Specialized Regulatory Strategy for Medical Devices in Mexico.
Access to and operation within the Mexican healthcare environment require highly precise technical management that integrates regulatory compliance with operational viability.
At Capibam, we address the complexities of COFEPRIS regulations with a comprehensive consulting approach. We optimize every stage of the regulatory process to eliminate administrative fragmentation, ensuring results aligned with our clients' standards of excellence and overall objectives.
HOLDER - HOLDING
(Local Representation in Mexico)
We act as the holder of your sanitary registrations in Mexico, providing the necessary legal and sanitary infrastructure for your operation. Our Holder solution allows global companies to maintain strategic control and ownership of their assets in the Mexican market without the need to establish their own legal entity, guaranteeing complete legal and regulatory protection.
CAPIBAM® offers independent local representation services as a Registration Holder with the Mexican Ministry of Health (COFEPRIS) through our office located in Mexico City. The Registration Holder coordinates the registration application process and maintains control of the official registration (sanitary registration) of the Medical Device with COFEPRIS.
Regulatory Compliance
Official Registration (Sanitary Registration) of Medical Devices:
We handle the planning, technical review, and consolidation of documentation for obtaining Official Registration (Sanitary Registration) from the Ministry of Health (COFEPRIS). Our practice is based on rigorous regulatory compliance, which includes determining the most strategic processing route—whether through an Equivalence Agreement with international agencies (FDA, Health Canada, MHLW) or through the Traditional Process—for medical devices in all categories.
We manage the administration of current authorizations with institutional precision, including modifications to the Sanitary Registration conditions, in both their administrative and technical aspects. We also proactively coordinate the renewal process for Class I, Class II, and Class III technologies, ensuring that each submission complies with current regulatory requirements. This approach eliminates operational fragmentation and guarantees the legal certainty necessary for the commercial continuity of our clients in the Mexican market.
Compliance with Technovigilance
We execute the necessary technical processes to ensure compliance with Tecnovigilance obligations before COFEPRIS (Federal Commission for Protection against Sanitary Risks). Our services include the establishment and formalization of the Tecnovigilance Unit, as well as the registration of the responsible party with the health authority. We also manage the preparation and submission of the Five-Year Tecnovigilance Reports, ensuring that each technical requirement is met with the rigorous standards demanded to maintain the integrity of your records in Mexico.
Regulatory Control of Advertising
We manage the legal compliance of your marketing communications by submitting the Advertising Notices to the health authorities. We ensure that the promotion of your medical devices strictly adheres to current regulations, providing the necessary regulatory certainty for a solid and professional institutional presence in the Mexican market.
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