{"id":668,"date":"2020-02-10T17:14:47","date_gmt":"2020-02-10T17:14:47","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=668"},"modified":"2026-10-07T00:18:59","modified_gmt":"2026-10-07T00:18:59","slug":"what-is-a-third-party-reviewer-for-medical-devices","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/what-is-a-third-party-reviewer-for-medical-devices\/","title":{"rendered":"What is a Third Party Reviewer for Medical Devices?"},"content":{"rendered":"

Last Updated: October 2026<\/span><\/i>\u00a0<\/span><\/p>\n

Third Party Reviewers are no longer available as a route for obtaining a medical device Sanitary Registration in Mexico.\u00a0<\/strong><\/p>\n

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Historically, a third party reviewer, commonly referred to as a TPR, was a company authorized by COFEPRIS to review a medical device Sanitary Registration application and issue a technical opinion regarding its compliance with Mexican regulatory requirements.<\/span>\u00a0<\/span><\/p>\n

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In other words, a TPR was an organization that met the applicable legal requirements to help COFEPRIS by performing a previous review of a Sanitary Registration request and speeding up the approval process.\u00a0\u00a0<\/span>\u00a0<\/span><\/p>\n

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However, this regulatory pathway is no longer in force for medical device Sanitary Registration applications. Medical device companies should therefore not consider a Third Party Reviewer as a current stakeholder or available submission route in a regulatory project in Mexico.<\/span>\u00a0<\/span><\/p>\n

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Are Third Party Reviewers Still Available for Medical Devices in Mexico?<\/span><\/b>\u00a0<\/span><\/h3>\n

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No. Medical device Sanitary Registration applications can no longer undergo the preliminary review process previously performed by Third Party Reviewers.<\/span>\u00a0<\/span><\/p>\n

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References to Third Party Reviewers in older articles, presentations, diplomatic materials, databases, or AI-generated answers may reflect a process that was previously available but is no longer part of the current medical device registration pathway.<\/span>\u00a0<\/span><\/p>\n

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This distinction is important because the broader legal figure of an Authorized Third Party, or Tercero Autorizado, continues to exist in Mexico for specific health-regulatory activities. Nevertheless, the continued use of this term does not mean that companies can currently engage an Authorized Third Party to pre-review a medical device registration dossier or obtain a technical report for its submission to COFEPRIS.<\/span>\u00a0<\/span><\/p>\n

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How Did the Former Third Party Reviewer Process Work?<\/span><\/b>\u00a0<\/span><\/h3>\n

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Under the former process, Third Party Reviewers could review Sanitary Registration applications submitted through the <\/span>ordinary registration process<\/span><\/a>. Applications submitted under an <\/span>equivalency agreement<\/span><\/a> were not eligible for this preliminary review.<\/span>\u00a0<\/span><\/p>\n

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The TPR review concluded with the issuance of a legal document known as a <\/span>Technical Report<\/span><\/i>. This document indicated whether the application met the applicable Mexican requirements according to the reviewer\u2019s assessment.<\/span>\u00a0<\/span><\/p>\n

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COFEPRIS retained the authority to review the application and the information submitted, even when a favorable Technical Report had been issued. Ultimately, COFEPRIS remained the only authority empowered to grant or deny the medical device Sanitary Registration.<\/span>\u00a0<\/span><\/p>\n

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What Were the Advantages and Drawbacks of the Former Process?<\/span><\/b>\u00a0<\/span><\/h3>\n

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When the Third Party Reviewer route was available for medical device registration applications, its main potential advantages and drawbacks included:<\/span>\u00a0<\/span><\/p>\n

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Advantages<\/span>\u00a0<\/span><\/p>\n