Manufacturers must import their device within the first 3 years of approval, or INVIMA can cancel the registration. Only licensed importers can import medical devices into Colombia. Importers must be identified in the device registration. Medical device registrations with INVIMA are valid for 10 years. Renewals must be initiated at least 3 months prior to the registration expiration. INVIMA has the authority to inspect manufacturers and importers for compliance with medical device regulations. Manufacturers and importers are dually responsible for vigilance activities. Manufacturers and importers are required to submit a summary periodic report on a quarterly basis, even if no adverse events occurred.

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