Obtaining a sanitary registration in Mexico is mandatory for marketing a medical device in the country. Typically, each device requires its own registration based on factors such as the manufacturer, intended use, technology, and materials. However, in some cases, multiple devices can be grouped under a single registration as a system, a regulatory strategy that improves efficiency and approval timelines.
With increasing numbers of medical devices meeting the definition of a system, understanding Mexico’s grouping criteria is essential. In this article, we explore the regulatory definition, compare it with other regions, and provide practical examples to illustrate how manufacturers can apply this approach.
What Defines a Medical Device System?
While Mexico’s regulatory framework is influenced by international standards, the grouping criteria for medical device systems have specific nuances. Let’s examine how different regions define a system:
- European Union (MDR Definition)
A system refers to a combination of products (packaged together or separately) intended to be interconnected or combined to achieve a specific medical purpose.
- Canada (Medical Devices Regulations)
A system is a medical device comprising multiple components designed to be used together to fulfill some or all of its intended functions, sold under a single name.
- Mexico’s Definition (Mexican Pharmacopeia Supplement, Section 4.2)
“Supplies that are packaged together or not, intended to be interconnected or combined for the purpose of achieving a specific medical purpose, and that have the same indication for use, when used for the same medical procedure or otherwise justified in the system, may be registered as a system.”
Practical Examples: How to Apply Mexico’s System Criteria
To determine if your medical device qualifies as a system, ask these key questions:
- What are the system’s components?
- What is the indication for use?
- Are the components packaged together?
- Are they interconnected or combined to achieve a medical purpose?
- Is there additional justification for grouping them?
Example 1: Videolaryngoscope System
- Components: Handles, blades, displays, cables
- Indication: Facilitates tracheal visualization for intubation/anesthesia
- Packaged together? No
- Interconnected? Yes
- Justification: Exclusive use; all components are essential
Example 2: Knee Joint Replacement System
- Components: Plates, screws, femoral/tibial/patellar implants
- Indication: Restores knee joint function
- Packaged together? No
- Interconnected? Yes (implanted as a unit)
- Justification: Same medical procedure
Example 3: Patient Monitoring System
- Components: Monitor, cables, sensors, tubes
- Indication: Tracks patient vital signs
- Packaged together? Yes
- Interconnected? Yes
- Justification: same manufacturer
Example 4: Dental Scanner System
- Components: Handpiece, cables, monitor, software
- Indication: Creates digital dental models
- Packaged together? Yes
- Interconnected? Yes
- Justification: Software is of use exclusive with the system
Conclusion
Many medical devices in the market meet the criteria for system grouping, allowing manufacturers to streamline registrations, reduce costs, and accelerate market entry. By carefully assessing your device’s components, intended use, and interconnections, you can determine whether a single system registration is feasible.
Need help evaluating your medical device for Mexican sanitary registration? Contact Veraque for expert regulatory guidance.
