Mexico is possibly one of the most lucrative markets in Latin America, particularly for exporting medical devices. According to local legislation, any foreign manufacturer who wants to launch their products in Mexico should have a local office or must appoint a Mexican Registration Holder (MRH) for their licensing requirements.
COFEPRIS (ComisiÃ³n Federal para la ProtecciÃ³n contra Riesgos Sanitarios), the health authority in Mexico, requires a resident of Mexico to be designated as a Registration Holder. This person is also responsible for obtaining and maintaining the product approvals as well as for importing and marketing these products in Mexico. The MRH takes care of all interactions with the COFEPRIS and the health agency then recognizes the MRH as the owner of the license.
Most of the foreign manufacturers normally assign their primary distributor as their MRH. The manufacturer is then completely dependent on their MRH/distributor. COFEPRIS has a provision to add multiple distributors into a single registration. However, should the manufacturer wish to add more distributors or replace the current one, they will require a no objection certificate (NOC) from the MRH. Often, the MRH and the distributor are same entity, which means they can be averse to any changes in the distributor list. This is a potential challenge faced by most of the foreign manufacturers.
As such, some of the key requirements for any manufacturer include easy transfer of license, no single distributor dependency, and a strong Regulatory support for agency interactions throughout the life of the product in the market.
A manufacturer can appoint an independent Regulatory consulting firm like Freyr as their MRH, who can be the license holder without any conflict of interest. The manufacturer can then easily add all the proposed distributors in the product during the registration or any time after registration.
The distributors can handle importing of products independently. This methodology eliminates the dependency on the distributors and gives the manufacturers complete freedom to identify the best possible method for distributing their products in Mexico without any operational hassles.
At any later date, if the foreign manufacturer opens his own office or identifies another MRH to hold the license, there are procedures through which license can be transferred by completing few standard formalities such as authorizing the transfer contract along with the copy of the license and the technical file. Should these standard procedures be hindered, the only workaround will be to submit a new Health Record application with COFEPRIS. Nevertheless, having an independent party as MRH simplifies operations for foreign manufacturers in Mexico.
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This article talks about the effective regulatory strategies for Medical Devices registration across the globe.