{"id":8453,"date":"2025-11-26T23:07:57","date_gmt":"2025-11-26T23:07:57","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8453"},"modified":"2025-11-26T23:07:57","modified_gmt":"2025-11-26T23:07:57","slug":"al-comprar-una-maquina-de-ondas-de-choque-debe-cumplir-con-la-regulacion-de-recuperacion-de-envases-de-la-ue","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/es\/when-purchasing-a-shockwave-therapy-machine-must-it-comply-with-the-eu-packaging-recovery-regulation\/","title":{"rendered":"Al comprar una m\u00e1quina de terapia de ondas de choque, \u00bfdebe cumplir con la regulaci\u00f3n de recuperaci\u00f3n de envases de la UE?"},"content":{"rendered":"

\n \"Configuraci\u00f3n\n<\/p>\n

Desde nuestra posici\u00f3n en el lado de la producci\u00f3n, a menudo vemos compradores inseguros sobre si las m\u00e1quinas de terapia de ondas de choque deben seguir el Reglamento actualizado de la UE sobre Envases y Residuos de Envases al ingresar al mercado de la UE.<\/p>\n

S\u00ed, las m\u00e1quinas de terapia de ondas de choque deben cumplir con el Reglamento de la UE sobre Envases y Residuos de Envases porque todos los envases colocados en el mercado de la UE, independientemente de la categor\u00eda del producto, est\u00e1n sujetos a la Responsabilidad Ampliada del Productor (RAP), requisitos de reciclaje y etiquetado armonizado, a menos que est\u00e9n espec\u00edficamente exentos por razones de esterilidad o integridad del producto.<\/strong><\/p>\n

Comprender estas reglas de antemano evita problemas aduaneros, retrasos en el despacho y costos de cumplimiento inesperados para los importadores.<\/p>\n

Cuando planifica con anticipaci\u00f3n, el cumplimiento de los envases se convierte en una parte predecible de su cadena de suministro en lugar de una sorpresa regulatoria.<\/p>\n

\n

\u00bfQu\u00e9 normas de embalaje se requieren para el cumplimiento medioambiental?<\/h2>\n

Desde la perspectiva de un fabricante, a menudo trabajamos con distribuidores de la UE que conf\u00edan en nosotros para dise\u00f1ar envases que cumplan con las obligaciones de reciclabilidad, marcado y documentaci\u00f3n seg\u00fan las \u00faltimas normas de la UE.<\/p>\n

Los envases para m\u00e1quinas de terapia de ondas de choque deben seguir los requisitos de la UE para la reciclabilidad del material, etiquetas armonizadas, identificaci\u00f3n precisa del material, registro de RAP y presentaci\u00f3n de informes adecuados, incluso si algunos envases de dispositivos m\u00e9dicos est\u00e1n exentos de objetivos de contenido reciclado o reciclabilidad por razones de seguridad.<\/strong><\/p>\n

\"T\u00e9cnicos<\/p>\n

El Reglamento de la UE sobre Envases y Residuos de Envases (PPWR) se aplica ampliamente a los envases colocados en el mercado, como se describe en el resumen oficial de la propuesta de PPWR<\/a><\/strong> 1<\/a><\/sup>.<\/p>\n

1. Requisitos de reciclabilidad<\/h3>\n

La mayor\u00eda de los envases vendidos en la UE deben ser reciclables por dise\u00f1o. Los criterios de reciclabilidad hacen referencia a los principios definidos en las directrices de la UE sobre envases de econom\u00eda circular<\/a><\/strong> 2<\/a><\/sup>.<\/p>\n

2. Requisitos de contenido reciclado<\/h3>\n

Los futuros umbrales obligatorios de contenido reciclado siguen los objetivos descritos en Documentos de pol\u00edtica de la UE sobre envases de pl\u00e1stico<\/a><\/strong> 3<\/a><\/sup>.<\/p>\n

3. Etiquetado armonizado<\/h3>\n

Los formatos de etiqueta, las identificaciones de material y las reglas de marcado de eliminaci\u00f3n se correlacionan con Normas de etiquetado de envases armonizadas de la UE<\/a><\/strong> 4<\/a><\/sup>.<\/p>\n

4. Minimizaci\u00f3n de envases<\/h3>\n

Los requisitos de minimizaci\u00f3n, incluidas las relaciones de espacio vac\u00edo, se mencionan en Principios de prevenci\u00f3n de residuos de envases de la UE<\/a><\/strong> 5<\/a><\/sup>.<\/p>\n

Tabla de normas de embalaje<\/h3>\n\n\n\n\n\n\n\n\n\n
Tipo de Requisito<\/th>\nDescripci\u00f3n<\/th>\n\u00bfSe aplica a Shockwave Packaging?<\/th>\n<\/tr>\n<\/thead>\n
Reciclabilidad<\/td>\nDebe ser reciclable por dise\u00f1o<\/td>\nS\u00ed (a menos que est\u00e9 exento por esterilidad)<\/td>\n<\/tr>\n
Contenido reciclado<\/td>\nObligatorio % para pl\u00e1sticos<\/td>\nParcialmente (exento si es por esterilidad)<\/td>\n<\/tr>\n
Etiquetado<\/td>\nMarcas de reciclaje armonizadas<\/td>\nS\u00ed<\/td>\n<\/tr>\n
Registro EPR<\/td>\nResponsabilidad a nivel de pa\u00eds<\/td>\nS\u00ed<\/td>\n<\/tr>\n
Minimizaci\u00f3n de envases<\/td>\nEvitar el embalaje excesivo<\/td>\nS\u00ed<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n

\u00bfLos dispositivos m\u00e9dicos y est\u00e9ticos est\u00e1n sujetos a las mismas normas de embalaje?<\/h2>\n

Los dispositivos m\u00e9dicos y est\u00e9ticos siguen el mismo marco de embalaje de la UE, pero los envases m\u00e9dicos est\u00e9riles o sensibles a la contaminaci\u00f3n pueden estar exentos de ciertas obligaciones de reciclabilidad y contenido reciclado, mientras que los dispositivos est\u00e9ticos deben seguir los requisitos completos de embalaje sin exenciones.<\/strong><\/p>\n

\"Kits<\/p>\n

El tratamiento de envases para productos relacionados con la medicina sigue las definiciones de Interpretaciones regulatorias de envases m\u00e9dicos de la UE<\/a><\/strong> 6<\/a><\/sup>.<\/p>\n

Categor\u00edas de envases de dispositivos m\u00e9dicos<\/h3>\n

La ley de la UE distingue entre:<\/p>\n

    \n
  1. Envases de barrera est\u00e9ril<\/strong> <\/li>\n
  2. Electr\u00f3nica m\u00e9dica no est\u00e9ril<\/strong> (m\u00e1quinas de ondas de choque) <\/li>\n
  3. Dispositivos est\u00e9ticos o de bienestar<\/strong> <\/li>\n<\/ol>\n

    Las m\u00e1quinas de terapia de ondas de choque entran dentro de electr\u00f3nica m\u00e9dica no est\u00e9ril<\/strong>, por lo tanto, sujetos a las reglas EPR y de reciclabilidad.<\/p>\n

    Tabla comparativa<\/h3>\n\n\n\n\n\n\n\n
    Tipo de dispositivo<\/th>\nRequisito de esterilidad<\/th>\nExenciones de reciclabilidad<\/th>\n\u00bfObligaciones completas de RPE?<\/th>\n<\/tr>\n<\/thead>\n
    M\u00e1quina de terapia de ondas de choque<\/td>\nNo est\u00e9ril<\/td>\nNo<\/td>\nS\u00ed<\/td>\n<\/tr>\n
    Herramientas quir\u00fargicas (est\u00e9riles)<\/td>\nEmbalaje est\u00e9ril<\/td>\nS\u00ed<\/td>\nS\u00ed<\/td>\n<\/tr>\n
    Dispositivos de belleza\/est\u00e9tica<\/td>\nNo est\u00e9ril<\/td>\nNo<\/td>\nS\u00ed<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n

    \u00bfQu\u00e9 documentaci\u00f3n deben proporcionar los proveedores para el cumplimiento de los envases?<\/h2>\n

    Dado que preparamos expedientes de cumplimiento para muchos clientes de la UE, sabemos que los compradores a menudo tienen dificultades para identificar qu\u00e9 documentos de embalaje son legalmente requeridos.<\/p>\n

    Los proveedores suelen hacer referencia a Requisitos de conformidad de embalaje de la UE<\/a><\/strong> 7<\/a><\/sup> al preparar la documentaci\u00f3n.<\/p>\n

    \"Expediente<\/p>\n

    Los documentos requeridos incluyen:<\/h3>\n
      \n
    1. \n

      Certificado de Registro de RPE<\/strong>
      \nLas obligaciones de RPE siguen los requisitos nacionales a los que a menudo se accede a trav\u00e9s de       Gu\u00eda de cumplimiento de RPE de la UE<\/a><\/strong> 8<\/a><\/sup>.<\/p>\n<\/li>\n

    2. \n

      Lista de composici\u00f3n de materiales de embalaje<\/strong> <\/p>\n<\/li>\n

    3. \n

      Evaluaci\u00f3n de reciclabilidad<\/strong> <\/p>\n<\/li>\n

    4. \n

      Declaraci\u00f3n de conformidad para embalajes<\/strong> <\/p>\n<\/li>\n

    5. \n

      Hoja de verificaci\u00f3n de etiquetado<\/strong> <\/p>\n<\/li>\n<\/ol>\n

      Tabla de documentaci\u00f3n<\/h3>\n\n\n\n\n\n\n\n\n\n
      Tipo de Documento<\/th>\nObjetivo<\/th>\n\u00bfNecesario?<\/th>\n<\/tr>\n<\/thead>\n
      Prueba de registro RPE<\/td>\nConfirma el cumplimiento en el pa\u00eds del mercado objetivo<\/td>\nS\u00ed<\/td>\n<\/tr>\n
      Lista de composici\u00f3n de materiales<\/td>\nProporciona transparencia en la reciclabilidad<\/td>\nS\u00ed<\/td>\n<\/tr>\n
      Declaraci\u00f3n de reciclabilidad<\/td>\nConfirma el cumplimiento o la exenci\u00f3n<\/td>\nS\u00ed<\/td>\n<\/tr>\n
      Hoja de etiquetado<\/td>\nVerifica las marcas correctas<\/td>\nS\u00ed<\/td>\n<\/tr>\n
      Declaraci\u00f3n de conformidad del embalaje<\/td>\nRequerido para auditor\u00edas e inspecciones<\/td>\nS\u00ed<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
      \n

      \u00bfC\u00f3mo deben los compradores manejar la responsabilidad del embalaje en el comercio transfronterizo?<\/h2>\n

      Los compradores deben definir claramente qui\u00e9n tiene la responsabilidad de la RPE, verificar los registros de RPE del proveedor y asegurarse de que la documentaci\u00f3n del embalaje se asigne al importador o al fabricante, seg\u00fan qui\u00e9n introduzca el producto en el mercado de la UE.<\/strong><\/p>\n

      \"Cinta<\/p>\n

      Las responsabilidades de la RPE se determinan por las normas descritas en Criterios de responsabilidad del productor de la UE<\/a><\/strong> 9<\/a><\/sup>.<\/p>\n

      Principios clave para el cumplimiento transfronterizo<\/h3>\n
        \n
      1. La responsabilidad de la RPE recae en la entidad que introduce el producto en el mercado de la UE<\/strong> <\/li>\n
      2. Responsabilidad del importador si compra a un fabricante no perteneciente a la UE<\/strong> <\/li>\n
      3. Los transitarios no asumen la RPE<\/strong> <\/li>\n
      4. Las plataformas hacen cumplir la RPE pero no sustituyen las obligaciones del importador<\/strong><\/li>\n<\/ol>\n

        Las expectativas adicionales de acceso al mercado se resumen en Gu\u00eda de cumplimiento de embalajes transfronterizos de la UE<\/a><\/strong> 10<\/a><\/sup>.<\/p>\n

        Tabla de responsabilidad transfronteriza<\/h3>\n\n\n\n\n\n\n\n\n
        Escenario<\/th>\nParte responsable de la RPE<\/th>\nNotas<\/th>\n<\/tr>\n<\/thead>\n
        Fabricante no perteneciente a la UE con entidad en la UE<\/td>\nFabricante<\/td>\nDebe registrarse en los mercados locales<\/td>\n<\/tr>\n
        Fabricante no perteneciente a la UE sin entidad en la UE<\/td>\nImportador<\/td>\nEscenario m\u00e1s com\u00fan<\/td>\n<\/tr>\n
        Distribuidor que vende dentro de la UE<\/td>\nDistribuidor o productor<\/td>\nDepende del contrato<\/td>\n<\/tr>\n
        Agente o transitario utilizado<\/td>\nNo responsable<\/td>\nSin carga de RPE<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
        \n

        Conclusi\u00f3n<\/h2>\n

        Las m\u00e1quinas de terapia de ondas de choque deben cumplir con el Reglamento de la UE sobre envases y residuos de envases, incluidas las RPE, los requisitos de reciclabilidad, etiquetado y documentaci\u00f3n. Las exenciones m\u00e9dicas son limitadas y no se aplican a la electr\u00f3nica m\u00e9dica no est\u00e9ril, lo que hace que el cumplimiento sea esencial para un acceso fluido al mercado y la sostenibilidad a largo plazo.<\/p>\n

        \n

        Notas al pie<\/h2>\n

        1. Resumen de la propuesta de la UE sobre el PPWR. \u21a9\ufe0e<\/a><\/span>
        \n2. Orientaci\u00f3n de la UE sobre envases para la econom\u00eda circular.         \u21a9\ufe0e<\/a><\/span>
        \n3. Resumen de la estrategia de pl\u00e1sticos de la UE.         \u21a9\ufe0e<\/a><\/span>
        \n4. Normas armonizadas de etiquetado de envases.         \u21a9\ufe0e<\/a><\/span>
        \n5. Principios de prevenci\u00f3n de residuos de la UE.         \u21a9\ufe0e<\/a><\/span>
        \n6. Contexto regulatorio del embalaje de dispositivos m\u00e9dicos.         \u21a9\ufe0e<\/a><\/span>
        \n7. Normas oficiales de conformidad de envases.         \u21a9\ufe0e<\/a><\/span>
        \n8. Orientaci\u00f3n del sistema de RPE de la UE.         \u21a9\ufe0e<\/a><\/span>
        \n9. Criterios de responsabilidad del productor de la UE.         \u21a9\ufe0e<\/a><\/span>
        \n10. Referencia de cumplimiento para el acceso al mercado de la UE.         \u21a9\ufe0e<\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"

        From our position on the production side, we often see buyers uncertain about whether shockwave therapy machines must follow the EU\u2019s updated Packaging and Packaging Waste Regulation when entering the EU market. Yes, shockwave therapy machines must comply with the EU Packaging and Packaging Waste Regulation because all packaging placed on the EU market\u2014regardless of […]<\/p>\n","protected":false},"author":3,"featured_media":8456,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[60],"tags":[],"class_list":["post-8453","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"\nWhen purchasing a Shockwave Therapy Machine, must it comply with the EU packaging recovery regulation? - KMSLaser<\/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:\/\/kmslaser.com\/es\/al-comprar-una-maquina-de-ondas-de-choque-debe-cumplir-con-la-regulacion-de-recuperacion-de-envases-de-la-ue\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"When purchasing a Shockwave Therapy Machine, must it comply with the EU packaging recovery regulation?\" \/>\n<meta property=\"og:description\" content=\"From our position on the production side, we often see buyers uncertain about whether shockwave therapy machines must follow the EU\u2019s updated Packaging and Packaging Waste Regulation when entering the EU market. 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