Regulatory compliance for the commercialization of regulated products in Central America

Sandra Ortiz

Sandra Ortiz

Regulatory compliance for the commercialization of products in Central America involves a series of regulations and requirements established by the countries of the region with the objective of guaranteeing the safety, quality and legality of the products that are made available to the market. Each country has its specific regulations, but there are some general regulations that are important to consider:

    1. Sanitary Registration: Most health-related products, such as drugs, medical devices, food products and cosmetics, generally require sanitary registration in each Central American country where they are marketed. This involves submitting documentation demonstrating the safety and efficacy of the product, as well as complying with quality, safety and good manufacturing practice standards.
    2. Technical standards and labeling: Products must comply with the specific technical and labeling standards of each country. This includes requirements such as clear and legible information in the local language, list of ingredients, expiration date, instructions for use and warnings.
    3. CE marking: For some products, especially medical devices and electronic products, it is important to comply with international standards, such as the CE marking (conformité européene), which is accepted in some Central American countries as an indication of compliance with safety, environmental protection and quality standards.
    4. Customs requirements: It is important to know the customs requirements for importing and exporting products in the region. This includes customs documentation, tariffs and specific import requirements.
    5. Quality certifications: In some cases, it is necessary to obtain specific quality certifications for certain products, such as ISO 9001 for quality management systems or ISO 13485 for medical devices.
    6. Compliance with local regulations: Each country in Central America may have additional local regulations that must be complied with. It is critical to research and understand these market-specific regulations.
    7. Intellectual Property Protection: If your product is protected by intellectual property rights, such as patents or trademarks, make sure that these rights are protected and respected in each country where you plan to market your products.
    8. Safety regulations: In addition to product-specific regulations, it is also essential to comply with safety regulations in the marketing, storage and transportation of products, especially those that may pose health or environmental risks.

It is important to note that regulations and requirements may vary from one country to another, so it is recommended to be updated and in tune with the governmental institutions and foreign trade authorities of each country who can provide updated information on the specific regulations in force.

Mutual recognition of sanitary registration of food and beverages

Currently, to support the economic and commercial integration of Central America and to simplify procedures for sanitary registration, for the first time an electronic system has been implemented to facilitate the mutual recognition (rm) of sanitary registrations of food and beverages. This procedure accepts the registration of a product that has been registered in another state but is part of the Central American region so that it can be marketed in its territory with the original registration number.

It is a friendly system, and the procedure is simple and understandable, as well as an important tool to become competitive. It represents a transcendental step in the modernization of sanitary registrations, which allows for an agile and expeditious process, also minimizing operational costs.

It is important to highlight that, through this system, since its implementation until May 2023, a total of 54,453 recognitions have been granted at regional level, of which 47% were granted by Guatemala, 34% by Costa Rica, 10% by El Salvador, 6% by Honduras and 3% by Nicaragua.