Chile’s Health Ministry Strengthens Control of Medical Devices with New Decree

In a significant regulatory update, the Chilean Ministry of Health, on March 6, 2026, published a decree aimed at enhancing the safety and quality standards for medical devices. The decree, published in the Diario Oficial, outlines a comprehensive framework for the regulation of both medical devices and in-vitro diagnostic devices, effectively incorporating them into the country’s health control system.

The decree, which aligns with Chile's broader health and safety regulations, mandates that medical devices, including those used for diagnostics, prevention, and treatment, must now meet rigorous quality control standards. The law stipulates that these products must be certified for safety, performance, and quality, with compliance monitored by the Instituto de Salud Pública de Chile (ISP). This move is in response to international recommendations, particularly from the World Health Organization (WHO), which advocates for proportional control measures based on risk. Medical devices with higher risks, such as those classified as Class III and IV, will face the most stringent scrutiny.

The regulation specifically addresses a range of devices, from diagnostic tools such as pregnancy tests and glucose monitors, to critical therapeutic equipment like pacemakers and defibrillators. These devices will now require certification to ensure that they meet internationally recognized safety and performance standards, such as the NCh ISO norms, and must pass conformity checks before being distributed or sold in Chile.

The decree also introduces an important transitional period for manufacturers and importers. Devices must meet the new regulatory standards within 24 to 36 months, depending on their classification. Notably, for certain high-risk devices, this verification of conformity must be completed in the first two years following the decree's publication. The Ministry has set out a clear schedule for compliance and verification of various devices, including life-saving equipment like defibrillators and surgical implants, which have 24-month deadlines for compliance.

Furthermore, the decree also allows for voluntary conformity assessments before the mandatory deadlines, providing manufacturers with an opportunity to align their products with the new standards early. The ISP will be responsible for ensuring that these devices continue to meet regulatory requirements and will have the authority to suspend any devices found not in compliance. For further information you can find the decree here (in Spanish).