Mexico Fast-Tracks Medical Device Approval
For medical device and in-vitro diagnostic (IVD) tool manufacturers that previously were unwilling or unable to market their products in Mexico, it may be time to reconsider. COFEPRIS (the Federal Commission for Protection Against Sanitary Risks), the Mexican Health Authority’s regulatory arm overseeing medical devices, recently implemented an equivalence agreement allowing products already cleared and commercialized for sale by the U.S. Food and Drug Administration (FDA) or Canada’s Health Canada (HC) to be sold in Mexico without meeting any additional substantial regulatory requirements. In other words, it just got a lot easier for medical device makers to sell their wares south of the U.S. border.
While COFEPRIS’s move presents a significant and clearly positive development for medical device and IVD manufacturers, it will require more than just a passport to fully take advantage of new opportunities in Mexico. Nonetheless, manufacturers that already have gone to great efforts to gain product clearance from U.S. or Canadian regulators (or both) now have access to an additional market heavily reliant on imports and with a population of much more than 112 million people—Latin America’s second-largest market behind Brazil—as sort of a bonus.
Having gone into effect Nov. 25 last year, the equivalence agreement is intended to provide Mexican citizens with expedited access to medical devices already evaluated by the FDA and HC; the safety standards of the United States and Canada already have been recognized as equivalent to Mexico’s General Health Law, prompting COFEPRIS to accept authorization by the country’s northern neighbors as adequate proof of safety. Furthermore, Mexican authorities expect the move will allow regulators to dedicate more staff and resources to issues concerning domestic medical device manufacturers.
Equivalence Details
General open-door policy sounds good, but what specific requirements of the new COFEPRIS agreement will medical device makers need to address in order to market their products in Mexico?
Devices classified as Class I, II and III and cleared by the FDA as well as Class II, III and IV devices approved by HC qualify for automatic approval by Mexican authorities. All manufacturers must submit detailed summaries of their products; COFEPRIS also has set up more specific requirements for FDA-cleared and HC-approved devices, respectively.
For FDA-cleared products, COFEPRIS requirements depend on how the FDA has classified a particular device. A Class I product maker will have to present a Certificate to Foreign Government (CFG), the product’s most recent inspection report as well as an FDA report describing the product’s classification. Class II and III device makers must provide the afore-mentioned documentation as well as summaries of their products’ post-market surveillance histories.
Manufacturers of Class II, III and IV products cleared by HC must provide an HC Medical Device License, an ISO 13485 Canadian Medical Devices Conformity Assessment Scheme and a document proving HC product approval. Products commercialized under HC’s Class I category, however, will not qualify for the equivalency agreement and will have to go through the standard COFEPRIS regulatory approval process. FDA Class I devices, on the other hand, may qualify for the agreement’s provisions. Furthermore, the agreement applies only to medical devices—pharmaceuticals must continue to follow standard regulatory approval processes in Mexico.
According to COFEPRIS, even though the equivalency agreement went into effect in November, it may take up to six months for the regulator to respond to the initial batch of submissions following the announcement. That timeframe should shrink to 30 days once COFEPRIS gets used to the new regulatory process.
Simpler Path to Market
How effective COFEPRIS’s equivalence policy proves in attracting more manufacturers to the Mexican medical device market largely depends on whether manufacturers find that policy significantly simpler than the country’s standard approval process.
Mexico’s conventional path to regulatory approval first entails determining a device’s proper classification—Class I, II or III according to risk level—using “Criteria for Medical Device Classification” rules, and then confirming that classification using a list of product codes maintained by COFEPRIS. The device already must have been approved for sale in its country oforigin and have a CFG from the FDA.
Following determination of classification, the manufacturer must provide proof of compliance with a national quality system standard such as an ISO 13485 certificate or FDA Good Manufacturing Practice. Then, Class I and II device makers must prepare registration dossiers containing relevant submission documents—unless their devices already havegained FDA or Health Canada approval, in which case their dossier requirementsautomatically are met—as well as technical information, applicable testing results and labeling information. Clinical data and biocompatibility testing are required for Class III devices, but COFEPRIS typically will accept clinical data and testing from foreign sources.
Manufactures of devices with 510(k) clearance or premarket approval from the FDA as well as those granted licenses from HC and commercialized in the United States or Canada now have been granted fast-track review status. Device labeling requirements including translation into Spanish still have to be met, and foreign companies apparently must still appoint local representatives to serve as liaisons with COFEPRIS. In addition, classification and grouping families still are necessary in the new process. For example, a device belonging to an FDA Class I group family is not necessarily considered a Mexican Class I group family—it could belong to a Class II group, or it may be necessary to split the device’s group family into more than one registration. If a product’s classification in Mexico is indeed different, this only has implications for the cost of the manufacturer’s submission.
End Result: More interest?
Mexico’s new equivalence arrangement does not exactly constitute effortless entry into its medical device market with no regulatory strings attached. As of this writing, much remains to be ironed out in terms of the new arrangement’s details. But COFEPRIS’s latest move clearly simplifies many significant aspects of the country’s medical device approval process.
Whether or not Mexico’s new policy attracts more device manufacturers to its market, however, remains to be seen given how recently that new policy was announced. But prior to the policy change, Mexico wasn’t necessarily high on the list of new markets manufacturers had targeted for entry.
According to responses in Emergo Group’s latest medical device industry survey conducted in late 2010, interest in Mexico among many respondents fell well behind markets such as China and Brazil. Nearly 45 percent of participants saw only low growth potential in Mexico, while 23 percent of participants rated the market as high-growth. In terms of level of difficulty complying with Mexican medical device regulations, nearly 32 percent of respondents rated the country neutral and another 30 percent said they didn’t know enough about the market.
Company size and location also may determine interest in Mexican market entry: More than 11 percent of small-tier medical device firms indicated plans to enter Mexico for the first time in 2011, while less than 6 percent of large-tier firms expressed such plans.
Geography also seemed to provide a good predictor of where interest in Mexico will come from in 2011. More than 17 percent of Asian medical device firms and nearly 12 percent of European firms plan to enter Mexico this year; only 8 percent of North American firms plan to do so, but many of the survey’s North American respondents already may have set up shop in that market.
Results of that survey were being compiled at the same time that COFEPRIS’s new policy came about, so it’s hard to say if the equivalence agreement had any effect on respondents’ answers—or if their plans regarding Mexico have changed now that they’ve had time to digest the new policy. But given this market’s size and import-oriented nature, combined with its newly simplified approval process, it’s difficult to see how continuing to make Mexico a second-tier priority makes good business sense any longer.
Miguel Torres Tello is responsible for supervising technical information and proper documentation management of registration submissions for Emergo Group in Mexico. He maintains close contact with medical device manufacturers during different stages of the registration process, from the classification of their products to the final submission of their registration with COFEPRIS, a division of the Mexican Health Ministry.