{"id":9919,"date":"2016-12-15T09:17:08","date_gmt":"2016-12-15T12:17:08","guid":{"rendered":"http:\/\/www.amchamchile.cl\/?p=149393"},"modified":"2016-12-15T09:17:08","modified_gmt":"2016-12-15T12:17:08","slug":"regulacion-el-talon-de-aquiles-de-la-industria-de-dispositivos-medicos-en-chile","status":"publish","type":"news","link":"https:\/\/amchamchile.cl\/en\/noticia\/regulacion-el-talon-de-aquiles-de-la-industria-de-dispositivos-medicos-en-chile\/","title":{"rendered":"[:es]Regulaci\u00f3n, el tal\u00f3n de Aquiles de la industria de dispositivos m\u00e9dicos en Chile[:en]Regulation: the Achilles\u2019 heel of the Chilean medical device industry[:]"},"content":{"rendered":"

[:es]Expertos concuerdan en regular la fabricaci\u00f3n e importaci\u00f3n seg\u00fan el nivel de riesgo o invasividad del producto y advierten la necesidad de validar certificaciones extranjeras. Lo anterior, contribuir\u00e1 en la aplicaci\u00f3n de mejores est\u00e1ndares y en el acceso a nuevas terapias para pacientes.<\/em><\/p>\n

Por Kamila Cortez<\/em><\/p>\n

Desde una jeringa a un marcapasos, considerando tambi\u00e9n software de uso m\u00e9dico, as\u00ed de amplio es el concepto que engloba a los Dispositivos M\u00e9dicos (DM). Muchos de ellos corresponden a art\u00edculos de nuestra vida diaria como parches curitas, term\u00f3metros, aeroc\u00e1maras para inhalaci\u00f3n, pasando por aquellos imprescindibles en la evaluaci\u00f3n y diagn\u00f3stico de enfermedades, como equipos de rayos, reactivos para an\u00e1lisis de sangre, equipos de tomograf\u00eda computarizada. A ello se suman dispositivos que ayudan prolongar la vida y su calidad como marcapasos, pr\u00f3tesis y equipos de di\u00e1lisis. En otras palabras, los dispositivos m\u00e9dicos corresponden a una gran cantidad de art\u00edculos, equipos, instrumentos y elementos que se utilizan en medicina en beneficio de nuestra salud y que son esenciales para que la prevenci\u00f3n, el diagn\u00f3stico, el tratamiento y la rehabilitaci\u00f3n de enfermedades y dolencias sean seguros y eficaces. Estos productos desempe\u00f1an un papel esencial en la red de salud p\u00fablica y son fundamentales en los tratamientos y terapias de alta complejidad y en el desarrollo ortop\u00e9dico con miras a una sociedad m\u00e1s inclusiva.<\/p>\n

Actualmente en el pa\u00eds, la fabricaci\u00f3n nacional de dispositivos representa cerca de\u00a0 10% del mercado total, incluyendo principalmente la manufactura de kits<\/em> de diagn\u00f3stico in vitro<\/em>, concentrados de di\u00e1lisis, ropa quir\u00fargica, algunos implantes dentales, mallas para incontinencia y guantes de l\u00e1tex, entre otros. El 90% restante, son productos importados, provenientes de EE.UU., 33%; de Alemania, 14%; China, 10,5%; M\u00e9xico, 4%; Jap\u00f3n, 3,8% y \u00a034,3% de otros pa\u00edses, seg\u00fan el Medical Device Market by Product Area, 2014.<\/p>\n

La normativa chilena clasifica los dispositivos en cuatro grupos seg\u00fan el nivel de riesgo asociado. En la Clase I se identifican los de menor riesgo, como vendajes, collares cervicales y estetoscopios; en la Clase II, pr\u00f3tesis dentales removibles y guantes quir\u00fargicos; la Clase III considera elementos como preservativos, equipos de di\u00e1lisis y m\u00e1quinas de anestesia; mientras que la Clase IV, la de mayor riesgo, incluye dispositivos intrauterinos, implantes y v\u00e1lvulas card\u00edacas, entre otros.<\/p>\n

Cambios a la normativa chilena<\/strong><\/p>\n

Los dispositivos m\u00e9dicos en Chile son regulados por el art\u00edculo 111 del C\u00f3digo Sanitario y el DS 825\/98, que establece el control y certificaci\u00f3n de calidad de los productos fabricados, importados, comercializados o distribuidos en el pa\u00eds, el que debe realizarse por entidades que cuentan con la autorizaci\u00f3n del Instituto de Salud P\u00fablica (ISP).<\/p>\n

El DS 825\/98, en su art\u00edculo 22, estableci\u00f3 que mediante decretos supremos se har\u00eda efectiva, y progresivamente, la aplicaci\u00f3n del reglamento a los distintos dispositivos y elementos m\u00e9dicos. No obstante, Juan Alberto Lecaros, director del Observatorio de Bio\u00e9tica y Derecho de la Universidad del Desarrollo (UDD), plantea que la legislaci\u00f3n actual es deficiente para garantizar la seguridad de los dispositivos importados de mayor riesgo, puesto que a la fecha, en Chile, existe un solo un organismo certificador para realizar controles de calidad y s\u00f3lo opera para cinco dispositivos: guantes de examinaci\u00f3n y quir\u00fargicos, preservativos, agujas y jeringas hipod\u00e9rmicas.<\/p>\n

\u201cNo hay, por tanto, capacidad instalada para que se siga la actual norma que exige que todos los dispositivos -siendo muy relevantes aquellos calificados de mayor riesgo, como los dispositivos invasivos implantables y de uso prolongado- cuenten con control de calidad y certificaci\u00f3n por entidades certificadoras locales\u201d, alerta el acad\u00e9mico.<\/p>\n

Lecaros comenta que mediante la nueva Ley de F\u00e1rmacos II -actualmente en la Comisi\u00f3n de Salud del Senado- se est\u00e1n analizando modificaciones al art\u00edculo 111 que regula los dispositivos m\u00e9dicos que, en lo esencial, permitir\u00edan que, en caso de no existir certificadoras en Chile de dispositivos de riesgo, se puedan reconocer las certificaciones del extranjero.<\/p>\n

\u201cSi bien las reglas principales de esta modificaci\u00f3n van en la l\u00ednea correcta, se podr\u00eda simplificar la ley y dejar m\u00e1s espacio al reglamento respectivo. El mayor impacto al mercado de los dispositivos no lo produce esta normativa, sino la Ley Ricarte Soto que regul\u00f3 los ensayos cl\u00ednicos, cuyas deficientes reglas, muy por fuera del est\u00e1ndar internacional, desincentivar\u00e1n la producci\u00f3n nacional de dispositivos\u201d, afirma Lecaros.<\/p>\n

Por su parte, la Dra. Mar\u00eda Teresa Valenzuela, vicedecana de Investigaci\u00f3n y Postgrado Facultad de Medicina de la Universidad de los Andes, comenta que esta propuesta de Ley F\u00e1rmacos II establece la necesidad de contar con una regulaci\u00f3n de este mercado. Sin embargo, advierte que dado la gran cantidad de dispositivos m\u00e9dicos existentes, los avances que puedan realizarse en torno al control de ellos, deben ser graduales, priorizados por riesgo o invasividad. \u201c(Esta ley) lograr\u00e1 tener un impacto positivo, siempre y cuando se haga una priorizaci\u00f3n de cu\u00e1les de ellos debieran ser sometidos a control, que ser\u00edan de acuerdo a criterios de invasividad\u201d, sostiene la acad\u00e9mica.<\/p>\n

\"untitled\"<\/p>\n

Las modificaciones, se\u00f1ala Janepsy D\u00edaz, jefa del Departamento de Asuntos Cient\u00edficos del ISP, permitir\u00e1n mejorar el sistema de inscripci\u00f3n de proveedores y distribuidores, para poder cumplir con las atribuciones de fiscalizaci\u00f3n de las instalaciones, ampliar la lista de productos bajo control obligatorio, optimizando su proceso de registro, asegurando a la poblaci\u00f3n el acceso a productos seguros y eficaces. \u201cEn este mismo af\u00e1n, se ha propuesto un mecanismo de vigilancia sanitaria post venta, que en el caso de los dispositivos m\u00e9dicos se denomina tecnovigilancia, para verificar que los est\u00e1ndares iniciales se mantienen en el tiempo y en nuestra poblaci\u00f3n\u201d, afirma.<\/p>\n

D\u00edaz destaca que el principal impacto de las modificaciones ser\u00eda el aumento del control sanitario de estos productos, garantizando a la poblaci\u00f3n la seguridad, eficacia y la apropiada trazabilidad de ellos, desde el proveedor al centro asistencial en donde se utilice y hasta el propio paciente, en el caso de dispositivos m\u00e9dicos implantables.<\/p>\n

Valenzuela a\u00f1ade que los pa\u00edses, en general, si bien no realizan los controles de calidad, la tecnovigilancia, que pretende recoger la informaci\u00f3n de eventos adversos asociados a dispositivos m\u00e9dicos de modo de verificar la seguridad de ellos, y la fiscalizaci\u00f3n, son obligatorios.<\/p>\n

\u201cLas normas que deben cumplir los dispositivos m\u00e9dicos son la ISO 13485, que describe la gesti\u00f3n de calidad en la fabricaci\u00f3n de ellos. En Chile existe s\u00f3lo un organismo certificador de la calidad de estos productos, el Centro de Estudios de Medici\u00f3n y Certificaci\u00f3n de Calidad, Cesmec\u201d, comenta.<\/p>\n

Diferenciaci\u00f3n<\/strong><\/p>\n

Desde la vereda de los privados ven con muy buenos ojos las modificaciones, pues, como indica Esteban Gonz\u00e1lez, LA Regulatory Affairs & Quality Compliance Leader Health Care Business de 3M, \u201cChile es pr\u00e1cticamente el \u00fanico pa\u00eds de la regi\u00f3n que no regula los dispositivos m\u00e9dicos. Hay que diferenciar la certificaci\u00f3n de calidad del control de calidad, los productos que ingresan al pa\u00eds cuentan con una certificaci\u00f3n emitida por un fabricante, pero hoy no pasan por un control de una autoridad sanitaria\u201d.<\/p>\n

El ejecutivo se\u00f1ala que la regulaci\u00f3n va a mejorar la certeza, desde el punto del regulador, de la calidad y efectividad de los productos que se comercializan en Chile. No obstante, toda regulaci\u00f3n implica la realizaci\u00f3n de controles y el cumplimiento de la industria de los nuevos requerimientos, que dependiendo de c\u00f3mo se realicen, pueden generar cambios en tiempos de registro y costos, entre otros. \u201cEsto no es malo para la industria, ya que establece normas, regulaciones est\u00e1ndar, las que ser\u00edan similares a las aplicadas en casi todos los pa\u00edses de la regi\u00f3n\u201d, afirma.<\/p>\n

Gonz\u00e1lez a\u00f1ade que a nivel internacional, se est\u00e1 trabajando en la armonizaci\u00f3n y convergencia en la regulaci\u00f3n. Por ejemplo, la Organizaci\u00f3n Mundial de la Salud a trav\u00e9s de su Grupo de Trabajo para la Armonizaci\u00f3n Global de Dispositivos M\u00e9dicos -IMDRF (International Medical Devices Regulators Forum)–<\/span> ha emitido recomendaciones a los gobiernos en cuanto a implementar sistemas de regulaci\u00f3n armonizados. B\u00e1sicamente, la armonizaci\u00f3n consiste en validar las certificaciones de calidad, ya sea de proceso, manufactura o del producto mismo, cuando \u00e9stas vienen de pa\u00edses que cuentan con agencias de alta vigilancia, como por ejemplo, Estados Unidos, pa\u00edses miembros de la Uni\u00f3n Europea, Canad\u00e1, Reino Unido, Australia y Jap\u00f3n.<\/p>\n

Concuerda en este punto Tulio Oliveira, Business Unit Director – Southern Cluster de Johnson & Johnson, quien advierte que Chile necesita alcanzar una normativa que est\u00e9 en l\u00ednea con el est\u00e1ndar internacional, que entienda las caracter\u00edsticas particulares de esta industria, favoreciendo el acceso a estos dispositivos.<\/p>\n

Si bien est\u00e1 de acuerdo con avanzar en regulaciones para tener dispositivos de calidad, seguros y eficientes, plantea que es necesario diferenciar la discusi\u00f3n legislativa en torno a los medicamentos, de la de dispositivos m\u00e9dicos, pues estos \u00faltimos se siguen debatiendo en el marco de la Ley de F\u00e1rmacos II, en circunstancias que requieren debates diferenciados.<\/p>\n

\u201cHay que mantener un ambiente regulado, pero al mismo tiempo asegurar el acceso de la poblaci\u00f3n, evitando las barreras econ\u00f3micas o t\u00e9cnicas que lo puedan dificultar\u201d, enfatiza Oliveira.<\/p>\n

El ejecutivo se\u00f1ala que una de las claves para el desarrollo del sector est\u00e1 en reconocer las certificaciones emitidas en el extranjero por autoridades sanitarias de Estados Unidos, la Uni\u00f3n Europea, Canad\u00e1 y Reino Unido, ya que cuentan con un trabajo m\u00e1s avanzado en esta materia, lo que permitir\u00e1 evitar los controles duplicados.<\/p>\n

Di\u00e1logo p\u00fablico-privado<\/strong><\/p>\n

Con el objetivo de promover un di\u00e1logo p\u00fablico-privado que contribuya en el desarrollo de la industria de dispositivos m\u00e9dicos, la C\u00e1mara Chileno Norteamericana de Comercio, AmCham Chile, conform\u00f3 un comit\u00e9 que busca utilizar la experiencia y el know how<\/em> internacional de las compa\u00f1\u00edas del sector para abordar los desaf\u00edos con foco en los est\u00e1ndares de calidad, seguridad y transparencia.<\/p>\n

\u201cLa salud es un pilar fundamental para el bienestar de toda la poblaci\u00f3n y un elemento esencial para alcanzar un desarrollo equitativo e inclusivo. Es por ello que, a trav\u00e9s del Comit\u00e9 de Salud, nos interesa promover el di\u00e1logo p\u00fablico-privado, contribuyendo de manera activa en el proceso de transformaci\u00f3n del sector hasta alcanzar los m\u00e1s altos est\u00e1ndares de calidad, seguridad y transparencia en su impacto en la salud p\u00fablica\u201d, sostiene Tatiana Molina, gerente de Contenido de AmCham Chile.<\/p>\n

Agrega que en la industria de la salud, el sector de dispositivos m\u00e9dicos es uno de los segmentos de negocio m\u00e1s complejos y desafiantes, en el cual existe una estrecha colaboraci\u00f3n entre la ciencia y la ingenier\u00eda, haciendo que esta industria evolucione de manera r\u00e1pida y constante, y con un foco en el bienestar de las personas.<\/p>\n

En conclusi\u00f3n, habr\u00e1 que ver c\u00f3mo avanzan las modificaciones al art\u00edculo 111 de la Ley de F\u00e1rmacos II en el Congreso. Lo anterior, para ver los avances en esta materia que permitan al pa\u00eds ganar en calidad, pero tambi\u00e9n en disponibilidad y acceso a dispositivos m\u00e9dicos.[:en]Experts agree on the need to regulate manufacturing and imports based on the level of risk or invasiveness involved and warn about the importance of validating foreign certification. These actions will contribute to the application of improved standards and increased patient access to new treatments.\u00a0 <\/em><\/p>\n

By Kamila Cortez<\/em><\/strong><\/p>\n

The concept of what constitutes a medical device is broad, ranging from a syringe, to a pacemaker, to medical software. Many of these devices relate to articles that are used on a daily basis by a large number of people, including band-aids, thermometers and spacers for inhalers, as well as others that are essential for the evaluation and diagnosis of medical conditions, such as X-ray equipment, blood analysis machines and CT scanners. Medical devices also include items that help to prolong and improve the quality of life, including mechanical ventilators, prostheses and dialysis machines. In other words, the term \u2018medical device\u2019 corresponds to a great variety of articles, equipment, instruments and elements that are used in the medical field to improve the health of patients and which are crucial for the safe and efficient prevention, diagnosis, treatment and rehabilitation of illness, disease and injury. These devices play a central role in the development of public health and are critical to highly complex and orthopedic treatments and therapies; all with a view to help secure a more inclusive society.<\/p>\n

In terms of the current Chilean medical device industry, domestic manufacturing accounts for approximately 10% of the total market. The principal devices made in Chile include in vitro diagnostic kits, dialysis concentrates, surgical clothing, certain dental implants, incontinence nets and latex gloves, among others. The remaining 90% of medical devices present in the Chilean market are imported and according to the study, Medical Device Market by Product Area 2014, the breakdown of these imports is as follows: 33% comes from the United States; 14% from Germany; 10.5% from China; 4% from Mexico; 3.8% from Japan; and 34.3% from other countries.<\/p>\n

Chilean law classifies medical devices as belonging to one of four groups, according to their associated level of risk. Class 1 relates to the lowest risk and includes bandages, cervical collars and stethoscopes; Class II includes removable dental prostheses and surgical gloves; Class III is comprised of elements such as condoms, dialysis machines and anesthesia machines; and Class IV, which relates to the highest risk, includes intrauterine devices and heart implants, and valves, among others.<\/p>\n

Changes to Chilean law<\/strong><\/p>\n

Medical devices in Chile are regulated by article 111 of the Health Code and Supreme Decree (DS) 825\/98. This legislation governs the quality control and certification of all products that are manufactured, imported, sold or distributed in the country. In turn, such activities can only be undertaken by entities that have secured prior authorization of the Public Health Institute of Chile (ISP).<\/p>\n

Article 22 of DS 825\/98 stipulates that the effective and progressive application of regulations pertaining to different medical devices and elements is by means of Supreme Decree. However, Juan Alberto Lecaros, director of the Observatory of Bioethics and Law at Universidad del Desarrollo, argues that legislation is insufficient in its current form to guarantee the safety of imported high-risk devices. He highlights the facts that there is only one certifying body to conduct quality controls in Chile and that this entity only assesses five devices: medical examination and surgical gloves, condoms, and hypodermic needles and syringes.<\/p>\n

\u201cTherefore, there is a lack of institutional capacity to comply with the current law which demands that all devices, particularly those classified as high risk, such as invasive implants and devices for prolonged use, must be subject to quality control and certification by domestic certifying entities\u201d, states the academic.<\/p>\n

Lecaros adds that by means of the new Medical Drug Act II, which is currently being debated by the Health Commission in the Senate, possible amendments to article 111 that regulates medical devices are being discussed. These amendments would, essentially, allow for the recognition of foreign certifications in the absence of certifying bodies in Chile.<\/p>\n

\u201cWhile the main sentiment behind this amendment is along the right lines, the act could be simplified to provide more space for the respective ruling. The greatest impact on the medical device market does not come from this legislation but rather the Ricarte Soto Act, which regulates clinical trials. (However) the deficiency of the provisions (of the Ricarte Soto Act), which are lacking in terms of international standards, will simply disincentivize national manufacturing of medical devices\u201d states Lecaros.<\/p>\n

In the opinion of Dr Mar\u00eda Teresa Valenzuela, Vice Dean for Research and Graduate Studies at the Faculty of Medicine of Universidad de los Andes, the proposals contained within the Medical Drugs Act II establish the need to regulate the medical device market. However, she warns that given the large quantity of medical devices currently on offer, any progress towards the control thereof should be undertaken gradually and with priority given to high-risk and invasive equipment. \u201c(This law) will have a positive impact, as long as it prioritizes those (devices) which need to be the subject of control, which should be based on agreements related to invasiveness criteria\u201d, she says.<\/p>\n

According to Janepsy D\u00edaz, Head of the Department of Scientific Affairs at ISP, the amendments will improve the system of registering suppliers and distributors. In turn, this will facilitate the compliance of relevant entities with their auditing responsibilities, as well as extend the list of products subject to mandatory control, optimize the registration process, and help to ensure that the general public has access to safe and effective products. \u201cTowards this end, a mechanism for post-sale health surveillance has been proposed, which in the case of medical devices is known as \u2018techno-surveillance\u2019, to verify that initial standards are maintained overtime and throughout the country\u201d, she adds.<\/p>\n

\"untitled\"<\/p>\n

D\u00edaz stresses that the main impact of the amendments will be to increase sanitary control of medical devices. This will help to guarantee that the general public has access to safe, effective and appropriate equipment that is traceable from the supplier to the medical center where it is used, including in the case of medical devices that are implanted into patients.<\/p>\n

Valenzuela states that most countries do not tend to implement quality control. However, she points out that techno-surveillance, which proposes to collect information related to adverse events occurring with a medical device by verifying its safety, as well as ongoing auditing is obligatory.<\/p>\n

\u201cThe standards with which medical devices should comply are outlined in ISO 13485, which relates to quality management in manufacturing. In Chile, there is only one certification body overseeing the quality of these products, the Centre for Measurement Study and Quality Certification (CESMEC)\u201d, she notes.<\/p>\n

Differentiation<\/strong><\/p>\n

The view from the private sector in regard to the legislative amendments is favorable. Esteban Gonz\u00e1lez, LA Regulatory Affairs & Quality Compliance Leader of the Health Care Business at 3M says that, \u201cChile is practically the only country in the region that does not regulate medical devices. It is important to differentiate between quality certification and quality control because products entering the country may have certification that is issued by a manufacturer, but they do not currently undergo quality control by a health-related body\u201d.<\/p>\n

Gonz\u00e1lez believes that the legislation will improve the level of certainty, from the point of view of the regulator, in relation to the quality and effectiveness of the products that are sold in Chile. However, any regulation implies the application of controls and industry compliance with the new requirements. Depending on how these new requirements are implemented, it is likely that they will lead to changes in registration times and costs, among other factors. \u201cThis is not a bad thing for the industry because it establishes rules, regulations and standards that should be the same as those applied across virtually all countries in the region\u201d, he states.<\/p>\n

Gonz\u00e1lez adds that steps are being taken at the international level to harmonize and connect regulation in this field. For example, the World Health Organization, by means of its International Medical Device Regulators Forum (IMDRF), has published recommendations to governments on the implementation of harmonized regulation systems. Essentially, the harmonization consists of validating quality certifications, whether they relate to processes, manufacturing, or the product itself, as well as in cases when devices stem from countries that have strict quality control agencies, including the United States, members of the European Union, Canada, the United Kingdom and Japan.<\/p>\n

Tulio Oliveira, Business Unit Director – Southern Cluster at Johnson & Johnson, shares this view. He warns that Chile needs to pass new legislation in this area and to do so in line with international standards. He also argues that this legislation should understand the particular characteristics of the industry by helping to increase access to medical devices.<\/p>\n

On one hand, Oliveira agrees that new regulations are required to ensure quality, safe and efficient medical devices. On the other, he states that it is necessary to differentiate between legislative discussions about medicines and those related to medical devices. The latter, he states, are still being debated under the framework of the Medical Drugs Act II, in circumstances that require different kinds of discussions.<\/p>\n

\u201cIt is important to maintain a regulated environment, but at the same time it is necessary to ensure that the public has access (to medical devices) by breaking down the economic or technical barriers that can make this difficult\u201d, he notes.<\/p>\n

Oliveira claims that one of the key aspects for the development of the sector is to recognize certifications issued by health authorities in the United States, the European Union, Canada and the United Kingdom, since they have conducted more advanced work in this field. This will help to avoid duplications in terms of control measures.<\/p>\n

Public-private dialogue<\/strong><\/p>\n

In order to promote dialogue between the public and private sector as a means of contributing to the development of the medical devices industry, the Chilean-American Chamber of Commerce, AmCham Chile, has formed a committee that specializes in this field. The aim of this committee is to leverage international experience and know-how of companies operating in the sector to address the main challenges related to standards of quality, safety and transparency.<\/p>\n

\u201cHealth is a fundamental pillar of the wellbeing of the general public and an essential element in achieving equitable and inclusive development. That is why we are interested in promoting public-private dialogue through the Health Committee, actively contributing to the process of transforming the sector so that it reaches the highest possible standards of quality, safety and transparency in terms of its impact on public health\u201d, explains Tatiana Molina, Content Manager at AmCham Chile.<\/p>\n

She adds that in the healthcare industry, the medical devices sector is one of the most complex and challenging business segments but in which there is close collaboration between science and engineering. This means that the industry is subject to rapid and continuous evolution, with emphasis on the wellbeing of individuals.<\/p>\n

In conclusion, it will be necessary to monitor the progress of the amendments to article 111 of the Medical Drugs Act II in Congress. In particular, it is important to gauge how advantageous advancements in this field will be to the country, not only in regard to quality, but also in terms of availability and access to medical devices.[:]<\/p>\n","protected":false},"excerpt":{"rendered":"

[:es]Expertos concuerdan en regular la fabricaci\u00f3n e importaci\u00f3n seg\u00fan el nivel de riesgo o invasividad del producto y advierten la necesidad de validar certificaciones extranjeras. Lo anterior, contribuir\u00e1 en la aplicaci\u00f3n de mejores est\u00e1ndares y en el acceso a nuevas terapias para pacientes. Por Kamila Cortez Desde una jeringa a un marcapasos, considerando tambi\u00e9n software […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"template":"","news_tax":[],"user_type":[],"class_list":["post-9919","news","type-news","status-publish","hentry"],"acf":[],"yoast_head":"\n[:es]Regulaci\u00f3n, el tal\u00f3n de Aquiles de la industria de dispositivos m\u00e9dicos en Chile[:en]Regulation: the Achilles\u2019 heel of the Chilean medical device industry[:] - AmCham Chile<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/amchamchile.cl\/noticia\/regulacion-el-talon-de-aquiles-de-la-industria-de-dispositivos-medicos-en-chile\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"[:es]Regulaci\u00f3n, el tal\u00f3n de Aquiles de la industria de dispositivos m\u00e9dicos en Chile[:en]Regulation: the Achilles\u2019 heel of the Chilean medical device industry[:] - AmCham Chile\" \/>\n<meta property=\"og:description\" content=\"[:es]Expertos concuerdan en regular la fabricaci\u00f3n e importaci\u00f3n seg\u00fan el nivel de riesgo o invasividad del producto y advierten la necesidad de validar certificaciones extranjeras. Lo anterior, contribuir\u00e1 en la aplicaci\u00f3n de mejores est\u00e1ndares y en el acceso a nuevas terapias para pacientes. 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