Mexico Market Access for Medical Devices and IVDs

View our Mexican Market Access services

We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

Certificate of Free Sale (CFS) for Medical Device Exports

Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries around the world.

Classification of Medical Devices in Mexico

Emergo can assist you with classification of medical devices in Mexico to meet COFEPRIS regulatory requirements.

COFEPRIS medical device and IVD registration and approval in Mexico

Emergo by UL can help you with COFEPRIS medical device registration and approval to sell your product on the Mexican market.

ISO 13485:2016 Consulting and Gap Analysis

ISO 13485:2016 is coming! Let Emergo help you transition from ISO 13485:2003 or ISO 13485:2012. Local offices throughout the US, Canada, Europe and Asia.

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ISO 14971 Risk Management Consulting for Medical Device Companies

ANSWERED ON THIS PAGE:

What does ISO 14971 require?
How do I implement ISO 14971?
How do I apply the risk management system and concepts to my product?

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Local Authorized Representative for Medical Device Manufacturers

Emergo by UL can act as an independent, local authorized regulatory representative for medical device and IVD manufacturers seeking global market access.

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Mexico Registration Holder for Imported Medical Devices

Emergo by UL offers COFEPRIS Registration Holder Representation services for medical device companies seeking to sell their product in Mexico.

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Vigilance Reporting for Medical Devices in Mexico

Implement medical device vigilance reporting system and report adverse events, recalls and post-market monitoring as required by Mexican COFEPRIS requirements.

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