What Is The Medical Device Classification Mexico Utilizes?

Expanding your business into Mexico offers a strategic advantage, especially for companies in the medical industry as Tijuana is the Mecca for Medical Device manufacturing in Mexico. With its proximity to the United States, competitive costs, and highly skilled workforce, Tijuana has become a prime location for manufacturing and assembling medical devices. However, before entering the Mexican market, understanding the system of medical device classification in Mexico is essential.

This guide will explain the classification process, highlight the benefits of manufacturing in Tijuana, address potential challenges companies may face when entering the market, and show how Tijuana EDC can help your company overcome these obstacles and establish operations smoothly and efficiently.

What is Medical Device Classification in Mexico?

Medical devices in Mexico are regulated by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), a division of the Mexican Ministry of Health. COFEPRIS ensures that all medical devices meet safety and quality standards, not only for use in Mexico but also for export to international markets.

Since 1846, Mexico has had the Farmacopea, the only publication in the world specialized in medical devices. The medical device sector in Mexico is divided into six large groups based on their function and purpose of use:

1. Medical Equipment: Devices, accessories, and instruments intended for medical or surgical care, examination, diagnosis, treatment, rehabilitation, and biomedical research.
2. Prostheses, Orthoses, and Functional Aids: Devices designed to replace or complement a function, organ, or tissue of the human body.
3. Diagnostic Agents: Supplies such as antigens, antibodies, calibrators, verifiers, reagents, kits, culture media, and contrast media used to aid clinical and paraclinical procedures.
4. Dental Supplies: Substances and materials used for dental health care.
5. Surgical and Healing Materials: Devices and materials with or without antiseptics or germicides, used in surgical practice and for treating skin lesions.
6. Hygienic Products: Materials and substances applied to the skin or body cavities with pharmacological or preventive action.

Medical device classification Mexico is based on their level of risk to patients and users. Similar to the U.S. FDA and European CE classifications, Mexico’s system divides medical devices into three categories:

• Class I: Inputs known in medical practice with proven safety and efficacy that generally are not introduced into the body, such as bandages, surgical gloves, and thermometers.
• Class II: Inputs known in medical practice that may have material variations or concentration differences and generally remain in the body for less than thirty days, like catheters, infusion pumps, and diagnostic equipment.
• Class III: Inputs that are new or recently accepted in medical practice, or that remain in the body for more than thirty days, such as pacemakers, heart valves, and orthopedic implants.

Each classification determines the level of regulatory scrutiny and documentation required for approval. Companies must provide evidence of product safety, efficacy, and quality through clinical data, technical specifications, and compliance with Good Manufacturing Practices (GMP).

Why Choose Tijuana for Medical Device Manufacturing?

Tijuana has been a key player in the global manufacturing industry for over 30 years. The city is home to a thriving ecosystem of medical device companies that produce and assemble products for markets worldwide. Here are some of the key benefits of choosing Tijuana for your medical device manufacturing needs:

1. Strategic Location: Located just minutes from the U.S.-Mexico border, Tijuana offers easy access to major markets in the United States and beyond, reducing transportation costs and delivery times.
2. Skilled Workforce: Tijuana boasts a highly trained and experienced workforce with expertise in advanced manufacturing, including precision engineering and quality control.
3. Global Standards Compliance: Manufacturing facilities in Tijuana adhere to international safety and quality standards, including ISO 13485 certification for medical devices. This ensures that products meet regulatory requirements not only in Mexico but also in the United States, Europe, and other global markets.
4. Cost-Effective Operations: Lower labor and operational costs make Tijuana an attractive alternative to manufacturing in other countries without compromising on quality or compliance.
5. Robust Infrastructure: Tijuana offers modern industrial parks, advanced logistics networks, and reliable utilities, creating an optimal environment for manufacturing and exporting medical devices.

Potential Challenges and How Tijuana EDC Can Help

While expanding into the Mexican market offers numerous advantages, companies may face challenges such as navigating regulatory requirements, understanding local business practices, and ensuring compliance with both Mexican and international standards. Tijuana EDC is here to help businesses overcome these challenges by providing expert guidance and support.

Our free services include:

• Regulatory Navigation: We assist in understanding COFEPRIS regulations and aligning with U.S. FDA and European CE requirements, ensuring that your medical devices meet global standards.
• Legal Compliance: We clarify Mexico’s legal requirements, helping your company establish a compliant and efficient operation.
• Cultural and Business Integration: We offer insights into local business culture, labor regulations, and operational best practices.
• Government Liaison: We facilitate communication with local, state, and federal authorities to expedite approvals and permits.
• Ongoing Support: Our network of professionals and strategic alliances ensures that you receive expert assistance at every stage of your investment.

Understanding Mexico’s medical device classification system is crucial for companies looking to manufacture or assemble these types of products in the country. With its strategic location, skilled workforce, and commitment to global standards, Tijuana is the ideal destination for medical device manufacturing. Although entering a new market can present challenges, at Tijuana EDC we specialize in providing the expertise and support needed to overcome obstacles and establish successful operations.

Discover why Tijuana has become a game-changer for companies worldwide seeking to expand and optimize their operations while making a positive impact on the local community through job creation. With numerous global companies operating maquiladoras in Mexico, foreign investment in Mexico is a strategic choice, thanks to the Tijuana’s unique advantages and benefits outlined above.

Contact us today to evaluate your project’s viability and take the first step toward expanding your business in Tijuana. Our team of experts is ready to guide you through every stage of the process, from initial planning to full-scale production. Let Tijuana EDC be your trusted partner in achieving long-term success. If this article helped you, check out, How Are Medical Devices Classified in Mexico? Tijuana Can Help! Or How Are Medical Devices Regulated in Mexico? Tijuana Leads.