We provide an overview of what to expect in 2025. Our team has curated the trends for 2025. We present insights on Market Intelligence, Medical Devices, Cosmetics, Dietary Supplements, Quality Affairs, Post-Market Surveillance, Logistics, and Advertising.

Interested in our last year's post? You can explore the 2024 trends here.

Anticipating a surge in approvals for 2025: Based on our expert analysis of COFEPRIS data, we predict an increase in medical device registrations in 2025. We observed a notable peak in approvals in 2024 (3,502), surpassing previous years with a 26.22% increase from 2023 (2,775) and a 108.91% increase from 2022 (1,682), and this upward trend is expected to continue. This projection is grounded in COFEPRIS’s recent efforts to streamline the registration process, such as the digital strategy for application submission, clearer guidelines, increased staffing, and training, reprioritizing reviews based on the application type, international harmonization, and proactive engagement with industry stakeholders to understand their needs and address challenges. Companies looking to enter or expand in the Mexican market should leverage this opportunity.
Plan Mexico’s impact: Plan Mexico aims to strengthen Mexico's medical device and pharmaceutical industries through incentives for local production, expanded public procurement, and the development of local suppliers to reduce import reliance. COFEPRIS will streamline regulatory processes through modernization and digitalization, speeding up approvals for imports and clinical trials. The plan also promotes R&D with financial incentives and strategic partnerships to advance generics, biosimilars, and innovative medical technologies, positioning Mexico as a key production and export hub in healthcare.
National Law for the Simplification and Digitalization of Procedures: The new law aims to replace the General Law on Regulatory Improvement, ushering in a new era of business-government interactions in Mexico starting in 2025. This law is designed to reduce administrative barriers by streamlining and digitizing processes. While the initiative was anticipated to be published on January 17, it remains pending.
Digital Transformation and Telecommunications Agency (ATDT): The newly created Agency is focused on streamlining and digitizing regulatory procedures to minimize paperwork and reduce processing times. This initiative is expected to accelerate approvals for new products and services, offering significant benefits to our clients by shortening the time to market. The agency will also roll out projects impacting COFEPRIS, customs, and health institutions, including implementing the Electronic Health Record.
LlaveMX: is a digital identity key that will allow citizens to access government services and conduct online transactions securely. Likely linked to users' CURP (Unique Population Registry Code), it will enable service authentication across various agencies, including COFEPRIS, customs, and other regulatory bodies. The platform aims to simplify processes, reduce bureaucracy, and enhance security. While details are still under development, LlaveMX is expected to be gradually rolled out, potentially integrating with platforms like COMPRANET for public procurement, with a launch target for 2025.
Mexico transitions to a Structured Procurement System: BIRMEX will centralize and restructure Mexico’s government procurement for medicines and medical devices through the new Consolidated Purchase Platform. This shift addresses the disorganized procurement issues under former President López Obrador, which led to shortages and inefficiencies. Under President Claudia Sheinbaum, the focus is on creating a more predictable and transparent system. By potentially expanding tenders to international suppliers beyond trade agreements, global manufacturers have new opportunities.

Continuity of the Regulatory Certainty Strategy for the Medical Devices Sector: The Strategy focuses on streamlining evaluations, adopting international standards, reclassifying devices by risk, and digitizing processes to reduce administrative burdens. It also aims to build regulatory capacity through global collaborations. However, uncertainty persists as the new COFEPRIS commissioner, Armida Zúñiga, has not clarified the implementation timeline or progress.
Telemedicine and connected technologies for medical devices: Portable devices such as wearables for health screening via data collection through health apps, remote monitors, or virtual medical consultation platforms will position Telemedicine as an effective alternative for personalized patient care.
Regulatory Updates: Although in previous years, the health authority in Mexico has made updates to FEUM 5.0 and the Regulation of Health Supplies, in 2025, we will see this trend continue in the process of updating complementary regulations such as the official Mexican standards focused on labeling, manufacturing, and distribution of medical devices, as well as post-market surveillance. However, regulations in Mexico will also face a significant challenge in encompassing the latest technologies and innovations in new medical devices.
Labeling update: In April 2024, COFEPRIS published the draft modification of NOM-137-SSA1-2008, which aims to define the labeling, proper use, and traceability requirements for medical devices for human use in Mexico. However, this draft remains under review and consultation, and no set date for its publication has been set. Therefore, it is necessary to stay informed about this update. Once published, it will take 180 days to come into effect.

Updates to Mexican Standard NOM-240-SSA1 "Installation and Operation of Post-Market Surveillance": In July 2024, the draft of the updated standard was published, opening a public consultation period. If approved, the final version will be published in the Diario Oficial de la Federación (DOF) and implemented 180 calendar days later. This standard will become enforceable as an Official Mexican Standard after this timeframe, expected to occur in 2025. The revised standard introduces new responsibilities for Registration Holders, distributors, and sub-distributors in Mexico, focusing on improving accountability and compliance in post-market surveillance activities.
Harmonization with International Standards: Mexico continues efforts to align its regulations with global standards, such as those established by the International Medical Device Regulators Forum (IMDRF). In 2025, COFEPRIS may implement further harmonization to improve global market access and compliance with international post-market surveillance requirements.

Self-Verification Guide: COFEPRIS will continue strengthening surveillance in health supply establishments to guarantee the population's safety. The recent publication of the "Self-Verification Guide" is a key tool in this strategy, as it establishes the regulatory framework for the inspection and traceability of supplies. This implies a greater responsibility for the establishments, which must comply with strict standards to avoid sanctions.
Updates for the new edition of the Mexican Pharmacopeia Supplement for establishments dedicated to selling and supplying medicines and other health supplies: The update could be published in the second quarter of 2025 and will take effect 60 days later. Some of the updates will directly impact the storage and distribution of medical devices.

AI and Automation for Efficient Supply Chains: AI will play a crucial role in optimizing logistics through demand prediction, route optimization, and task automation, such as order management and inventory control. These innovations will improve the efficiency of transporting medical supplies to public and private sectors while reducing costs and delivery delays.
Nearshoring and Mexico as a Regional Hub: The ongoing nearshoring trend, driven by geopolitical shifts and supply chain risks, will strengthen Mexico’s role as a key logistics hub. Medical device, cosmetics, and dietary supplement manufacturers will benefit from faster delivery to regional markets and growing foreign investment in local production and distribution networks.
Surge in Health Supply Exports: The rise of domestic production of health-related goods, including medical devices and pharmaceuticals, will boost Mexico’s exports. This growth will create heightened demand for specialized logistics services, particularly in global markets, and position Mexico as a critical player in the international health supply chain.
Faster Imports for Public Sector Needs: The recent regulatory agreement to expedite COFEPRIS import permits for public sector health supplies will enhance the flow of critical products, reducing bureaucratic bottlenecks and meeting the increased procurement needs under BIRMEX. This will further streamline logistics operations for global suppliers targeting Mexico’s public health sector. However, critics argue that by bypassing Mexico’s rigorous safety and efficacy evaluations, substandard products may enter the market, repeating past mistakes.

Adapting to innovation: As new ingredients and technologies emerge, COFEPRIS will need to update regulations to ensure the safety and efficacy of these products.
The rise of adaptogens: Innovation in food supplements is currently characterized by including adaptogens in their formulations to enhance their benefits. Regulatory improvements are expected for this industry whose estimated value was 10.3 billion dollars in 2024, with a compound annual growth projection of 7% until 2028.
Expansion of the FDA listing for allergens: On January 6, 2025, the FDA's allergen list was expanded to include macadamia nuts, hazelnuts, almonds, pistachios, and cashews. This update affects the declaration of dietary supplement ingredients on U.S. products. In Mexico, it is important to know this modification due to its possible effects on the regulation of dietary supplements.

Personalization: Cosmetics will be adapted to each person's individual needs. Skin analysis tools and algorithms will be used to offer personalized products and routines.
Technology: Augmented reality and artificial intelligence will be integrated into the shopping experience and product application.
Sustainability in beauty is no longer optional: The beauty industry will harness the power of AI-driven personalization, biotech ingredients, and closed-loop recycling systems to deliver high-performance products with a minimal environmental footprint. Consumers are demanding transparency and traceability, pushing brands to adopt blockchain technology to verify the sustainability of their supply chains.
Self-Verification Guide for Cosmetics Stablishments: COFEPRIS aims to reinforce regulatory compliance within cosmetic establishments and provide information that helps the industry understand the importance of the regulatory authority in the cosmetics sector. By following the guide, companies can understand the requirements to avoid sanctions and help strengthen the industry's regulatory oversight. The document, published at the end of December 2024, describes the regulatory framework for manufacturing, transporting, storing, and distributing cosmetic products.

Integration of advanced technologies for personalization: The adoption of mobile applications and data analysis allows companies to offer personalized shopping experiences. Based on a deep understanding of consumer needs and preferences, this strategy drives loyalty and optimizes the offer of products and services.
TikTok Shop: TikTok plans to launch a TikTok shop in Mexico. This platform will join Amazon and Mercado Libre as e-commerce platforms. Being a widely used influencer platform, it may be regulated in terms of advertising, depending on the type of information and products to be marketed. We’ve identified that cosmetic and dietary supplement companies are using this platform in other markets, and given the uncertainty that the platform faces in the USA, we can expect them to look into Mexico as a viable market to sell their products.
Strengthening of COFEPRIS: COFEPRIS is expected to continue strengthening its surveillance and control mechanisms, with special attention to misleading advertising of products that impact public health, such as food, beverages, dietary supplements, and medications. This translates into possible updates to the General Health Law and its Regulations on advertising.

At IPS, we are dedicated to helping our clients navigate these shifting dynamics with expert guidance and strategic insights. Stay informed and gain a competitive advantage by reading our upcoming publications. Contact us to learn more about our 2025 solutions. Learn more in our corporate video below.