Medical Device and IVD Emergency Use Routes in Mexico

COFEPRIS is the regulatory authority for medical devices and IVDs in Mexico. Approval of these products is subject to a registration process that requires providing evidence of their safety and effectiveness. The standard process can take several months.

In light of the current COVID-19 emergency, COFEPRIS has published two official communications (March 26 and April 17) regarding its policies during this time, stating that all administrative terms and deadlines are to be stopped between March 26 and April 30, in order to deploy resources to perform essential functions related to COVID-19.

Regulations, guidance, and resources

Besides the two official publications in the Mexico Official Federal Journal from March 26 and April 17, COFEPRIS published on April 2 a statement on strategic actions for the COVID-19 emergency in their website.

In this, they stated that COFEPRIS will work together with the Ministry of Foreign Affairs (SRE) to immediately issue the necessary import permits for the reception of donated medicines and health supplies that meet quality, safety and efficacy standards.

Additionally, they provided conditions for expedited approval of ventilators and IVD test kits.

Device types and eligibility criteria

Ventilators

Ventilators must be assessed by the National Center for Preventive Programs and Disease Control (CENAPRECE) who can issue a technical approval letter, which importers can deliver to COFEPRIS to obtain an immediate marketing authorization. Further details can be found at COFEPRIS’s website.

SARS-CoV2 PCR Tests

Following the recommendations of the World Health Organization, the Ministry of Health established that the Institute of Diagnostic and Epidemiological Reference (InDRE) will evaluate IVD tests for detection of COVID-19. The InDRE can grant a technical approval letter, which importers can deliver to COFEPRIS to obtain an immediate marketing authorization. Additional information is shown on this link.

Serological COVID-19 Tests

On June 1st, COFEPRIS released an additional update (revised on August 14) allowing expedited review of IgG and IgM serological tests for COVID-19. In order to ensure their efficacy, COFEPRIS developed an evaluation protocol along with the National Institute of Nutrition and Medical Science. All serological tests submitted for approval will need to be evaluated according to the protocol (performed by TecSalud).

Pathway overview

In the case of ventilators, the criteria required by the CENAPRECE are outlined on the COFEPRIS website. Personnel at CENAPRECE have confirmed that a self-evaluation document must be submitted for their assessment, although this has not been officially published.

For SARS-CoV2 PCR tests, the InDRE will develop a special testing protocol for each device, where sensitivity, specificity, and repeatability testing will be performed. The samples will be imported through an import permit granted by COFEPRIS. Upon completion with acceptable results, the InDRE will issue an endorsement letter addressed to COFEPRIS, which will need to be submitted along with a registration dossier. COFEPRIS will respond within a few days with a temporary commercialization approval that will be valid for the duration of the emergency health situation (as determined by the federal government). The dossier will continue being evaluated and, if considered compliant, the Ministry of Health will release a valid 5-year health registration.

The case of Serological IgG and IgM tests is similar to the above, but in this case the first step is submitting a Class II dossier to COFEPRIS, and if the preliminary assessment determines the information adequate, COFEPRIS will allow the importation of samples to be tested by TecSalud. If these local tests are successful, COFEPRIS will release a temporary marketing approval, while review of the original dossier continues. If accepted, COFEPRIS will issue a 5-year registration certificate.

Through informal communications, COFEPRIS has clarified that the aforementioned approvals are not only subject to the approval letters provided by the CENAPRECE, InDRE, or TecSalud respectively. Requests for said temporary marketing and import permit will also be subject to submission of the regular documentation requirements requested by COFEPRIS, as listed in the submission type requirements COFEPRIS-04-001-B.

Updated on 21 August 2020.

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