Your Strategic Gateway to the Mexican Market

At Santrion, we streamline your COFEPRIS medical device registration. End-to-end regulatory management, from pre-submission strategy through post-registration compliance.

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COFEPRIS Medical Device Registration: Our 6-Phase Process

01.

Strategic Consulting

We determine the risk classification, audit quality compliance (GMP/ISO), and map out fast-track pathways through Equivalency Agreements (FDA, Health Canada, Japan).

02.

Dossier Compilation

Full localization of the technical dossier. This includes specialized medical and legal translations, followed by the formal submission through the COFEPRIS platform.

03.

Regulatory Defense

Active monitoring of the submission to protect your investment. We offer legal acceleration and manage constitutional injunctions (amparos) in the event of regulatory delays.

04.

Approval & Regulatory Hosting

We act as your independent Registration Holder and maintain an active Technovigilance (post-market surveillance) system while you select your local distributor.

05.

Commercialization

We manage the initial import permits and execute the official transfer of rights to your final commercial partner.

06.

Regulatory Maintenance

Long-term support: technical modifications, 5-year renewals, and advertising compliance for your devices.

Strategic Entry to the Mexican Market

We manage the registration of Class I, II, and III medical devices with absolute technical rigor. Ensure regulatory compliance for your technology from day one.

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Start Your Registration Process

Provide your technology's specifications, and our experts will conduct a complimentary regulatory feasibility assessment.