Medical Devices - Chile

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

Medical Devices

In Chile it is required to have the Sanitary Registry of Medical Devices and In Vitro Diagnostic Medical Devices before marketing a product, the sanitary registry of a DM/DMDIV may be requested by the legal manufacturer domiciled in Chile or by an authorized representative or holder , quality that must be accredited.

Medical devices (MD) are defined in Chile as any instrument, device, application, material or item, including software, used alone or in combination and defined by the manufacturer to be used directly on human beings, provided that their main intended action in the human body it is not reached by pharmacological, immunological or metabolic means, although such means may contribute to its function; for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability; research or replacement or modification of anatomy or a physiological process, or regulation of conception.

In order to commercialize, distribute or use the following medical devices in the national territory, the health registration granted by the Institute must be previously obtained, in accordance with the provisions of current regulations:

Aruna Asesores has an expert regulatory team that will accompany it in the planning and execution of the regulatory processes required in Chile for the implementation of these in the market.

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

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