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COFEPRIS Makes Changes to Revamp Medical Device Regulations

Updated: Apr 18

changes medical devices regulations cofepris mexico variations license transfer registration  OFICIO-CFS-325-2023

In a significant regulatory update, Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has introduced new guidelines for medical device registrations. The changes, which came into effect in August 2023, aim to streamline the review process and address the backlog of applications.

New Classification Criteria The revised guideline, released in response to OFICIO-CFS-325-2023, establishes fresh criteria for the modification of sanitary registrations of medical devices. This includes a clear definition of terms such as ‘Legal Manufacturer’ and ‘Real Manufacturer,’ ensuring clarity in the application process.

Electronic Submission A notable shift is the move towards electronic submission of modifications. Applicants must now submit changes electronically, albeit in person, using a marked USB flash drive.

Impact on Manufacturers Manufacturers must ensure that the original registration route is maintained through subsequent modifications. The guideline emphasizes the importance of selecting the best registration route for the device throughout its lifecycle.

Global Implications These updates by COFEPRIS are expected to have a positive impact on the medical device industry, both domestically and internationally, by expediting the registration process and bringing innovative medical devices to the market more swiftly.

COFEPRIS rules for changes to the health register

In response to OFICIO-CFS-325-2023, COFEPRIS issued a revised guideline on August 9, titled “Gua De Criterios Para Clasificación de Modificaciones de Registros Sanitarios de Dispositivos Médicos.” This guideline establishes the criteria and procedures for modifying sanitary registrations of medical devices.

The guideline begins by referencing the existing regulatory framework, which includes the General Health Law, Health Supplies Regulation, Mexican Pharmacopoeia, and subsequent agreements published in 2011, 2015, and early 2022. It aims to clarify the modification requirements by defining key terms:

  1. Legal Manufacturer: The natural or legal person responsible for the safety, performance, quality, design, manufacture, conditioning, assembly, restoration, modification, or adaptation of a medical device before its commercialization. This responsibility applies regardless of whether these operations are carried out by the same entity or a third party.