IPSNEWS
Dietary Supplements, Herbal Remedies, and Medicines: Key differences in their regulation.
In the Mexican regulatory landscape, the classification of products intended for health or well-being is fundamental. In the market, we can find options such as dietary supplements, herbal remedies, and medicines, all of which possess specific characteristics, a defined purpose of use, and, most importantly, a clearly differentiated regulatory framework.
Tariff Classification as a compliance tool
Tariff classification is, without a doubt, the most important step for any foreign trade operation. It represents the standard code that allows customs to unequivocally identify the merchandise and, based on it, apply the entire regulatory framework.
Korea Sourcing Week Case Study / Caso de Estudio
The Korea SMEs and Startups Agency (KOSME), a key government entity, sought to bridge the gap between innovative Korean cosmetic manufacturers and the lucrative Mexican market. They partnered with Insumos para la Salud (IPS) to facilitate meaningful connections at the Korea Sourcing event.
Key considerations for Cosmetic and Dietary Supplement claims in Mexico
Mexican regulations establish fundamental principles governing claims for cosmetic products and dietary supplements. The main objective is to ensure that these products are safe, effective, and not misleading to consumers.
Keys to International Trade: EUR.1 and USMCA Certificates for Mexico
In foreign trade, competitiveness and operational efficiency largely depend on effective document management. Among the most important documents is the certificate of origin, which certifies the country where a product was manufactured and, in Mexico’s case, is essential for obtaining tariff reductions or exemptions under free trade agreements.
Big Changes at COFEPRIS! Mexico Simplifies Medical Device Registration and Advertising Notice
Mexico's regulatory authority, COFEPRIS, has introduced a landmark agreement to modernize its regulatory processes. For medical devices, multiple submission categories for new registrations and renewals are now consolidated into a single, unified procedure. This reform streamlines submissions and shortens review timelines considerably. Additionally, the agreement introduces updated requirements for advertising notices.
COFEPRIS Implements Agreement to Streamline Import and Export Permits
On August 11, 2025, the Agreement establishing actions for the simplification of procedures before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) was published in the Official Gazette of the Federation (DOF).
COFEPRIS Enables Regulatory Reliance Through Abbreviated Pathway
On July 18, 2025, COFEPRIS published the Agreement outlining the General Guidelines for the application of the Abbreviated Regulatory Pathway for granting sanitary licenses for medical devices and drugs.
Unlocking Efficiency: COFEPRIS Modernizes Regulatory Framework
On July 11, 2025, COFEPRIS published a landmark Agreement in the Official Gazette of the Federation, marking a decisive step toward the nationwide simplification and modernization of sanitary procedures.
Keys to the Labeling of Dietary Supplements in Mexico
Dietary supplements are defined as products intended to increase or complement the total dietary intake, or to supply one or more of their components. COFEPRIS is the authority in Mexico responsible for regulating these products and for establishing the labeling requirements they must meet to be marketed in the country.