Authorization and notification
Resolution E5435/2026 approves guidance that describes separate provisional-use authorization and notification pathways. Which pathway applies depends on factors such as device risk class and study design.
For medical device sponsors in Chile
Clinical studies.
Compliance in practice.
As Chile’s Public Health Institute (ISP) clarifies how device studies should be prepared and run, Velarassi helps Chilean sponsors understand what applies and build it into day-to-day study operations.
Regulatory update · 12 November 2026
What changed in Chile
The ISP approved two guides in 2026. One addresses provisional use of devices in clinical investigations. The other sets out good clinical practice for those investigations.
A clearer submission package
The provisional-use guide describes how to assemble the study dossier. It covers documents such as the clinical investigation plan, investigator’s brochure, device conformity documentation and the favorable opinion of a scientific ethics committee.
More detail on study conduct
The ISP’s device good clinical practice guide provides direction on sponsor oversight, risk management, monitoring, safety reporting and study records. The provisional-use guide also addresses changes to authorized studies and extensions.
Confirm the pathway for your study
Article 111 A of the Health Code already provides the legal basis for provisional use. The new guides add procedural and technical detail. In vitro diagnostic devices are outside the scope of the provisional-use guide. Confirm current implementation, available filing procedures and applicable ethics steps with the ISP or qualified Chilean advisers before setting a submission date.
Velarassi clinical operations
Build compliance into your study.
We work with Chilean sponsor teams and their local advisers to put applicable requirements into practice, from the first planning meeting through study closeout.
Map the requirements
Identify gaps, assign responsibilities and map the timing of ethics review, ISP steps and site activation around the pathway confirmed for your study.
Prepare the study file
Coordinate the investigation plan, informed consent, device documentation and supporting materials. Track versions and responses to review questions.
Keep oversight on track
Set up monitoring, safety reporting, change control and recordkeeping so your team can document how it meets applicable requirements throughout the study.
Contact
Let’s talk about your study.
For an initial conversation, share the study stage, regions under consideration and the operational support you’re looking for.
hello@velarassi.com