With Mexico's presidential election approaching, COFEPRIS sets its sights on the road ahead. This post unpacks the agency's key priorities for the rest of the six-year term, along with a spotlight on upcoming events.

COFEPRIS 2024 Agenda and Industry Trends

COFEPRIS, Mexico's regulatory agency, has outlined its agenda for the remainder of its six-year term, which concludes in September 2024. Key priorities include:

Strengthening Regulatory Oversight: COFEPRIS aims to enhance regulatory oversight to ensure the safety, efficacy, and quality of health products and services in Mexico. This includes implementing robust monitoring and inspection protocols to enforce compliance with regulatory standards.
Promoting Innovation: Efforts will focus on streamlining approval processes for new health products and technologies to expedite market access.
Improving Market Surveillance: COFEPRIS seeks to strengthen market surveillance activities to detect and address potential risks associated with health products and services. This involves conducting regular product safety assessments, performance, and post-market surveillance measures.
Enhancing Regulatory Processes: COFEPRIS aims to optimize regulatory processes to facilitate timely approvals and reduce administrative burdens. This includes simplifying registration procedures, advancing their digital strategy, and promoting transparency in regulatory decision-making.
Collaborating with Stakeholders: The agency recognizes the importance of collaboration with industry stakeholders, healthcare professionals, and regulatory authorities to achieve regulatory objectives. Collaboration efforts will focus on fostering dialogue, sharing best practices, and addressing emerging challenges in the healthcare sector.

In October 2024, a new commissioner is expected to lead COFEPRIS. This leadership change presents challenges and opportunities for stakeholders in the healthcare industry.

As Mexico goes through this critical transition period, IPS will remain vigilant, engaging proactively with key stakeholders and adapting strategies to potential changes to guide our clients to navigate the evolving landscape and continue contributing to healthcare advancement in Mexico.

Reclassification of Medical Devices: COFEPRIS, through the Mexican Pharmacopoeia, is implementing a new risk-based classification system for medical devices. This system categorizes devices into four categories: i) Low risk, ii) Low to moderate risk, iii) Moderate to high risk, and iv) High risk. The new classification system is expected to reduce evaluation times, ensure that criteria and requirements are based on risk, and allow low-risk devices to be registered through a notification process without requiring complete evaluation.
Harmonization and regulatory improvement: Anticipate revisions to the existing labeling regulation NOM-137-SSA1-2008 by June, which could eliminate technical obstacles to trade due to differences in labeling rules. In addition, the Health Supplies Regulation (RIS) could be updated by March.
Streamlined Digital Processes: Further improvements in COFEPRIS's online platforms are expected to facilitate faster application submissions and potentially shorter review times. Modifications to sanitary registrations are expected to be added to the DIGIPRIS platform by September.
Faster Resolution Times: COFEPRIS intends to improve reviewers' skills, leading to shorter processing times for applications and approvals and benefiting businesses and consumers. According to their 2024 agenda, it plans to authorize 450 new registrations from January to September. It also intends to close the gap with modifications for faster approval times. In addition, based on our experience, during a presidential election year, COFEPRIS often prioritizes evaluations, likely intending to achieve higher approval numbers.
Reliance mechanisms: COFEPRIS will continue to conduct an in-depth evaluation of the technical requirements that it will recognize from the authorizations issued by other regulatory agencies, which could positively impact the Equivalency Agreements.

Harmonization and regulatory improvement: By March, anticipate revisions to the existing post-market surveillance (PMS) regulation NOM-240-SSA1-2012. According to the Regulatory Certainty Strategy for Medical Devices published in October last year, COFEPRIS said it would issue it in the previous quarter of 2023.
Stakeholder Engagement and Education in PMS: We should expect increased awareness campaigns to educate healthcare professionals, manufacturers, distributors, registration holders, and patients about their roles and responsibilities in PMS activities. COFEPRIS has PMS training sessions planned throughout the year in their annual training program.

Harmonization and regulatory improvement: In November of 2023, COFEPRIS became an MDSAP affiliate member. Such accomplishment contributes to revising the USMCA agreement since the recognition of MDSAP is part of the binding commitments of the Medical Devices Sector Annex. Anticipate revisions to the existing good manufacturing practices regulation NOM-241 to include MDSAP by September and the MDSAP audit recognition for manufacturers in Mexico.
Compliance with NOM-241-SSA1-2021: The challenge for the industry is maintaining a functional and continuously improving quality management system that aligns with guidelines set by the health authority. The fifth version of the Medical Device Supplement introduced new provisions, emphasizing risk management across the product life cycle and its integration into quality management systems.
Internal Audits and Training: We expect both medical device manufacturers and distributors to work on continuously improving their quality management systems by providing regular internal audits and employee training to ensure ongoing compliance with NOM-241-SSA1-2021 and other regulations.
Distributor compliance: Since last year, we have seen more interest from medical device distributors in wanting to comply with the new standard, particularly with section nineteen, which focuses on good storage and distribution practices to ensure consistent product quality.

Nearshoring and reshoring: The trend of companies shifting production closer to consumer markets, particularly from Asia to Mexico, is expected to continue, boosting demand for logistics services within the country. This will pressure warehouse space and cold chain infrastructure, potentially leading to higher costs.
Backlogs and delays: While COFEPRIS aims to improve efficiency, some delays and backlogs in import permit processing are anticipated due to increased workload. Knowing if your product requires an import permit is paramount to factor in the review time in your commercial strategy.
AIFA's Operational Hurdles: Despite its potential to alleviate pressure on Mexico City's Benito Juárez International Airport (AICM), Aeropuerto Felipe Ángeles’s -(AIFA) relatively young customs operation continues to pose business challenges due to infrastructure limitations, limited experience and manpower, distance and transportation issues and unfamiliar procedures.

Stricter Advertising Guidelines: Expect the advertising guide for influencers for greater control of the products advertised on social networks. This could impact influencer marketing strategies.
Enhanced Product Monitoring: Increased surveillance of deceptive products and misleading advertising will likely lead to more product recalls and fines. Manufacturers must prioritize product safety, truthful marketing, and compliance with advertising regulations to avoid penalties.
Adoption of DIGIPRIS: The self-managed procedures platform (DIGIPRIS) presents an opportunity for advertising notices. It is still unclear when COFEPRIS will add advertising permits will be added to the platform.

Rise in Health Alerts: Expect an increase in COFEPRIS surveillance, which will trigger health alerts due to regulatory non-compliance, particularly in online sales. Also, consumers are becoming more aware of safety issues and will likely report non-compliant products, categorized as “miracle-deceptive products.” Companies need to prioritize robust quality control and compliance measures.
Evolving Consumer Preferences: Growing demand for natural and organic products will continue as consumers prioritize health and wellness. Manufacturers need to adapt their offerings to cater to these evolving preferences.

Enforced Manufacturing Standards: COFEPRIS will publish guidelines for the new manufacturing standards for cosmetics NOM-259 that will raise the bar for quality and safety. Companies need to ensure compliance with these new regulations to remain competitive.
Evolving Consumer Preferences: Growing demand for natural and organic products will continue as consumers prioritize health and wellness. Manufacturers need to adapt their offerings to cater to these evolving preferences.
Greater surveillance: Products manufactured in Mexico and abroad should expect more surveillance. Companies need to prioritize robust quality control and compliance measures.