Medical devices (“dispositivos medicos” in Spanish) are any instrument, apparatus, application, material or article, including software, used by themselves or in tandem, and defined by the manufacturer to be used directly on human beings, when the main expected action on the human body is not achieved by pharmacological, immunological or metabolic means, although those means can contribute to its function; with the propose of diagnosis, prevention, follow up, treatment or relief of a sickness, damage or disability; of research or replacement or modification of anatomy or of a physiological process or the regulation of conception. (Decree N˚ 825/98, article 2, n˚1).
According to the Sanitary Code and Decree 825/98, the regulation of medical devices will be done progressively, via specific Supreme Decrees signed by the Ministry of Health. This specific Decrees specify the devices’ Class and so the regulatory controls and requisites that apply to them.
Devices are divided into four different classes, that have different regulatory requirements. The class is determined by the Supreme Decree that submits the devices to regulation. The classes are the following:
Devices that have very low risk
Devices that have moderate risk
Devices that have an elevated risk potential
Devices considered critical risk
Only two kinds of devices are under mandatory regulation:
According to article 3 of Decree 825/98, persons or companies that pretend, at any title, to fabricate, import, commercialize or distribute medical devices need to obtain certification of the verification of conformity on the services, institutions, laboratories or establishments that contain a specific sanitary authorization, emitted by the “Instituto de Salud Publica”, Public Health Institute, of Chile.
There are no specific requirements regarding manufacturers (except, following the definition, that they need to define the device as to be used directly on human beings) or Initial Importer (except to obtain the needed authorization, if the device is under mandatory regulation). However, the import process must follow the usual regulations for bringing items to the country.
Specific regulatory conditions for selling devices do not exist on the general regulations but can be imposed by the specific Supreme Decree that regulates the medical device. Of course, as for imports, to sell medical devices subject to mandatory regulation, a verification of conformity must be obtained from an accredited institution.
There are no specific restrictions for advertisements regarding medical devices, though they could be imposed by Supreme Decrees regulating specific medical devices. However, there are restrictions on advertisements of pharmaceutical products, defined by the sanitary code and specific Decrees.
The Chilean government started a program to monitor all medical devices in all hospitals to report malfunctions and every institution will have a person in charge of this duty. This might bring new regulations to these products.