Mexico is the second-largest market for medical devices in the LATAM region, next to Brazil, and is the import hub for Medical Devices in Latin America. The Medical devices marketed in Mexico are regulated by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), and the regulations are both stringent and complex.

The classification and grouping of medical devices is a prerequisite for selecting the right device registration pathway. Medical devices in Mexico are categorized as Class I (low risk), Class I, Class II, and Class III based on the health risks they pose to the end-user. The manufacturer, based on the classification and prior country approvals for the device, may opt for either the Standard Review Pathway or the expedited equivalency pathway. The devices approved by the United States Food and Drug Administration (FDA), Health Canada, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are eligible for expedited equivalency pathway. This method has been shown to reduce the review time of registration applications by up to five (05) months.

The devices that are not approved by the US FDA, Health Canada, or PMDA must opt for the standard review pathway. The manufacturer is required to submit a detailed, full-length technical dossier of the device for registration. The manufacturers applying through the standard review pathway may opt for the third-party reviewers for expedited assessment of the application and the product’s technical information.

The Third-Party Reviewer (TPR) allows a private, independent commercial, and an accredited organization in Mexico to do an initial review of an application. If all the information is submitted and is found satisfactory, the third-party provides a technical report recommending approval to COFEPRIS. While there is an additional fee for using a TPR, which varies with the entity the manufacturer chooses, COFEPRIS usually does not request any extra information regarding the application after the TPR has issued its report. The organization gets it reviewed from TPR which helps in faster approval with minimum risk involved. The TPRs are more responsive and assess applications more rapidly because they are commercial enterprises, resulting in a faster total review process. If there are no further requests for information after evaluating the report, COFEPRIS will issue the final registration certificate. This cuts down the standard review to a timeline of two to five (2 – 5) months.

The standard review pathway requires approval from the Country of Origin (COO) and an accredited quality system. Documentation requirements include technical data supporting the safety and efficacy of the device. The manufacturer shall submit the application form available on the COFEPRIS website along with the device information, including:

• Proof of payment
• MRH details
• Proof of home country approval
• Product technical information – material information, manufacturing process, test data, sterilization data, device shelf life and expiry date, stability data, clinical data (if applicable based on device class), labeling details (IFU, labels, etc.)

The documentary requirements for the standard review pathway would remain the same, whether the manufacturer opts for the third-party reviewer or not. The timelines for device registration with COFEPRIS vary from a month to a year, depending on the risk class and the sufficiency of the information provided by the manufacturer.  The Class I (low-risk) devices, with the least data requirement and fastest review process, may be approved in one to three (1 – 3) months, whereas the other risk classes, such as Class I, II, and III, usually take up to three to six (3 – 6) months. The timelines might increase up to ten to twelve (10 – 12) months, considering the COVID. These timelines exclude any supplementary requirements from COFEPRIS. The benefits of the standard pathway include faster review timelines for any post-submission queries.

With the availability of various pathways, the medical device manufacturer must weigh the business needs, overall registration cost for the Third-Party Reviewer (TPR), need for faster access to market, the device demand and potential market share the manufacturer can tap, Return of Investment (RoI) and break-even, among other factors to decide which one would suit their device.

Freyr offers end-to-end device registration services in Mexico, including any of the registration pathways, compiling technical documents, translation requirements, Mexican Registration Holder (MRH), and all the pre- and post-approval requirements.

For more information on the standard review pathway for medical device registration in Mexico, kindly reach out to a proven Regulatory expert today. Stay informed. Stay compliant.