{"id":671,"date":"2020-02-17T15:24:52","date_gmt":"2020-02-17T15:24:52","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=671"},"modified":"2026-10-29T00:44:27","modified_gmt":"2026-10-29T00:44:27","slug":"import-permits-for-medical-devices-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/import-permits-for-medical-devices-in-mexico\/","title":{"rendered":"Import permits for Medical Devices in Mexico"},"content":{"rendered":"<p><em><span class=\"TextRun SCXW182246816 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW182246816 BCX0\">Last Updated: October 2026<\/span><\/span><span class=\"EOP Selected SCXW182246816 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/em><\/p>\n<p>In accordance with Mexican laws, importing a medical device in Mexico requires a valid Import Permit, this document is issued by <a href=\"https:\/\/www.gob.mx\/cofepris\" target=\"_blank\" rel=\"noopener noreferrer\">COFEPRIS<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<p>There are eight different types of Import Permits, the first point to consider is to know if the medical device to be imported has a sanitary registration in Mexico. If so, <strong>Case 1<\/strong> in this text must be chosen. Otherwise, when the medical device does not have a sanitary registration in Mexico or the device is under development, <strong>Cases 2 &#8211; 8<\/strong> can be chosen depending on the final use of the medical device.<\/p>\n<p>&nbsp;<\/p>\n<p><span class=\"TrackChangeTextInsertion TrackedChange SCXW253758037 BCX0\"><span class=\"TextRun SCXW253758037 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW253758037 BCX0\">Understanding which Import Permit applies to a medical device is an important regulatory consideration<\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW253758037 BCX0\"><span class=\"TextRun SCXW253758037 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW253758037 BCX0\"> when importing medical devices into Mexico, as each permit is linked to a specific regulatory status and importation purpose.<\/span><\/span><\/span><span class=\"EOP Selected TrackedChange SCXW253758037 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><strong>General Characteristics<\/strong><\/h2>\n<p><span class=\"TrackChangeTextInsertion TrackedChange SCXW263776056 BCX0\"><span class=\"TrackedChange SCXW263776056 BCX0\"><span class=\"TextRun SCXW263776056 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW263776056 BCX0\">An Import Permit is an authorization issued by COFEPRIS allowing a medical device to enter Mexico under specific conditions and for a specific purpose<\/span><\/span><\/span><\/span><span class=\"TrackChangeTextInsertion TrackedChange SCXW263776056 BCX0\"><span class=\"TextRun SCXW263776056 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW263776056 BCX0\">.<\/span><\/span><\/span><span class=\"EOP Selected TrackedChange SCXW263776056 BCX0\" data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p>Every Import Permit described below shares the following characteristics:<\/p>\n<ul>\n<li>Must be requested to COFEPRIS using the <a href=\"https:\/\/www.ventanillaunica.gob.mx\/vucem\/Ingreso.html\" target=\"_blank\" rel=\"noopener\">VUCEM<\/a> system.<\/li>\n<li>Takes around 3-5 weeks to be released upon submission to COFEPRIS.<\/li>\n<li>Valid for 180 days or to the number of pieces approved in the permit.<\/li>\n<li>After reaching such a limit another permit must be requested.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><strong>Types of Import Permits<\/strong><\/h2>\n<p>In this article we focus on describing the main characteristics and requirements rather than explaining the process to get an Import Permit.<\/p>\n<p><span class=\"TrackChangeTextInsertion TrackedChange SCXW228851693 BCX0\"><span class=\"TextRun SCXW228851693 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW228851693 BCX0\">The eight Import Permit categories differ <\/span><span class=\"NormalTextRun SCXW228851693 BCX0\">mainly according<\/span><span class=\"NormalTextRun SCXW228851693 BCX0\"> to the regulatory status of the medical device and the purpose for which it will be imported into Mexico.<\/span><\/span><\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Case 1 &#8211; <a href=\"https:\/\/veraqueconsulting.com\/mx\/ultimate-guide-for-regulatory-affairs-in-mexico\/\" target=\"_blank\" rel=\"noopener noreferrer\">Medical devices with sanitary registration<\/a><\/strong><\/h3>\n<p>A common misunderstanding is that all medical devices with sanitary registration do not require an import permit as well. Even though this type of import permit is only applicable for a certain group of medical devices (some implants or high-risk medical devices) we strongly recommend asking your custom broker or regulatory consulting firm to get the medical device tariff code to make sure if your products will require this permit.<\/p>\n<p>It is worth mentioning that this is the most common Import Permit requested to COFEPRIS because it is used on a regular basis by all companies to import a broad variety of medical devices in large quantities intended to be sold. This kind of Import Permit must be requested by the <a href=\"https:\/\/veraqueconsulting.com\/mx\/mexican-registration-holder-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\">sanitary registration holder<\/a> or by an authorized distributor as well.<\/p>\n<p>For medical devices with sanitary registration containing radiation sources e.g.\u00a0 X-ray machines and radiopaque agents. An additional Import Permit previously issued by the <a href=\"https:\/\/www.gob.mx\/cnsns\" target=\"_blank\" rel=\"noopener noreferrer\">CNSNS<\/a> is needed.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Case 2 \u2013 Medical devices for third party manufacturing<\/strong><\/h3>\n<p>In this case a medical device, is temporarily imported for a third-party manufacturing process at any stage. An authorization issued by the Secretary of Economy or <a href=\"https:\/\/www.gob.mx\/se\/acciones-y-programas\/siicex-transparencia-immex\" target=\"_blank\" rel=\"noopener noreferrer\">IMMEX<\/a> code is required.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Case 3 \u2013 Medical devices for personal use<\/strong><\/h3>\n<p>The third case applies only for patients who need a medical device not available in Mexico. The patient must request the import permit directly to COFEPRIS by submitting a valid medical prescription indicating the medical device information and the quantity needed, the import permit will be limited to this quantity.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Case 4 \u2013 Medical devices for professional use<\/strong><\/h3>\n<p>The next case is for medical devices intended to be used exclusively by a physician. This kind of import permit is useful for hospitals in need of devices not available in Mexico.<\/p>\n<p>In this case, it is the physician who must request this type of permit on behalf of a patient to be treated. Legal requirements such as professional ID must be submitted to COFEPRIS. There are additional requirements when the device to be imported is <a href=\"https:\/\/veraqueconsulting.com\/mx\/classification-and-grouping-ultimate-guide\/\" target=\"_blank\" rel=\"noopener noreferrer\">class II or III<\/a> or when it is an X-ray device.<\/p>\n<p>Generally, evidence must be presented that there is no comparable technology available in Mexico in order to justify the importation. As in <strong>Case 3<\/strong>, this import permit is limited to the number of pieces to be used for a certain patient.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Case 5 \u2013 Medical devices for human subject research <\/strong><\/h3>\n<p>This type of import permit is requested by research centers, universities and private organizations (e.g. Clinical Research Organizations) to import medical devices that will be used in clinical research studies performed in humans or when a medical device is under development and will be tested in Mexican patients. An essential requirement to get this import permit is to hold a <a href=\"https:\/\/www.gob.mx\/cofepris\/acciones-y-programas\/ensayos-clinicos-protocolos-de-investigacion-en-seres-humanos\" target=\"_blank\" rel=\"noopener noreferrer\">clinical research protocol<\/a> approved by COFEPRIS.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Case 6 \u2013 Medical devices for donations<\/strong><\/h3>\n<p>This case is only available when a foreign organization wishes to donate a medical device to public, social, or private health institutions. The organization receiving the device in Mexico must request the permit indicating the device that will be imported and assure that this product will not be sold.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Case 7 \u2013 Medical devices previously owned<\/strong><\/h3>\n<p>This case is of special interest for importing high-end or expensive medical devices. The requirements to submit to COFEPRIS are an invoice proving the device is not new, and a document with a statement indicating that the device is working properly.<\/p>\n<p>It is prudent to mention that abuse in requesting this type of import permits has led COFEPRIS to restrict or deny its approval.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Case 8 \u2013 Medical devices for laboratory testing<\/strong><\/h3>\n<p>The last case of import permits is for medical devices that will be used in laboratory tests not involving humans.<\/p>\n<p>&nbsp;<\/p>\n<h2><b><span data-contrast=\"none\">Frequently Asked Questions <\/span><\/b><b><span data-contrast=\"none\">(FAQ<\/span><\/b><b><span data-contrast=\"none\">):<\/span><\/b> <b><span data-contrast=\"none\">Import Permits for Medical Devices in Mexico<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h2>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><strong>Do all medical devices require an Import Permit in Mexico?\u00a0<\/strong><br \/>\n<span data-contrast=\"none\">No. The need for an Import Permit depends on factors such as the medical device, its tariff classification, regulatory status, and importation purpose. Even when a device already has a Sanitary Registration, an Import Permit may still be required in certain cases.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><strong>Can a medical device without a Sanitary Registration be imported into Mexico?\u00a0<\/strong><br \/>\n<span data-contrast=\"none\">Yes, under specific circumstances. Medical devices without a Sanitary Registration may be eligible for importation for purposes such as personal or professional use, clinical research, donations, laboratory testing, or other specific uses described in the applicable Import Permit categories.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><strong>How do I determine which Import Permit applies to my medical device?\u00a0<\/strong><br \/>\n<span data-contrast=\"none\">The appropriate Import Permit depends primarily on whether the device has a Sanitary Registration in Mexico and the purpose for which it will be imported. For registered devices, it is also important to verify the applicable tariff classification to determine whether an Import Permit is required.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><strong>Final considerations<\/strong><\/h2>\n<p>We highlighted the great significance of <strong>Case 1 (import permits for medical devices with sanitary registrations)<\/strong> when importing high quantities of medical devices for trade up. In all other cases quantities authorized to import will be very limited, and the devices are not always eligible for sale.<\/p>\n<p>&nbsp;<\/p>\n<p>The medical device importation in Mexico is a highly regulated activity. To successfully import a device, the right type of Import Permit must be chosen, and all requirements must be submitted to COFEPRIS. To get more information about exporting a medical device to Mexico please contact us at <a href=\"mailto:contact@veraqueconsulting.com\">contact@veraqueconsulting.com<\/a><\/p>\n<p>&nbsp;<\/p>\n<h3><span class=\"TextRun SCXW189196245 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW189196245 BCX0\" data-ccp-parastyle=\"heading 3\">Related articles:<\/span><\/span><span class=\"EOP Selected SCXW189196245 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><a href=\"https:\/\/veraqueconsulting.com\/mx\/the-use-of-tariff-codes-in-mexico-for-medical-devices\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">The use of tariff codes in Mexico for medical devices<\/span><\/a><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><a href=\"https:\/\/veraqueconsulting.com\/mx\/the-role-of-the-customs-broker-in-mexico-for-medical-devices-compliance-and-best-practices\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">The Role of the Customs Broker in Mexico for Medical Devices: Compliance and Best Practices<\/span><\/a><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><a href=\"https:\/\/veraqueconsulting.com\/mx\/next-steps-after-cofepris-sanitary-registration\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Next Steps After COFEPRIS Sanitary Registration<\/span><\/a><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Last Updated: October 2026\u00a0 In accordance with Mexican laws, importing a medical device in Mexico requires a valid Import Permit, this document is issued by COFEPRIS. &nbsp; There are eight different types of Import Permits, the first point to consider is to know if the medical device to be imported has a sanitary registration in [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":203,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17,390],"tags":[18],"class_list":["post-671","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-import-permit","category-mexico","tag-import-permit"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.6 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Import permits for Medical Devices in Mexico - Veraque Mexico<\/title>\n<meta name=\"description\" content=\"Understand the requirements to get an import permit for Medical Devices in Mexico. 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