Last Updated: October 2026
Third Party Reviewers are no longer available as a route for obtaining a medical device Sanitary Registration in Mexico.
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.
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.
However, this regulatory pathway is no longer in force for medical device Sanitary Registration applications.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.
Are Third Party Reviewers Still Available for Medical Devices in Mexico?
No. Medical device Sanitary Registration applications can no longer undergo the preliminary review process previously performed by Third Party Reviewers.
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.
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.
How Did the Former Third Party Reviewer Process Work?
Under the former process, Third Party Reviewers could review Sanitary Registration applications submitted through the ordinary registration process. Applications submitted under an equivalency agreement were not eligible for this preliminary review.
The TPR review concluded with the issuance of a legal document known as a Technical Report. This document indicated whether the application met the applicable Mexican requirements according to the reviewer’s assessment.
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.
What Were the Advantages and Drawbacks of the Former Process?
When the Third Party Reviewer route was available for medical device registration applications, its main potential advantages and drawbacks included:
Advantages
- Optimized approval times
- Reduced uncertainty regarding the requirements to be evaluated by COFEPRIS
- Identification of incorrect or incomplete information
- TPR feedback and support after the COFEPRIS submission and review
Drawbacks
- Additional costs
- Applications submitted through equivalency routes were not eligible
- Approval times remained subject to COFEPRIS capacity and availability
- A favorable review or Technical Report did not guarantee that COFEPRIS would grant the Sanitary Registration
These advantages and drawbacks are included only as a historical explanation of how the former route operated. They should not be interpreted as features of a registration pathway that is currently available to medical device companies.
Why Is the Term “Authorized Third Party” Still Used in Mexico?
The term can cause confusion because Authorized Third Parties continue to be recognized for other regulatory activities in Mexico.
On September 2, 2026, the Mexican Ministry of Health published in the Official Gazette of the Federation an Agreement issuing the Guidelines for Applications for Third-Party Authorization, their modifications, and extensions of validity.
These Guidelines define an Authorized Third Party as an individual or legal entity authorized to support sanitary control activities, including issuing opinions regarding compliance with requirements established by the Ministry of Health or conducting studies for health-related procedures and authorizations.
Most importantly, Article 8 identifies the following authorization categories:
- Testing laboratories performing analytical methodologies for products intended for human use or consumption and health supplies;
- Interchangeability units performing bioavailability, bioequivalence, or dissolution-profile studies for medicines; and
- Biocomparability units performing preclinical, clinical, or analytical studies involving biotechnology medicines.
The listed categories do not establish a category of Authorized Third Party that performs preliminary reviews of medical device Sanitary Registration dossiers.
Key Takeaway
A Third Party Reviewer was previously an organization authorized to conduct a preliminary review of a medical device Sanitary Registration application and issue a Technical Report before evaluation by COFEPRIS.
That pathway is no longer available for medical device registrations in Mexico.
Although the broader figure of the Authorized Third Party remains active for certain analytical, interchangeability, and biocomparability activities, it should not be confused with the former Third Party Reviewer route for medical device registration dossiers.
For a complete and up-to-date overview of the medical device registration process in Mexico, consult our Ultimate Guide for Regulatory Affairs in Mexico.