There are many medical device manufacturers that are currently operating in Mexico. Some of these firms are globally recognized companies such as Medtronic, Boston Scientific, St. Judes Medical, Becton Dickinson and CR Bard. Others are lesser known medium-sized device producers. These companies ship the bulk of their product back to the United States. However, companies that are contemplating the possibility of beginning future manufacture of devices and products used in the area of healthcare should be aware of the fact, that, after Brazil, the Mexican medical device market is the second largest in Latin America.
In order to sell product into the medical device market, it should be known that manufacturers are required to register their product, or products, with Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios, or COFEPRIS. COFEPRIS a regulatory body that operates under the umbrella of the Mexican Secretariat of Health. In addition to approving items for sale and use in the Mexican medical device market, the entity also has authority over issues related to pharmaceuticals, food safety some environmental matters, as well as regulatory discretion in matters having to do with organ transplants.
Although there are some differences in the steps required to have products approved for dispensation into the Mexican medical device market, when compared to those needed to gain admission into the markets of other countries, as of January of 2011 COFEPRIS implemented rules for equivalency between itself and the FDA in the United States and Health Canada. Under the arrangement with the FDA, US manufacturers are eligible to submit all Class I, II and III medical devices for Mexican approval. According to Emergo, a medical device consultancy based in Austin, Texas, for equivalent treatment, US companies must provide COFEPRIS with a(n):
- Establishment Inspection Report (EIR)
- Certificate to Foreign Government (CFG)
- History of adverse effects of Class I,II and III medical devices
- Proof of listing, clearance and approval
Additionally, as a result of the rules implemented at the beginning of 2011, Emergo notes that Canadian companies are eligible to make application for entry of Class II, III and IV products into the Mexican medical device market. Canadian Class I devices are not eligible to petition for COFEPRIS approval. According to Emergo for equivalent treatment, for the applicable classes of medical devices eligible for approval, Canadian companies must provide COFEPRIS with a(n):
- Medical device license
- ISO 13485 certificate
- ISO 17021 certificate of registrar
- Standards Council of Canada Accreditation
In great part, the steps required to the approval of a product into the Mexican medical device market are akin to the rules that are in place in the European Union. COFEPRIS is the Mexican agency which classifies devices and establishes the time lines during which approval will be considered and granted. It is very important to know that this process can occur in a period of days numbering from one-hundred and twenty to a full calendar year. All documents required by Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios during the conduct of the approval process must be submitted in the Spanish language. The United Trade Administration has published an excellent on-line guide that provides in in-depth explanation as to how to navigate the Mexican system as it relates to gaining approval a product into the Mexican medical device market, as well as having it duly registered by the appropriate regulatory authorities. This information is updated as
of June 11, 2011.
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