Mexico is a growing market for medical devices, and medical device manufacturers are increasingly looking to register their products in this country. There are two main device registration pathways in Mexico: the Standard Review Pathway and the Expedited Registration Pathways.
Standard Review Pathway
The Standard Review Pathway is the most common pathway and is required for all medical devices, unless they are eligible for an expedited pathway. The Standard Review Pathway involves a comprehensive review of the device's technical documentation by COFEPRIS, the Mexican Federal Commission for the Protection against Sanitary Risks.
The Standard Review Pathway involves the following steps:
Classification of the device: The first step is to classify the device according to COFEPRIS's risk classification system. Medical devices are classified into three categories: Class I (low risk), Class II (medium risk), and Class III (high risk). Classify your medical device. Medical devices in Mexico are classified into four classes, based on their risk level:
Class I: Low-risk devices, such as bandages and tongue depressors.
Class II: Medium-risk devices, such as blood pressure monitors and surgical instruments.
Class III: High-risk devices, such as pacemakers and artificial heart valves.
Class IV: In vitro diagnostic devices, such as pregnancy tests and blood glucose meters.
Once you have classified your device, you will need to determine the appropriate registration route.
Preparation of the registration dossier: Once the device has been classified, the manufacturer must prepare a registration dossier. The dossier must contain all of the technical documentation required by COFEPRIS, including information on the device's design, manufacturing process, and quality management system, a detailed description of your device, clinical trial data, risk assessment.
Submission of the registration dossier: The registration dossier must be submitted to COFEPRIS electronically. COFEPRIS will review the dossier to ensure that it contains all of the required information and may request additional information. Once your dossier is approved, you will be issued a registration certificate.
Technical review: If the dossier is complete, COFEPRIS will begin a technical review of the device. The technical review will assess the safety and efficacy of the device.
Decision: Once the technical review is complete, COFEPRIS will make a decision on whether or not to approve the device for registration.
The Standard Review Pathway can take anywhere from 12 to 18 months to complete. However, the actual review time may vary depending on the complexity of the device and the workload of COFEPRIS.
Expedited Registration Pathways
There are two expedited registration pathways in Mexico:
Equivalency Review Pathway: This pathway is available for medical devices that have already been approved by a regulatory authority in the United States, Canada, or Japan. The Equivalency Review Pathway involves a less comprehensive review of the device's technical documentation by COFEPRIS, and can result in a faster registration time.
Third-Party Reviewer Pathway: This pathway is available for medical devices that are deemed to be low-risk by COFEPRIS. The Third-Party Reviewer Pathway involves a review of the device's technical documentation by an independent third-party reviewer.
Equivalency Review Pathway
The Equivalency Review Pathway is available for medical devices that have already been approved by a regulatory authority in the United States, Canada, or Japan. COFEPRIS recognizes the high standards of these regulatory authorities, and therefore, the Equivalency Review Pathway is a faster and more streamlined process than the Standard Review Pathway. The Equivalency Review Pathway typically takes 6-12 months to complete, which is significantly faster than the Standard Review Pathway.
To be eligible for the Equivalency Review Pathway, your device must meet the following criteria:
The device must be approved by the US FDA, Health Canada, or PMDA within the past five years. The manufacturer must also submit a copy of the approval certificate from the relevant regulatory authority.
The device must be classified as the same risk class in Mexico as it is in the country of approval.
The device must be manufactured in the same way as it is in the country of approval.
If your device meets all of these criteria, you can submit a simplified registration application to COFEPRIS. COFEPRIS will review your application and may request additional information. Once your application is approved, you will be issued a registration certificate.
Third-Party Reviewer Pathway
The Third-Party Reviewer Pathway is available for medical devices that are deemed to be low-risk by COFEPRIS. To be eligible for the Third-Party Reviewer Pathway, the device must meet the following criteria:
The device must be Class I or Class II.
The device must be manufactured using established technologies
The device must not be a life-sustaining or life-saving device.
The device must not be a device that is implanted in the body.
The device must have been approved by a regulatory authority in another country with a similar regulatory system to Mexico.
To register a device through the Third-Party Reviewer Pathway, the manufacturer must submit the device's technical documentation to an independent third-party reviewer. The third-party reviewer will review the documentation and issue a report. The report will be submitted to COFEPRIS, and if COFEPRIS agrees with the report, the device will be approved for registration.
If your device meets all of these criteria, you can submit your registration application to a third-party reviewer. The third-party reviewer will review your application and issue a technical report. If the technical report recommends approval, you can submit it to COFEPRIS. COFEPRIS will review the technical report and issue a registration certificate.
The Third-Party Reviewer Pathway is the fastest registration pathway, typically taking only 3-6 months to complete.
The following table summarizes the key differences between the Standard Review and Expedited Registration Pathways:
It is important to note that all medical devices, regardless of the registration pathway, must comply with COFEPRIS's regulatory requirements. This includes having a quality management system in place and meeting all applicable technical standards.
How to Choose the Right Pathway for Your Device
The best way to choose the right registration pathway for your device is to consult with a regulatory expert. They can help you to determine the eligibility of your device for each pathway and estimate the review time.
Generally speaking, the Standard Review Pathway is the most appropriate pathway for high-risk medical devices. The Expedited Registration Pathways are more appropriate for low-risk medical devices and medical devices that have already been approved by a regulatory authority in a country with a similar regulatory system to Mexico.
The Standard Review and Expedited Registration Pathways in Mexico offer different options for medical device manufacturers to register their devices. The best pathway for your device will depend on its risk classification and whether it has already been approved by a regulatory authority in another country.
If you are considering registering your medical device in Mexico, Artixio can help. We have a team of experts who can guide you through the registration process and ensure that your device meets all of COFEPRIS's requirements. Contact us today to learn more about our services.
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