Mexico is currently the second largest medical device market in Latin America, the top importer of medical devices in Latin America, and one of the fastest growing markets worldwide. In Mexico, medical devices are regulated by the Federal Commission for Protection of Sanitary Risks (Comisión Federal para la Protección Contra Riesgos Sanitarios, or “COFEPRIS”), which is a division of the Secretariat of Health (Secretaría de Salud). COFEPRIS is a decentralized and autonomous body responsible for review, approval, and post-market monitoring of any healthcare product in Mexico, and is headed by a commissioner appointed by the president of Mexico.
Compared to many other countries, particularly in Latin America, Mexico has harmonized its medical device regulations to ensure that its health care system has access to the same state-of-the art technologies available in other parts of the world. Most of the medical devices sold in Mexico are imported, primarily from the US and Canada through preferential treatment under the North American Free Trade Agreement (“NAFTA”).
The legal framework for medical device regulation in Mexico is based on the General Health Law (Ley General de Salud), and Regulation of Health Supplies (Reglamento de Insumos para la Salud), which consists of mandatory (e.g. the Normas Oficiales Mexicanas, or “NOMS”) and voluntary standards (Norma Mexicana, or “NMXs”) and other agreements. An initial step when considering registering in Mexico is to determine whether your device is on the COFEPRIS list of deregulated devices. Currently over 2,000 items, such as standalone software, hospital beds, and wheelchairs, are among the listed products not requiring registration in order to be sold in Mexico.
For all other devices classification is based on the risk to patients and users, and includes three classes as well as a special low risk category:
- Class I Low Risk: these devices (e.g. face masks, cervical collars, bandages and other items often included in a medical device kit, or as a component or accessory) must be registered, but do not need to provide technical data to support registration. As with the other classes, Class I Low Risk products must comply with the labeling and post-market requirements for medical devices, and must also apply for registration through a Mexican distributor or Mexico Registration Holder (“MRH”);
- Class I: for products that are well-known to medical practice, whose safety and effectiveness are proven, and generally are not introduced into the body;
- Class II: products that are well-known to medical practice, may have differences in the material with which they are made or in their concentrations, and generally introduced into the body for less than 30 days;
- Class III: products that have only recently been accepted into medical practice, or when they are introduced into the body they remain there for more than 30 days.
As noted above, foreign manufacturers are not allowed to submit registration applications directly to COFEPRIS, and instead must appoint a Mexican distributor or MRH to act in that capacity. There are several alternative paths to registration, each of which involves submission of documents translated into Spanish and evaluation by a group of specialized reviewers.
1) Standard: the applicant submits materials and technical data supporting the safety and efficacy of the device. For this path the applicant must also show approval for the device in the manufacturer’s home market and proof of a certified quality system.
One advantage of the Standard path for registration is that devices originally registered this way have much faster review times for any subsequent administrative modifications (e.g. adding, deleting, or changing a distributor; changes to a company name or address for the manufacturer, distributor, or MRH; or rights transfer/ change in the MRH). Another significant advantage of the Standard path is that the registration will be eligible for Third Party Review.
2) Standard with Third Party Review: a Third Party Reviewer (“TPR”) is a private commercial entity authorized by COFEPRIS to conduct an initial review of an application and, if satisfied, write a technical report for COFEPRIS recommending approval. While there is an additional cost for using a TPR, typically no additional information will be required by COFEPRIS after the TPR issues its report. Also, since TPRs are commercial entities they tend to be more responsive and review applications more quickly, resulting in a shorter review process overall. After reviewing the report, if there are no further requests for information COFEPRIS will issue the final registration certificate.
3) US FDA Equivalence: A Class I, II, or III device approved by FDA for sale in the US can apply for registration in Mexico without submitting the extensive technical information required for the Standard path to registration. However, the applicant will need to provide a) an FDA-issued Certificate to Foreign Government (“CFG”) certifying that the device has been cleared or approved for sale in the US; b) a history of all adverse events; and (c) an FDA-issued Establishment Inspection Report (“EIR”) certifying compliance with FDA Quality System Regulations (“FDA QSR”). If an EIR is not available because the manufacturer has not yet been inspected for FDA QSR, or inspection has taken place but the EIR not yet issued, proof of ISO 13485 quality system certification may instead be accepted. Note also that at this time registrations using the FDA equivalence path are not eligible for review by a TPR.
Mexico is a growing market for medical devices, driven in part by the large numbers of expatriate Americans and Canadians who retire there. Understanding the registration system for medical devices is an important part of assessing the potential opportunity in this expanding market.