Services
For companies interested in marketing their medical devices in the Mexican market, without having to establish a legal entity in Mexico, a Titular Registrant must be appointed as their legal representative in the country.
CAPIBAM® offers independent local representation services as a Titular Registrant Holder before the Mexican Ministry of Health (COFEPRIS) through our office located in Mexico City. The Titular Registrant Holder coordinates the registration application process and maintains control of the official registration (sanitary registration) of the Medical Device with COFEPRIS.
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When you work with us as your Local Representative or Titular Registrant, you're in control; you can appoint and/or change your Distributor at any time.
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This way, you can maintain control and a direct business relationship with your distributors.
REGULATORY COMPLIANCE
Medical devices in Mexico require an official registration (Sanitary Registration), which is granted through the Mexican Ministry of Health.
We support you in the planning, review, integration, and preparation of your file in compliance with current regulatory requirements.
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Official Registration (Sanitary Registration).
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Modifications to the Sanitary Registration conditions
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Administrative Modifications.
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Technical Modifications
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Extensions (Renewals): Class I, Class II and Class III
2. Processing Method:
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Equivalence Agreement
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Traditional
Official Registry (Health Registry) of Medical Devices:
TECHNOVIGILANCE
Discharges of the Manager and the Technovigilance Unit.
Five-YearTechnovigilance Reports .
Technovigilance Unit.
ADVERTISING
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Advertising Notices
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