The regulation expands upon the provisions of Article 111, introducing new measures to strengthen oversight, traceability, and safety within the healthcare system.
On March 19, 2026, the Exempt Decree No. 25 of the Ministry of Health (MINSAL), specifically the Undersecretariat of Health, was published, incorporating a range of medical devices and in vitro diagnostic medical devices into the health control regime.
This establishes new requirements for verifying quality, safety, and performance prior to their manufacture, importation, marketing, or distribution in the country.
The measure is based on the provisions of the Health Code and the Regulations on the Control of Medical Products and Devices, and aligns with international recommendations that promote a regulatory approach based on the health risk posed by the devices. In this context, priority is given to those posing the highest risk, while also considering their use in healthcare services and technovigilance records.
Likewise, the decree establishes the technical standards that will allow for the verification of these devices’ compliance with international standards and specifies that this verification will be carried out by the Institute of Public Health.
39 medical devices and in vitro diagnostic medical devices are covered, which generally include diagnostic equipment, clinical monitoring equipment, treatment equipment, and medical software, as well as critical hospital equipment. Among them are, for example:
- Diagnostic and laboratory devices
- Diagnostic tests or systems for disease detection.
- Medical software for image analysis or therapeutic planning.
- Patient monitoring equipment
- Continuous glucose monitoring systems.
- Automatic sphygmomanometers.
- Therapeutic or life-support devices
- Positive airway pressure equipment (CPAP/BPAP).
- Other equipment used in specialized clinical treatments.
- Hospital and health control equipment
- Steam or ethylene oxide sterilization equipment.
Collectively, these 39 devices primarily correspond to medium- and high-risk medical technologies, many of which are critical for the diagnosis, treatment, and monitoring of patients, and are therefore subject to mandatory health control and registration with the Institute of Public Health
The regulation provides for a gradual implementation, establishing a timeline for entry into force starting from its publication in the Official Gazette.
In particular, the requirement for conformity verification for the devices covered will take effect progressively, with deadlines of 24 and 36 months, depending on the type of device.
This period aims to facilitate the adaptation of manufacturers, importers, and distributors to the new regulatory requirements.
During the transitional phase, interested parties may voluntarily request conformity verification from the Public Health Institute, which must also issue, within a maximum period of 12 months, the technical guidelines establishing the procedure and applicable requirements for such certification.
For more information on these topics, please contact our Public Law and Regulated Markets team:
Antonio Rubilar | Partner | arubilar@az.cl
Dafne Guerra | Director of Life Sciences and Competition Law | dguerra@az.cl
Francisco Alarcón | Senior Associate | falarcon@az.cl
Alejandra Bascur | Associate | abascur@az.cl
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