The landscape of the Mexican medical device market is characterized not only by a surge in technological advancements and innovation, but also for its regulatory entry barriers. Therefore, to guarantee transparency and efficiency, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has devised a Regulatory Certainty Strategy for the Medical Device Sector that seeks to remedy various regulatory and operational impediments that negatively affect access to safe and high-quality medical technologies.
In this article we will delve into the meaning and challenges of Regulatory Certainty in Mexico, as well as the actions COFEPRIS is taking to ensure and promote it along the Mexican regulatory framework.
Context: Why is the Regulatory Certainty necessary?
Nowadays, the Mexican market of medical devises distinguishes itself by its competitiveness and significant productive capacity, being recognized in the global market for its manufacturing and assembly processes. It has specific characteristics, such as:
- A wide array of products. They range in complexity from surgical materials to devices to perform a Computerized Axial Tomography, or Software as a Medical Device powered by Artificial Intelligence.
- An increasing R&D pace of new products from academic institutions or private enterprises.
- Arising challenges in technological and digital fronts, guided by adaptability and innovation.
Recent events such as the COVID-19 pandemic underscored the importance of international cooperation to address common health issues more efficiently. It is crucial not only for dealing with emergencies but also for tackling situations of backlog related to the limited resources available to regulatory authorities.
Globally, there exists coordinated efforts to establish guidelines facilitating the adaptation of policies that ensure the supply and safety of medical technologies. The International Medical Device Regulators Forum (IMDRF) stands out as the most relevant initiative in this regard.
Definition of Regulatory Certainty
COFEPRIS defines Regulatory Certainty as:
- The full compliance with the regulatory framework for the protection against health risks.
- To provide clarity to the user in:
- the authorization requirements and their definition,
- the internal evaluation process, and
- the time associated with each of the stages of the evaluation process.
- Ensure a standardized evaluation based on technical-scientific criteria.
- Effective recognition of the decisions of regulatory authorities in other jurisdictions.
- To guarantee regulatory harmonization with internationally valid standards to favor industrial development, access to new medical treatments and competitiveness.
- The guarantee of instances of regulator-regulated interaction free of corruption and conflicts of interest, favoring good governance.
- The commitment that the regulatory changes to be implemented have a vision of improvement, harmonization and regulatory innovation that guarantees a stable regulatory ecosystem, with governance mechanisms, adequate implementation times and a long-term vision.
- The transparency of information through public diffusion of regulatory fundaments and performance data, allowing the betterment of the regulatory system with the commitment of continuous improvement.
Activities for the Strengthening of Capacities
Several enterprises have been put in motion to strengthen COFEPRIS’ regulatory and responsive capacities, ensuring that Regulatory Certainty is being taken into consideration. Some of the activities are:
Medical Devices Regulatory Convergence Project (MDRC).
The Medical Devices Regulatory Convergence Project for COVID-19 (MDRC) aims to promote the use of international standards for regulatory purposes of medical devices, enhancing the predictability of regulatory ecosystems through alignment with international standards. It identifies regulatory convergence through the exchange of information, training, and training resources. It also aims to expand capacity-building efforts, increase the adoption of international standards, save patients’ lives, reduce non-tariff barriers, and improve public administration and transparency.
The MDRC recognizes the utilization of international regulatory best practices recommended by the OECD, WTO, and WHO, as well as adherence to the guidelines of the IMDRF and the use of the Medical Device Single Audit Program (MDSAP). Additionally, it serves as a valuable tool to support regulatory convergence.
Pan American Health Organization (PAHO).
At the regional level, COFEPRIS is a participant in the Regional Working Group on Medical Device Regulation, coordinated by PAHO. This strengthens the regulatory capacities of regulatory authorities through meetings, cooperation initiatives, an adverse events exchange program, alert systems, IMDRF mirror groups, among other activities.
World Trade Organization (WTO).
For medical devices, as with all products subject to health regulation under the jurisdiction of COFEPRIS, it strives to comply with the rules of the WTO, particularly as outlined in the Agreement on Technical Barriers to Trade. Mexico implements these rules through the Agreement published on December 30, 1994, and in the exercise of the best regulatory practices.
In order to enact the Regulatory Certainty, some measures are being planned, with some of them already being put into action. These measures include:
a) Establishment of the Good Regulatory Practices Committee
As part of the Regulatory Certainty Strategy for the Medical Devices Sector 2023-2026, COFEPRIS envisions the creation of a Good Regulatory Practices Committee (C-BPR) with the aim of ensuring that all changes in the regulatory framework are coherent and viable. The committee, dependent on the Scientific Committee, has the following responsibilities:
- Develop executive work plans for the proper implementation of regulatory modifications, harmonized, improved, and administratively simplified.
- Monitor and support the implementation of regulations with change management and training actions, both within technical teams and in regulated sectors, to ensure an effective adoption process of the new regulatory framework.
- Generate impact assessment mechanisms before and after changes to the regulatory framework.
b) Authorizations for Medical Devices through Recognition of Decisions by Regulatory Authorities of Other Jurisdictions
To strengthen the execution of COFEPRIS’ responsibilities, promoting better use of available resources and enriching regulatory decision-making, they aim to restore institutional provisions on the use and recognition of information, reports, and decisions issued by other regulatory agencies, initiatives, forums, and international organizations.
In terms of medical devices, the guidelines of the International Medical Device Regulators Forum (IMDRF), including tools like the Medical Device Single Audit Program (MDSAP), international standards issued by the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), recommendations from the World Health Organization (WHO) and the Pan American Health Organization (OPS), as well as guidelines derived from international agreements and treaties such as the United States-Mexico-Canada Agreement (USMCA) or the Pacific Alliance (PA), are the main references for international regulatory best practices considered in this project.
c) Regulatory Harmonization
To achieve regulatory convergence for medical devices, COFEPRIS will use documents produced by the International Medical Device Regulators Forum (IMDRF) as a reference for updating the regulatory framework. Results from the Medical Device Single Audit Program (MDSAP) and ISO 13485 will also be considered for Good Manufacturing Practices Certification. To strengthen this effort, COFEPRIS will actively and continuously participate in the IMDRF working groups and biannual sessions to achieve Observer Member status, in compliance with the forum’s requirements. In the same vein, COFEPRIS aims to achieve Affiliate Member status in MDSAP by 2024, once the established requirements are met. To accomplish this, COFEPRIS commits to referencing international regulatory trends synthesized by this forum in the local regulatory framework.
d) Reclassification of Medical Devices
As we explained in our Ultimate Guide for Regulatory Affairs, Mexico currently has a classification system for medical devices divided into three categories: Class I, Class II and Class III. While this classification has allowed for a proper risk-based evaluation of these health supplies, it is currently outdated compared to some international provisions. This complicates regulatory harmonization or the understanding of regulatory provisions for newly established companies in the country.
To address this, COFEPRIS, through the Mexican Pharmacopeia, issued relevant provisions to achieve a classification harmonized with international recommendations. The new classification will migrate to four categories:
- Low risk
- Low to moderate risk
- Moderate to high risk
- High risk.
This classification will bring new benefits, such as:
- Appropriate evaluation times for each type of product
- Criteria and requirements based on risk
- The lowest risk category to function as a notification to the health agency, as these products do not require evaluation due to the low probabilities of causing harm to health.
COFEPRIS projects that the new classification will be formalized in the first quarter of 2024 through the modification of the Health Supplies Regulation.
e) Digitalization as a Path to Optimization
As a general strategy for digitalization to optimize regulatory processes, comply with established legal timelines, and address backlog, the health authority is tackling the issue through two avenues:
- Self-management processes: Creation of processes with automatic responses.
- Remote evaluation through virtual means: expanding scope in exploration, with a direct impact on reducing timelines.
In 2022, COFEPRIS released the first functionalities of the digital platform, including the electronic evaluation of the first extension for medical devices and the issuance of automatic resolutions for subsequent extensions of the same devices. Additionally, throughout 2022, COFEPRIS enabled self-managed digital processes (such as operation notices, health responsibility notices, and advertising notices).
The next functionality in digitalization is the release of the platform for Modifications to the Registration Conditions of Medical Devices, expected in the first quarter of 2024.
In the pursuit of the Regulatory Certainty, COFEPRIS has undertaken strategic initiatives and collaborations that underscore its commitment for a stable and adaptive regulatory ecosystem. Change in management, updating the national regulatory framework, and engagement in various mechanisms and forums for harmonization serve as an example of a proactive approach.