Medical Device Registration in Mexico
Regulatory authority: The Federal Commission for Protection of Sanitary Risks (COFEPRIS) is responsible for registering any healthcare product. The regulatory system consists of mandatory standards known as NOMs and voluntary standards known as NMXs.
Classification: Medical device classification is based on the EU system. Additionally, grouping of harmonized tariff codes, family criteria, and low risk devices and accessories is required.
To market a product in Mexico, the manufacturer must have approval in their country of origin and an MRH (Mexican Registration Holder) in Mexico. The local representative is responsible for the registration and must submit all required product information to the MOH. For standard submissions, a technical file similar to an EU technical file must be submitted for premarket review. An expedited review process may allow devices that have been approved by the USA FDA or Health Canada to be reviewed within 3-4 months instead of the standard review time which can take years. FDA and Health Canada certification can allow for an expedited registration process with proper documentation.
Timeframe of registration: Medical devices registered in Mexico can take several years to get approved. Using the expedited method, review times are 3-4 months.
Length of license: Licenses issued in Mexico expire every five years.
As of 2012, Arazy Group now offers our new service, Licensale.com. This unique, cloud-based application provides you, the medical or IVD device manufacturer, with a comprehensive service that results in the successful registration of your product in Mexico and ownership of the registration license through your company.
Once you register in Mexico through Licensale.com, a global compliance profile is generated that easily facilitates the registration of your product in more than 80 countries around the world. Licensale.com creates a foundation that makes registration simpler, faster, and more cost-effective than any alternative available today.
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