Business Opportunities Available to Producers and Importers of Medical Equipment in Mexico

Resulting from recent modifications to the procedures of importation of drugs, medical equipment, diagnostic agents, surgical and recovery materials and hygiene products, as well as all types of goods and objects that are necessary to face the health emergency caused by the coronavirus (COVID-19), there are several business opportunities available to producers and importers of these products in Mexico. This is because now producers and importers have access to a more expeditious approval process to sell to the following entities:

1. Government: In this situation, the government does not have to comply with the Federal Commission for Protection against Sanitary Risk (COFEPRIS) authorizations and could be directly designated, meaning that the public bidding procedure is not mandatory.
2. General Public: In this case, COFEPRIS will prioritize the resolutions of the procedures that must be complied with to import and commercialize these types of goods.

This opinion derives from recent government decrees and notifications.

On March 27, 2020, a decree that details the extraordinary measures adopted in Mexico because of the health emergency situation caused by COVID-19, was published in the Federal Mexican Gazette.

The decree allows the Ministry of Health to import or authorize the importation of drugs, medical equipment, diagnostic agents, surgical and recovery materials and hygiene products, as well as all types of goods and objects that are necessary to face the health emergency without the necessity of obtaining any previous authorization.

On April 3, 2020, the Ministry of Health published a second decree in the Federal Mexican Gazette through which some points of the first decree were clarified, including that: 1) the expression "without the necessity of obtaining any previous authorization" refers to the authorizations issued by COFEPRIS and 2) that the agencies and organizations that could import with those benefits are the following:

• Department of Health
• Department of National Defense
• Department of Navy
• Institute for Welfare
• Mexican Institute of Social Security
• Institute of Security and Social Services for State Workers

In light of the above, the decrees do not provide any benefits to the private sector.

Additionally, the Tax Administration Service (SAT) published on its website an advanced version of the amendments to the General Rules of Foreign Trade, which regulate the import procedures that the agencies mentioned above must follow.

As a result, COFEPRIS issued several notifications informing private sector individuals of the procedures that they must follow to import diagnostic tests for COVID-19 as well as ventilators, as detailed below.

For the Importation of Diagnostic Tests

• COFEPRIS has designated the Institute of Epidemiological Diagnostic and Reference (InDRE) as the organization that will comparatively evaluate molecular tests for the detection of COVID-19. With this evaluation, COFEPRIS will issue a permit for the tests' commercialization, whose validity will be limited to the emergency period.
• The importation of the samples required for the evaluation will be established by InDRE. The samples may be imported for research using the code that the National Council of Science and Technology (CONACyT) or COFEPRIS has for this purpose, or through the investigation modality allowed for COFEPRIS.
• InDRE proposed to COFEPRIS to only authorize the import of molecular diagnostic tests and not rapid IgM/IgG tests.

For the Importation of Pulmonary Ventilators

• COFEPRIS published the provisions containing the minimum requirements that must be met by ventilators, their accessories and other respiratory devices. These provisions will be valid during the health emergency related to COVID-19.
• The equipment must be evaluated by the National Center for Preventive Programs and Disease Control (CENAPRECE), which will issue a technical opinion that COFEPRIS will use to determine whether to issue the respective import permit.

On April 12, 2020, COFEPRIS released the list of priority attention procedures for the health emergency derived from COVID-19, which are classified as follows:

• health import permits
• sanitary records (new, modifications to be made and time extensions)
• sanitary verification visits to:
  • obtain a certificate of good manufacturing practices for drugs
  • take samples and release narcotics and psychotropics
• new protocols
• sanitary licenses (new and modifications to be made)
• permits for sale or distribution of biological products and blood products
• certificates of support for the export of health inputs
• notices from health officials

Holland & Knight attorneys have extensive experience in customs and regulatory matters in a variety of industries. For more information, contact the authors or Holland & Knight's Mexico City office.

DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact your responsible Holland & Knight lawyer or the authors of this alert for timely advice.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem. Moreover, the laws of each jurisdiction are different and are constantly changing. If you have specific questions regarding a particular fact situation, we urge you to consult competent legal counsel.