News Details

The Chilean Institute of Public Health (ISP) has launched a public consultation on a proposed set of guidelines aimed at clarifying the classification of products under sanitary control. The new guidelines, which will define how products such as pharmaceuticals, cosmetics, medical devices, pesticides, disinfectants, and food products are regulated, are designed to strengthen public health protection while offering clearer regulatory guidance to industry stakeholders.

The proposal, entitled Guía de Consideraciones para la Correcta Clasificación de Productos Sometidos a Control Sanitario (Guide for the Correct Classification of Products Under Sanitary Control), is now open for public feedback. The ISP encourages manufacturers, importers, distributors, health professionals, and the general public to review and provide their input on the guidelines, which will play a crucial role in shaping the future of health product regulation in Chile.

Purpose of the Consultation

The public consultation process aims to gather diverse perspectives on the proposed criteria for classifying regulated products, ensuring the final guidelines are comprehensive, clear, and well-informed. The guidelines address product categories such as medical devices, cosmetics, food additives, and pharmaceuticals, with the goal of ensuring these products meet the necessary health and safety standards before reaching the market.

The ISP emphasizes that a clear and effective classification system will help prevent the circulation of unregistered or improperly labeled products, which could pose risks to public health. The guidelines are intended to provide regulatory certainty for businesses and protect consumers by ensuring products are appropriately categorized based on their composition, intended use, and mode of action.

Key Aspects of the Proposed Guidelines

Among the significant elements of the proposed guidelines is the detailed explanation of "borderline products"—items that fall into ambiguous categories, often straddling between medicines, cosmetics, and medical devices. These products are difficult to classify due to their hybrid nature, and the guidelines provide guidance on how to determine their regulatory status.

The ISP proposes a set of criteria for determining which regulatory framework applies to such products, with a focus on safety, efficacy, and consumer protection. These classifications will be based on scientific evidence and the primary intended purpose of the product.

International Alignment

The proposed guidelines also highlight the importance of aligning Chile’s regulations with international standards, particularly those set by organizations like the World Health Organization (WHO), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA). The ISP aims to harmonize its classifications for pharmaceuticals, cosmetics, and medical devices with global norms, making it easier for businesses to comply with both local and international regulations.

For instance, the classification of sunscreen products is one area where international differences occur, with some countries categorizing them as medical devices, while others treat them as cosmetics. The ISP aims to provide clear direction on how to handle such discrepancies.

Advertising and Labeling

The proposed guidelines also place a strong emphasis on the advertising and labeling of health-related products. The ISP intends to implement regulations that prevent misleading claims, ensuring that products are marketed according to their correct classification. Only products that meet the criteria for pharmaceuticals, for example, will be allowed to make therapeutic claims, while cosmetics cannot be advertised as providing medical benefits.

Call for Public Feedback

The public consultation will be open until the 23rd of March 2026, during which the ISP welcomes comments, suggestions, and concerns from all sectors involved. Once the consultation period concludes, the ISP will review the feedback and finalize the guidelines, incorporating the most relevant points raised by stakeholders.

Next Steps

The ISP has committed to making the final guidelines publicly available after reviewing the feedback from the consultation.