Medical Devices

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*With our services, marketing authorizations are achieved in the countries where we operate, we provide regulatory services, we do not manufacture products

Medical Devices

The group of medical devices includes a number of products with different characteristics. In order to achieve the greatest effectiveness and opportunity in our services, the firm has professionals attached to each of the specialized areas, who are responsible for providing advice on matters related to the sanitary regime, sanitary surveillance and the Sanitary Registry of medical devices in national and imported manufacturing, based on the application of local regulations.

Aruna Asesores has a team of professional experts in local regulations that will advise you on compliance, classification and management in obtaining marketing permits.

Below, you will find the services associated with Medical Devices:

Product classification
Technical and legal management for the presentation of requests for sanitary registration, updating and certification of changes in products classified as Medical Device.
Technical direction support before the health manager of the requests where the owner does not have the service.
Organization of the dossier for the management of obtaining regulatory permits.
Support in obtaining certification processes for importers for CCAA, advice and support for certification in storage capacity of diagnostic reactive devices
Response to processes for ex officio review by health agencies
Legal support in contesting and sanctioning processes before the health agency and defense before health agencies in legal processes, inspections, taking measures.

Product classification
Technical and legal management for the presentation of requests for sanitary registration, updating and certification of changes in products classified as Medical Device
Technical direction support before the health manager of the requests where the owner does not have the service.
Organization of the dossier for the management of obtaining regulatory permits.
Support in obtaining certification processes for importers for CCAA, advice and support for certification in storage capacity of diagnostic reactive devices
Response to processes for ex officio review by health agencies
Legal support in contesting and sanctioning processes before the health agency and defense before health agencies in legal processes, inspections, taking measures.

Check with our professionals online or get frequent questions about registration processes in different countries

Medical Devices

Medical Devices

COLOMBIA AND CENTRAL AMERICA

ARUNA ASESORES SAS

MEXICO

ARUNAMEX SA DE CV

PERU

ARUNA ASESORES PERU

COLOMBIA AND CENTRAL AMERICA

ARUNA ASESORES SAS

MEXICO

ARUNAMEX SC

PERU

ARUNA ASESORES PERU