Introduction
General requirements for importing products
Requirements for importing medical devices
Comment
During the covid-19 pandemic, various provisions regarding the import and marketing of medical-related equipment were either issued or amended. After more than a year of emergency provisions and exceptions being issued by the Mexican health authorities, it appears that there is finally a greater degree of legal certainty as to the general requirements for importing or marketing medical devices that may or may not have a direct connection with the pandemic.
As a general rule, the specific regulations or requirements depend on the nature and characteristics of the products and their tariff classification number.
General requirements for importing products
The following general requirements must be met when importing any kind of product:
- a tax ID must be obtained;
- the importer must register with the General Importers Registry and the individual sector registries, where necessary; and
- an authorised customs broker must be appointed to carry out the customs clearance procedure for the goods.
Requirements for importing medical devices
Various additional requirements must be met in order to import medical devices. These may be considered to fall within the general scope of the so-called "non-tariff requirements". As a general rule, all medical devices must have a marketing authorisation (MA), issued by the health authorities, prior to their import into and marketing in Mexico.
During the first stages of the covid-19 pandemic, various emergency MAs were issued to products that were considered to be essential (eg, respirators, face masks and oxygen tanks and the parts and components thereof). Many of these products have now obtained a final MA and are subject to the general import requirements of medical devices in Classes I to III.
As such, individuals and legal entities that import medical devices into Mexico must meet the general requirements, as well as the tariff and non-tariff requirements applicable to these kinds of goods.
Tariff requirements
From the tariff requirements perspective, import operations may be subject to:
- import duties;
- dumping duties;
- countervailing duties;
- value-added tax (VAT);
- excise taxes;
- governmental fees; and
- customs processing fees.
Most of these taxes, duties and fees are based on the goods' tariff classification under the Mexican Tariff Schedule and their applicable tariff classification number. Import, dumping and countervailing duties are also determined based on the country of origin of the goods, which is determined based on factors including the goods' specific tariff classification, place of production and manufacturing procedures.
In general, duties and taxes on import are determined based on the goods' customs value. The customs value of the goods includes not only the price paid for their acquisition but also other costs, including:
- brokerage fees;
- transportation;
- insurance;
- storing;
- handling;
- loading; and
- unloading costs.
Medical devices are generally covered by the tariff schedule subheadings 9018.19 and 9018.31 and are subject to import duties no greater than 10% of their customs value. Likewise, preferential duties may also be established where products originate from countries with which Mexico has entered into free-trade agreements.
Import procedures involving medical devices trigger a customs processing fee payable at the general rate of 0.8% of the product's customs value. This is generally not payable where products originate from countries with which Mexico has entered into free-trade agreements and which duly meet the applicable rules of origin.
In addition to the above duties, VAT is payable upon the import of medical devices into Mexico at the general 16% rate. Some exceptions to this tax are available; however, the goods that are subject to such exceptions are very limited.
Excise taxes, which are based on the applicable rate for each product under its nature and tariff classification, are generally not applicable to goods considered to be medical devices (except for some kinds of alcohol).
Non-tariff requirements
In addition to the general and tariff requirements, the import of medical devices is subject to a considerable number of non-tariff requirements, which are determined based on their tariff classification number and their purpose or use.
The most relevant non-tariff restrictions currently in place in Mexico include:
- import and export permits and licences;
- import and export quotas;
- practical restrictions for the international trade of goods subject to political interests (eg, agricultural, steel, textiles or tobacco); and
- Mexican Official Standards.
Medical devices generally require various import permits, licences or MA evidence, except where they are considered to be exempt under specific lists issued by the Mexican authorities.
In some cases, medical devices may also be subject to labelling requirements on their importation into Mexico during the customs clearance procedure. It may therefore be necessary to import such devices with an applicable Mexican label. The due compliance with such labelling requirements may be set out together with the MA authorisation by the health authorities.
In addition to the import process, the following activities are also subject to a considerable number of specific provisions for medical devices:
- warehousing;
- transportation;
- publicity; and
- marketing.
Therefore, individuals or entities that manufacture or sell goods which can be considered to be medical devices and that wish to enter the Mexican market should be aware of the requirements associated with importing and marketing such goods to avoid potential risks relating to the applicable restrictions.
For further information on this topic please contact José Alberto Campos Vargas at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.