{"id":558,"date":"2024-01-13T23:02:10","date_gmt":"2024-01-13T22:02:10","guid":{"rendered":"http:\/\/www.solumarkcr.com\/?p=558"},"modified":"2025-07-23T18:43:58","modified_gmt":"2025-07-23T16:43:58","slug":"medical-devices-registration-from-united-states","status":"publish","type":"post","link":"https:\/\/www.solumarkcr.com\/en\/medical-devices-registration-from-united-states\/","title":{"rendered":"Medical Devices registration of products from United States"},"content":{"rendered":"

Medical Devices registration from United States<\/p>\n

The Ministry of Health of Costa Rica has an agreement to simplify procedures for medical devices (EMB) that has the Certificate of Foreign Governments (CFG) issued by the FDA. This includes products manufactured in the United States and\/or owner of the product is an American company and that has the respective certificate.<\/p>\n

The foregoing due to the existing experience, knowledge and confidence, with respect to the relevant measures for the evaluation of the safety and effectiveness of the EMB. Today this benefit apply only for the United States, but the new Registrations Regulation allow other Ministries of Health in other countries to apply for equivalence and has this simplification of requirements.<\/p>\n

In resume the requirements to register devices\u00a0 class 2, 3 and 4 are same:<\/p>\n

    \n
  1. Foreign Government Certificate issued by the FDA, legalized<\/li>\n
  2. Power of Representation from the Titular or manufacturer of the product, legalized<\/li>\n
  3. Contrat of manufacture between the manufacturer and the titular of the product, legalized\u00a0 (not required if you buy directly from the manufacturer)<\/li>\n
  4. Technical and medical specifications of the device\u00a0 (Includes user manual, catalog, brochure)<\/li>\n
  5. Label of the product<\/li>\n
  6. When applicable: Import permit for radioactive sources<\/li>\n
  7. Fee payment: $25.00.U.S. class 2, $50.00 U.S. class 3 and 4.<\/li>\n<\/ol>\n

    The same regulation applies to the free sale certificate: it must include codes, an apostille, among others.<\/p>\n

    Contact us for more information!<\/p>\n","protected":false},"excerpt":{"rendered":"

    Medical Devices registration from United States The Ministry of Health of Costa Rica has an agreement to simplify procedures for medical devices (EMB) that has the Certificate of Foreign Governments (CFG) issued by the FDA. This includes products manufactured in the United States and\/or owner of the product is an American company and that has…<\/p>\n","protected":false},"author":2,"featured_media":556,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[63,62,64],"class_list":["post-558","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-emb-con-fda","tag-registro-equipo-con-fda","tag-regitros-saniatrios-productos-de-estados-unidos"],"yoast_head":"\nMedical Devices registration of products from United States - Solumark<\/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:\/\/www.solumarkcr.com\/en\/medical-devices-registration-from-united-states\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Devices registration of products from United States\" \/>\n<meta property=\"og:description\" content=\"Medical Devices registration from United States The Ministry of Health of Costa Rica has an agreement to simplify procedures for medical devices (EMB) that has the Certificate of Foreign Governments (CFG) issued by the FDA. This includes products manufactured in the United States and\/or owner of the product is an American company and that has...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.solumarkcr.com\/en\/medical-devices-registration-from-united-states\/\" \/>\n<meta property=\"og:site_name\" content=\"Solumark\" \/>\n<meta property=\"article:published_time\" content=\"2024-01-13T22:02:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-23T16:43:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.solumarkcr.com\/wp-content\/uploads\/2024\/01\/made-in-usa-logo-for-use-on-product-packaging-and-corporate-advertising-unlimited-use-per-brand-including-multiple-products-with-same-brand-name-free-vector-2.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"980\" \/>\n\t<meta property=\"og:image:height\" content=\"980\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Alejandra Granados Obreg\u00f3n\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Alejandra Granados Obreg\u00f3n\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.solumarkcr.com\\\/en\\\/medical-devices-registration-from-united-states\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.solumarkcr.com\\\/en\\\/medical-devices-registration-from-united-states\\\/\"},\"author\":{\"name\":\"Alejandra Granados Obreg\u00f3n\",\"@id\":\"https:\\\/\\\/www.solumarkcr.com\\\/#\\\/schema\\\/person\\\/05d02ab18903773fb1a2e379317a9a11\"},\"headline\":\"Medical Devices registration of products from United States\",\"datePublished\":\"2024-01-13T22:02:10+00:00\",\"dateModified\":\"2025-07-23T16:43:58+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.solumarkcr.com\\\/en\\\/medical-devices-registration-from-united-states\\\/\"},\"wordCount\":233,\"image\":{\"@id\":\"https:\\\/\\\/www.solumarkcr.com\\\/en\\\/medical-devices-registration-from-united-states\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.solumarkcr.com\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/made-in-usa-logo-for-use-on-product-packaging-and-corporate-advertising-unlimited-use-per-brand-including-multiple-products-with-same-brand-name-free-vector-2.jpg\",\"keywords\":[\"EMB con FDA\",\"registro equipo con FDA\",\"regitros saniatrios productos de Estados Unidos\"],\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.solumarkcr.com\\\/en\\\/medical-devices-registration-from-united-states\\\/\",\"url\":\"https:\\\/\\\/www.solumarkcr.com\\\/en\\\/medical-devices-registration-from-united-states\\\/\",\"name\":\"Medical Devices registration of products from United States - 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