Medical device registration in Mexico
In Mexico, medical devices and In-Vitro Diagnostic (IVD) devices are governed by COFEPRIS, a division within the Mexican Ministry of Health (Secretaría de Salud).
Medical devices are categorized into four different classes depending on their risk:
Medical devices are categorized into four different classes depending on their risk:
Low Risk
Class I
Class II
Class III
In addition to the listed documents, submissions must include product labels printed in Spanish. These labels must include the following information:
In addition to the listed documents, submissions must include product labels printed in Spanish. These labels must include the following information:
Product name, intended use, and catalog number.
Statement of sterility (if applicable).
Space for registration number.
Manufacturer and distributor names and addresses.
Salud approvals take approximately one to six months to obtain. These registrations are permanent and do not need to be renewed.
How to register for your medical devicein Mexico
Manufacturers are required to submit the following documentation to obtain registration approval:
Instructions for Use
Description of the manufacturing process
Information on materials, parts, and functions, and the description of the device’s structure
Certificate of Good Manufacturing Practices (GMP)
Application review fees:
Class I MD/IVD: $650 USD
Class II MD/IVD: $1 000 USD
Class III MD/IVD: $1 250 USD
Application review fees:
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
