Category Archives: Sanitary Registration of Products

New Technical Regulation on Hemp and Derivative Products in Costa Rica

On February 20, 2025, La Gaceta published Technical Regulation RTCR 511:2023, which establishes guidelines for sanitary products containing hemp and its derivatives. This regulation sets requirements for importation, manufacturing, and sanitary registration, covering products such as food, dietary supplements, cosmetics, pesticides, medical equipment, and more. A key aspect of the regulation is the control of…

New Regulation Streamlines the Entry of Raw Materials for Free Trade Zones into Costa Rica

The Ministry of Foreign Trade and the Ministry of Health have issued regulations under Decree No. 44696-S-COMEX, allowing the admission of products of sanitary interest or their raw materials into the free trade zone and active improvement regimes without requiring sanitary registration or authorization notification, considering the following: The products of sanitary interest or their…

New Regulation for the Authorization of Health Products in Free Trade Zones Enters Public Consultation

The Costa Rican Ministry of Foreign Trade and the Ministry of Health have issued a regulation, which is currently under public consultation, to authorize the entry into the free zone regime of products of sanitary interest or their raw materials without the need to process a sanitary registration or notification when such products meet the…

New structure and modifications for the sanitary registration of prepackaged foods in Guatemala

The Ministry of Health of Guatemala will implement a series of changes in the procedure and requirements for the sanitary registration of prepackaged foods, starting August 5, 2024, following the entry into force of the Central American Technical Regulation 67.01.31:20 Processed Foods. Procedure For the Granting, Renewal, and Modification Of Sanitary Registration.  The new regulation…

New expiration date for EMB sanitary registry

The sanitary registrations of Biomedical Equipment and Material (EMB), Chemical Synthesis Medicines, Biological medicines, Medicines with Therapeutic Equivalence, Hygienic Products, and Natural Products that expire between April 2023 and November 2023 will have their expiration extended to February 29, 2023. 2024.

New requirements and procedures for the classification, registration, import, labeling, advertising, and surveillance of biomedical equipment and material

On September 9, 2023, the new RTCR 505: 2022: BIOMEDICAL EQUIPMENT AND MATERIAL. CLASSIFICATION, REGISTRATION, IMPORT, LABELING, ADVERTISING, SURVEILLANCE, AND CONTROL came into effect, establishing requirements and procedures for the classification, registration, import, labeling, advertising, and surveillance of biomedical equipment and material. Under this new regulation, the following documents, which were not previously requested by…

Authorization for the import of raw materials with CBD in Costa Rica

Those natural or legal persons who wish to import raw materials with CBD and manufacture hemp-derived products in Costa Rica must apply to the Ministry of Health for authorization to manufacture hemp derivatives or hemp products of health interest under the provisions in law 10113 Law on Cannabis for Medicinal and Therapeutic Use and Hemp…

Nutrient Warning Seals on Food Labeling

The Sanitary Records Unit of the Ministry of Health of Costa Rica issued the circular MS-DRPIS-UR-1588-2023 on June 22, 2023, indicating that when a product presents frontal labeling with the following stamps or images, it will be mandatory for the importer or distributor to hide said information from the original label, so that the information…

Nicaragua bans the importation of electronic cigarettes

On September 6, the General Directorate of Customs Services issued the technical circular identified as CT/116/2022, informing the officials of the General Directorate of Customs Services and the public of the prohibition on the importation of electronic cigarettes and the obligation of importers and exporters of tobacco to register before the National Sanitary Regulation Authority….

Guatemala joins the information bank for the regional evaluation of medicines

On August 2, 2022, the Ministry of Public Health and Social Assistance announced adhesion to the regional mechanism for the joint evaluation of dossiers of medicines and related products for human consumption. With this adherence, the health regulatory authorities in charge of endorsing drug registrations in El Salvador, Honduras, Nicaragua, Costa Rica, Panama, and Guatemala…