In Mexico, all medical devices must be regulated by the Mexican Federal Commission for Protection against Sanitary Risk (COFEPRIS) to ensure their safety and efficacy. COFEPRIS is a federal agency that belongs to the Ministry of Health. The regulatory submission process for medical devices is overseen by the agency’s five principles and fifteen actions program.
Step 2: Appoint a Local Authorized Representative
A foreign manufacturer of medical devices must appoint an authorized representative in Mexico to interact with COFEPRIS and fulfill the local representation requirements. The representative must be a legal entity in Mexico and can be either a Mexican company or an individual.
The role of the local authorized representative is to serve as a liaison between the manufacturer and the Mexican authority and should be familiar with the regulations related to the medical device. The representative will also be the official contact for all communications with COFEPRIS tramites and the responsible party for the sanitary registration of the product in the country.
Step 3: Submit the Application
After preparing and submitting all required documentation, the application will be reviewed and evaluated by the agency. Depending on the classification of the device and the work load, this can take several months. The evaluation is based on the technical, clinical, and quality aspects of the device.
Once the application is approved, the company must fulfill the responsibilities established in the regulation and comply with all requirements outlined by COFEPRIS. This includes establishing a quality management system at the manufacturing facility, training employees on health standards and procedures, and reporting any incidents to the regulator.
In addition, the legal manufacturer must comply with all regulations related to good manufacturing practices and stability of the medical device in order to avoid product recalls. Finally, the legal manufacturer must maintain documentation of all activities at the manufacturing facility.
The sanitary registration of medical devices in Mexico is a complex and time-consuming procedure. To facilitate the process, it is important to have an experienced regulatory consultant that is well-versed in the rules and regulations of the agency and its specialized committees.
As the pandemic continues, it is critical that companies familiarize themselves with the different processes and regulations of COFEPRIS to ensure their products can be sold in the country as soon as possible. The article outlines the main steps of the process and what is needed in order to complete each one successfully.