 10, 1997.-EDUARDO FREI RUIZ-TAGLE, President of the Republic.-Alex Figueroa Munoz, Minister of Health. What I transcribe to you for your knowledge.-Salute to you, Dr. Fernando Munoz Porras, Undersecretary of Health.