/ Ministry of Health Issues Regulation on Medical Devices in Chile

On March 19, 2026, the Chilean Ministry of Health published Exempt Decree No. 25, which represents a significant step forward in the regulation of medical devices (MDs) and in vitro diagnostic medical devices (IVDMDs) in the country. This regulation substantially expands the health oversight exercised by the State, aligning it with international standards and adopting a risk-based approach.

Andrea Adasme
Patent Associate
Alessandri Abogados

The decree adds 39 new MDs and IVDDs to the mandatory health control regime provided for in Article 111 of the Health Code. This means that these products must obtain a health registration from the Institute of Public Health (ISP) in order to be manufactured, imported, marketed, or distributed in the country.

Prior to this regulation, health registration was required only for 10 types of MDs/IVMDs—a very limited number of devices—which left many technologies with high clinical impact outside the regulatory system.

The regulation considered the following criteria for incorporating DM/DMDIV into the health control regime: their risk classification, prioritizing Classes III and IV for medical devices and Classes C and D for in vitro diagnostic medical devices; their use in services associated with ministerial plans or programs; and the existence of reports of adverse events submitted to the Technovigilance System.

This will affect both domestic manufacturers and importers, who must primarily and mandatorily obtain a health registration with the ISP and demonstrate compliance with specific national and international standards (e.g., ISO standards).

The implementation will be gradual, starting from the date of publication of this regulation, and will depend on the device’s risk level, as set forth below:

• 24 months: implantable devices and those with higher risk.
• 36 months: all other medical devices.

However, manufacturers or importers may voluntarily initiate the registration process before these deadlines expire, once the ISP issues the corresponding technical guidelines, which must be issued within a maximum of 12 months from the date of publication.

The implementation of this new regulation will be the responsibility of the ISP, through its National Medical Devices Agency.

Finally, some notable examples of medical devices covered by this regulation are as follows:

a) High-Risk Medical Devices (Class III)

• Manual defibrillator monitors
• Mechanical ventilators (stationary and portable)

b) Critical-Risk Medical Devices (Class IV)

• Defibrillators, Pacemakers
• Heart valves

c) In Vitro Diagnostic Medical Devices

• IVD intended for the detection of Helicobacter pylori
• Tests intended for the detection of Human Papillomavirus (HPV)

d) Medical Software (SaMD)

• Software for the processing and analysis of oncological images