Chile Medical Device Regulations / Dental Device


Hello everyone ,

is the following correct:

"Only four types of medical devices are subject to mandatory registration with Chile's National Drug Agency (ANAMED in Spanish), a dependency of the Institute of Public Health (ISP in Spanish): contraceptives, gloves, needles, and syringes. Other medical equipment and devices do not need regulatory registration."

This means that no registration is required for other products and the import and sale is not regulated.

Thank you very much.

Dragon Ki

Hello, registered specialist in Chile
Since only four types of medical devices require compulsory registration, other products are registered by voluntary means. Where can I check the requirements of the regulations on voluntary registration. It will make my product more popular when it is sold in Chile.
Thank you very much!
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