Industry Trends 2026
We provide an overview of what to expect in 2026. Our team has curated the trends for this year. 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 2025 trends here.
Health sovereignty: The federal government has reiterated its intention to strengthen the national industry and reduce dependence on imported critical supplies. This vision aligns with the "Plan México," which aims to boost national health industries through local production incentives and the development of strategic industrial capabilities.
LlaveMX: LlaveMX is consolidating as the access gateway to the Mexican State's digital identity ecosystem. It is a unique, free, and secure account that allows for the authentication of individuals across multiple federal government platforms, eliminating user fragmentation and the use of multiple credentials. Its objective is to enable a digital identity that allows for completing procedures, requesting services, and accessing social programs across all three levels of government. In the short term, the integration of the "Digital File" for legal entities is expected, which will centralize corporate procedures, services, and documentation. In the health sector, this evolution can transform administrative digitalization from a simple bureaucratic improvement into a functional entry barrier to the public market.
Direct award to manufacturers as the new public procurement standard: The Mexican government is promoting an intermediary-free acquisition model for the consolidated purchase of medicines and medical supplies, prioritizing direct awards to manufacturers. This shift redefines the rules of the high-volume market, where production, logistical, and financial capacity becomes the primary competitive differentiator. The strategy mainly favors large corporations and established national manufacturers capable of meeting BIRMEX's operational requirements, while simultaneously raising entry barriers, shifting greater operational and financial risks to suppliers, and increasing the system's dependence on BIRMEX's actual execution capacity.
Abbreviated Regulatory Pathway: COFEPRIS is strengthening a regulatory scheme that reduces local technical evaluation and relies on approvals granted by reference authorities such as the FDA, EMA, WHO, and IMDRF. Accelerated market access applies only to identical products with current ordinary authorizations, representing a clear competitive advantage for portfolios already approved in mature markets.
Consolidation of the "reliance" or mutual trust model. This mechanism allows COFEPRIS to recognize the decisions of other high-level regulatory agencies to expedite the entry of innovative technologies into the Mexican market.
This abbreviated pathway is a priority for 2026, as the authority seeks to accelerate access to medical devices for the benefit of the population. The trend is to move away from redundant technical evaluation processes when the device has already been reviewed by agencies such as the FDA or EMA, focusing Cofepris's resources on high-risk products or local innovations.
The implementation of the infrastructure for this pathway is currently underway; we expect that during the first half of 2026, the abbreviated pathway will be consolidated and achieve its objective.
Lifecycle of Sanitary Registrations: With the recent reform to Article 376 of the General Health Law, a fundamental shift in the lifecycle of sanitary registrations in Mexico has been observed. Previously, renewal processes occurred every five years; however, the new framework establishes that, after an initial five-year validity period, registrations may be extended for periods of up to ten years. This action should not be interpreted as a relaxation of oversight, but rather as a shift in focus toward proactive post-market surveillance.
Under the new scheme, any change to raw materials, manufacturing sites, or product specifications that is not duly notified and authorized will be grounds for immediate cancellation of the registration through simplified administrative procedures. This mechanism compels manufacturers and registration holders to strengthen their change management systems and regulatory affairs departments to avoid supply chain disruptions.
Software as a Medical Device (SaMD): COFEPRIS has formalized that software performing diagnostic or clinical support functions must undergo a rigorous sanitary registration process, regardless of whether it is hosted in the cloud or runs on local devices. The integration of Artificial Intelligence (AI) into these systems has led to the creation of specific technical guidelines regarding Machine Learning and the control of changes in algorithms that evolve over time. Developers must now submit predetermined change control plans to ensure that the device's efficacy and safety do not degrade following algorithmic updates.
Administrative simplification and digitalization: With the publication of the procedures simplification agreements, as well as the implementation of equivalence agreements and the reliance mechanism with international agencies such as the U.S. FDA, Health Canada, and European agencies, evaluation times for medical devices are expected to be significantly reduced. The digitalization of procedures through the DIGIPRiS platform will allow for the conversion of multiple administrative codes into unified formats, facilitating traceability and eliminating the need for duplicated physical paperwork.
Update to NOM-240-SSA1: Although the update to NOM-240-SSA1-2012, "Installation and Operation of Post-Market Surveillance", is not expected to be published this year (2026), as the authority has concentrated resources on other priority regulatory projects, the modification project remains in progress following its public consultation. The objective is to modernize and strengthen post-market surveillance requirements for medical devices.
This update proposes expanding the responsibilities of registration holders, distributors, and sub-distributors, focusing on incident reporting and trend analysis to improve patient and user safety.
Launch of the Pharmacovigilance and Post-Market Surveillance bulletin by COFEPRIS: COFEPRIS has begun the periodic publication of specific Pharmacovigilance and Post-Market Surveillance notices and bulletins aimed at the industry and the general public. These contain relevant information on incident notifications, sanitary alerts, and health surveillance actions. These bulletins seek to foster a more active and transparent reporting culture, strengthen communication between the authority, registration holders, and distributors, and improve the detection of safety signals linked to medical devices.
This initiative increases the visibility of safety incidents and alerts, which could lead to increased information requests, audits, or preventive actions. Preparing now will allow companies to reduce regulatory risks, strengthen their relationship with the authority, and ensure the continuity of their operations in the Mexican market during 2026.
NOM-241-SSA1-2025 update: The update to this standard came into effect in late 2025, replacing the 2021 version and representing a near-total alignment with the international standard ISO 13485:2016.
Current regulations require all establishments involved in the design, manufacturing, storage, and distribution of medical devices to implement a robust Quality Management System (QMS).
For devices manufactured abroad, compliance with NOM-241 rests with the sanitary registration holder in Mexico. This implies that the legal representative in Mexico for medical devices must possess documentary evidence that the foreign manufacturing site complies with Mexican GMP (Good Manufacturing Practices) or recognized equivalents, such as the MDSAP certificate. Furthermore, the standard mandates precise guidelines regarding over-labeling and storage conditions to minimize the risk of errors within the supply chain.
Reliance: The new regulatory framework for medical device GMP: The adoption of the regulatory reliance ecosystem, through the formal recognition of MDSAP, establishes a new framework for compliance with Good Manufacturing Practices for medical devices in Mexico as of 2026. This approach eliminates the duplication of audits between MDSAP and national verifications under NOM-241-SSA1-2025, streamlining the demonstration of Quality Management System compliance, reducing time-to-market, and improving product availability. In addition, it may strengthen the incorporation of high-technology medical equipment and encourage investment in the national production chain, aligning with strategic objectives of the Plan México, such as promoting domestic manufacturing, pharmaceutical and medical device production, and increasing national content in public procurement.
Likewise, the Reliance model delivers significant reductions in operational and logistical costs by minimizing redundant inspections, thereby optimizing financial and human resources. The harmonization of national GMP standards with international benchmarks such as ISO 13485 and MDSAP facilitates global expansion and international trade, while the modernization of regulatory oversight, through remote inspections and a risk-based approach, enhances regulatory efficiency. Overall, this framework sets a precedent for closer collaboration among global health authorities and strengthens the quality and safety of medical devices in a cost-effective manner.
Reform of the Customs Law and strengthening of operational control: The reform of the Customs Law, in effect as of January 1st, establishes a stricter framework for the control and oversight of foreign trade operations, reinforcing importer obligations regarding traceability and documentary support, including the Electronic Value Declaration (MVE). This update aims to strengthen the fight against undervaluation and technical smuggling. For the industry, the impact is reflected in more frequent documentary reviews, an increase in audits, and a broader liability scheme that falls on both the importer and the customs broker, raising compliance requirements for customs operations.
Artificial Intelligence as an enabler of logistical efficiency: In 2026, Artificial Intelligence has consolidated as a key operational tool in logistics and supply chain management, allowing for more precise planning and proactive management of inventories, demand, and risks. Through predictive data analysis, AI facilitates the anticipation of delays, operational failures, and market variations, reducing logistical costs and operational errors. Likewise, the automation of administrative and repetitive processes optimizes human capital usage and improves overall operational efficiency.
Tariff changes in the LIGIE: Modifications to the Law of General Import and Export Taxes (LIGIE) continue to be an active trade policy tool, with tariff adjustments applicable to products considered strategic. These changes respond to the need to regulate import flows, protect specific sectors of the national industry, and address international trade dynamics. For companies, updates to the LIGIE directly impact import costs and the planning of foreign trade operations.
USMCA (T-MEC): Review and validity of the trade Agreement: The review of the United States-Mexico-Canada Agreement (USMCA) scheduled for 2026 remains highly relevant due to its role as the central framework for regional trade and the integration of North American supply chains. This process responds to the need to evaluate its application and validity in the face of economic, production, and commercial changes in the region. For companies operating under the USMCA, this review is significant due to its impact on operational planning, documentary compliance, and the continuity of associated tariff preferences.
Nearshoring and reconfiguration of supply chains: Nearshoring remains a relevant trend heading into 2026, stemming from the reconfiguration of supply chains and the search for greater operational resilience against geopolitical, logistical, and commercial risks. Mexico continues to position itself as a strategic point due to its proximity to the United States and its commercial integration with North America, driving the relocation of production and logistical operations. This context increases pressure on infrastructure, customs processes, and regulatory compliance, making it necessary to strengthen logistical and operational capabilities to handle a higher volume and complexity of operations.
E-commerce as a driver of modern logistics: E-commerce continues to directly influence the evolution of logistics toward 2026, redefining expectations for delivery times, shipment visibility, and operational flexibility. This model drives companies to strengthen their logistical capabilities by integrating more agile processes, real-time tracking systems, and greater operational control. For the industry, e-commerce represents a commercial expansion opportunity, provided there is a logistical operation aligned with an environment of higher demand and efficiency.
Centralization of medical supply through BIRMEX: The Mexican government's strategy foresees BIRMEX assuming a central role in the procurement and distribution of medicines and health supplies by 2030, as part of a centralized purchase and supply model for the public sector. This approach seeks to reorganize the medical supply chain and address historical challenges in production, storage, and distribution. For the industry, this trend is relevant due to its impact on the structure of the public market, procurement schemes, and the logistical capabilities required to participate in institutional supply.
Adapting to Innovation: As new ingredients and technologies emerge, COFEPRIS will need to update regulations to ensure the safety and efficacy of these products.
Gen Z and Millennials: Selective and informed consumers: These generations will place greater importance on functional nutrition, beauty and aesthetics, longevity, and mental health as preventive tools. Since these generations have greater access to information, companies must consider that every claim included on their labeling must be backed by the necessary scientific foundations.
Self-Verification Guide for Dietary Supplements: During the September 2025 EDUCAPRIS session regarding classification inquiries for dietary supplements, the publication of a self-verification guide for the classification of these products was mentioned as support material for the industry. To date, it has not been published; therefore, it is expected to be available for consultation this year.
Global Ingredients of interest for 2026:Innovation in dietary supplements is increasingly driven by consumer interest in holistic wellness, which includes beauty, cognitive performance, and digestive health. Some of these trends are:
Beauty from within:
Hyaluronic Acid in dietary supplements to aid skin health.
Astaxanthin, with antioxidant benefits focused on skin, nails, and hair.
Glutathione, a group of amino acids increasingly present in Asian products. Cited benefits include improvements to skin, nails, and hair.
Nootropics:
Rhodiola rosea: A traditional adaptogen that supports stress resilience, with evidence of benefits for cognitive performance, energy levels, and mood.
Bacopa monnieri: An Ayurvedic plant associated with brain health, contributing to memory, focus, and overall cognitive function.
Lion’s mane mushroom: A functional mushroom with clinical support for its potential to enhance cognitive function and support mood.
Digestive Health
The use of prebiotics, probiotics and postbiotics aimed at generating consumer well-being.
The use of new ingredients will represent a regulatory challenge due to the current scope of Mexican regulations, requiring companies to develop and implement robust regulatory strategies that enable them to anticipate requirements, manage approval pathways, and ensure compliance.
AI-Driven personalization: Artificial Intelligence (AI) and Augmented Reality (AR) are consolidating in 2026 as essential tools for mass personalization. In the Mexican market, brands will implement skin diagnostic applications focused on biomarker analysis using smartphone cameras, allowing for the formulation of tailor-made products that respond to the unique genetic and environmental needs of each individual.
More than 75% of young consumers in Mexico value personalization as the decisive factor for choosing a product. This is driving the development of personalized cosmetics that dynamically adjust to weather conditions or the user's stress level.
New General Law on the Circular Economy: By 2026, sustainability is no longer viewed as a voluntary choice but as a regulatory obligation in Mexico. The enactment of the General Law on the Circular Economy represents a fundamental shift in how companies in the cosmetics industry approach packaging design and waste management. The primary objective of this legislation is to minimize waste generation and promote more efficient use of materials by prioritizing reduction, reuse, repair, and recycling strategies.
Innovation in packaging and biodegradable formulas: In 2026, the industry will move towards a redesign of its products, based on the new legal provisions. Considering new formats such as:
Solid and concentrated formats: Shampoos, conditioners, and cleansers in bar or stick form that eliminate the need for complex plastic packaging and reduce water consumption.
Refill Systems: Refill stations at points of sale and reusable packaging that promote consumer co-responsibility.
Compostable and biodegradable materials: Use of plant-based resins and packaging that leaves no toxic residue at the end of its useful life.
Low water footprint formulations: Development of anhydrous (waterless) products that optimize logistics and reduce environmental impact during transport.
AI involvement in commerce: Beyond AI applications in logistics and inventory management, it is becoming a link between the consumer and the product for consultation purposes, such as product and price comparisons, as well as obtaining recommendations.
Social media as advertising media: The influence of social networks (such as TikTok) on purchasing decisions for newer generations is confirmed. This highlights the importance of collaborating with content creators, building digital communities, and leveraging social media recommendations.
Omnichannel: Digital and physical presence: Nowadays an e-commerce strategy is fundamental but it's not yet time to forget about physical presence. According to statistics, 61% of consumers (aged 18 to 70) were influenced by social media at the time of purchase. Regarding preferred channels, Amazon and Mercado Libre stand out as the top choices.
In terms of purchasing channel preferences by age:
18 to 35: Digital media predominates.
36 to 50: They utilize both online shopping and physical stores.
51 to 70: They prefer traditional channels, such as physical stores, where they can receive personalized service.
Live Shopping: This e-commerce strategy has positioned itself as a high-potential dynamic for companies, as it merges entertainment with real-time audience interaction through social media platforms like TikTok. Through content creators, it is possible to showcase products, resolve doubts, and close sales live, creating an innovative shopping experience.
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 solutions. Learn more in our corporate video below.
