ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country highlighted on the cover of Market Pathways' print issue. The September 2025 cover features the National Congress building in Valparaíso, Chile.
Regulation
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Key Leader: María Cecilia López Gutiérrez, Head of Medical Devices Registration Office, ISP |
Key Authority: Public Health Institute of Chile (ISP) POINTS OF INTEREST
- Only 0.7% (94 of 12,800) of high-risk devices are currently under active regulatory control, according to ISP.
- ISP was recently award $2.5 billion by Chile’s economic development agency to expand the scope of its device regulation infrastructure.
- In January, legislation was introduced in the National Congress to strengthen ISP’s regulatory authority over devices and IVDs.
Market Access
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Leader: Ximena Aguilera Sanhueza, MD, Health Minister |
Key Authority: Ministry of Health POINTS OF INTEREST
- Chile imports more than 90% of medical devices on its market.
- Healthcare in Chile is funded by a combination of a public health fund (FONASA) and a tax-funded private insurance system (ISAPRES).
- Device procurement can either go through the CENABAST centralized healthcare supply agency or smaller, private procurement processes at hospitals and clinics.
More Resources
- Chile’s recently published quality management system guidance document and more details on the $2.5 billion investment to strengthen device regulations are discussed in Market Pathways’ latest Docs of the Month column as one example of tangible harmonization efforts that are being advanced in multiple regions.
- María Gutiérrez, ISP device office chief, presented a regulatory update during the March 2025 meeting of the International Medical Device Regulators Forum (IMDRF) in Tokyo.
- The Chile chapter of the International Bar Association’s 2025 “Healthcare and Life Sciences Law Committee Survey on Healthcare Financing and Reimbursement” offers a thorough account of how healthcare, included medical devices, are funded in the country.
