Laryngoscopes are essential medical devices used in anesthesiology and airway management. While traditional laryngoscopes have been in use for many years, advancements in technology have led to the development of video laryngoscopes. These innovative devices involve additional considerations for their sanitary requirements in Mexico.
Types of Laryngoscopes
- Classic or Conventional Laryngoscopes: consist of a handle, blade, and light source.
- Reusable: Typically, non-sterile and require sterilization after each use.
- Single-use: Sterile and discarded after use.
- Video Laryngoscopes: Feature a built-in camera at the blade’s tip. The camera, with the assistance of the light source, transmits real-time video images to a connected display.
- Components:
- Reusable: Handles and/or displays.
- Single-use: Blades (various sizes and shapes).
- Components:
Classification in Mexico
Laryngoscopes are designed to facilitate visualization of the trachea for anesthesia or intubation. These devices are invasive but only used for brief periods (limited contact).
- Classification according to their intended use: laryngoscopes are classified as Type I Medical Equipment.
- Risk Profile Classification: Due to their potential risks, laryngoscopes fall under Class II.
Grouping in Mexico
- Conventional Laryngoscopes: The common presentations include:
- Single-piece: Handle and blade packaged together.
- Two-piece: Handle and blades sold separately.
- Kit: Handle with blades of various sizes and shapes, typically in a tray.
All these presentations can be included in a single registration as either a single device or grouped as a kit.
- Video Laryngoscopes: Typical presentations:
- Reusable and non-sterile: Handle and display or standalone display.
- Single-use and sterile: Blades in various sizes and shapes.
- Video laryngoscopes can be grouped into a single registration as a system based on the definition in Section 4.2 Grouping Criteria of the Supplement of Medical Devices:
“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.”
Additional Considerations
Laryngoscopes or video laryngoscopes with electrical components and batteries may be classified as Medical Electrical Equipment (MEE). This classification requires compliance with additional standards before importation and distribution in Mexico.
Conclusion
Understanding the proper classification and grouping of laryngoscopes and video laryngoscopes is critical to get approvals to import and distribute those products in Mexico. Please contact us at contact@veraqueconsulting.com for professional guidance on how to successfully bring those products to Mexican market.
