Sponsors mix two Chile clocks into one bar labeled “ISP.” One clock is Instituto de Salud Pública (ISP) authorization for a medical-device clinical investigation and investigational import. The other is commercial sanitary registration under Chile’s expanding Exempt Decree No. 25 wave. They are not the same petition. Confusing them is how a Santiago FIH plan quietly becomes a 2028 market-access scramble.
I am Julio Martinez-Clark, CEO of bioaccess®. This page is the operator brief for running a medical-device clinical trial in Chile under ISP — and keeping that trial file off the commercial registro track. It is grounded in the live FIH startup clock, fast-track FIH corridor, Chile Exempt Decree No. 25 / ISP registration 2028, and Chile site posts such as Hospital Luis Tisné Santiago. It is not a quote and not legal advice. Confirm current ISP, ethics, and import instructions before you file.
Two Chile files — write them apart first
- Investigation file (this page). ISP authorizes the clinical investigation and investigational-device import. An Ethical-Scientific Committee under Law 20.120 still has to sit. Success criterion: authorized research use of the named investigational article at named sites.
- Commercial registro file (different Gantt). Exempt Decree No. 25 (published 19 March 2026) expands mandatory ISP sanitary registration across 39 product types, including software as a medical device and multiple IVDs, with transition waves toward 2028/2029. Success criterion: conformity verification / ISP sanitary registration for manufacture, import, marketing, or distribution of covered products after the applicable transition dates.
Live Chile blogs already put a typical ISP investigation review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file. Do not put both on one Gantt labeled “Chile.”
Where Chile sits on the FIH map
Chile is inside Latin America’s fast-track FIH corridor with Panama, El Salvador, and Costa Rica. Published corridor activation band: 15–45 days. Panama remains the documented extreme (~15-day activation; ethics-submission ID in about 3 business days). Chile’s published role in that corridor is different: corridor speed plus top-tier perceived data rigor — the combination sponsors look for when they do not want a “small fast market” discount on the evidence package.
Speed drivers on the live corridor page: efficient ethics and ISP pathways; experienced committees. Cost tier: upper among corridor countries — you pay for depth and perception. Population is still small; feasibility and backup sites matter.
What ISP owns on the trial track
- Clinical-investigation authorization. ISP is the investigation desk for device studies in Chile. A named hospital campus on ClinicalTrials.gov is not the ISP applicant and is not the operator of the ISP file.
- Investigational-device import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See the regional investigational import guide.
- Not commercial registro. Post-Decree 25 market access (technical instruction from ISP within up to 12 months of publication, Spanish IFU/label expectations, tecnovigilancia enrollment) belongs on the commercial track. Keep it off the FIH critical path until first patient is locked.
We will not invent PAHO/WHO Level 4 standing for ISP. All bioaccess® device protocols in this country run under ISO 14155 and the Declaration of Helsinki.
Ethics under Law 20.120
An Ethical-Scientific Committee under Law 20.120 still has to sit. Institutional ethics calendars at Chilean hospitals are real — and they are not ISP. Share committee calendars and hospital research rules with the CRO early. Do not wait for the ISP letter to discover that the committee meets monthly and your Spanish informed-consent text is still in draft.
Operator rule: same protocol version and same Spanish informed-consent text across the ethics packet and the ISP packet. The commercial IFU you will later lock under Decree 25 is not the ethics ICF.
Submission checklist (investigation dossier)
Assemble the universal FIH core once, then layer Chile. Do not invent form codes that are not on live bioaccessla.com pages — use this operator checklist against ISP’s current published requirements at filing time.
| Section | What to freeze | Operator check |
|---|---|---|
| Protocol | Version, endpoints, stopping rules | Same version for ISP and Ethical-Scientific Committee |
| Investigator’s brochure / preclinical | Risk profile for first human use | Matches the article on the investigational device list |
| Informed consent (Spanish) | Ethics-ready castellano | Not the commercial IFU for Decree 25 registro |
| Insurance | Trial-related injury coverage | Territory names Chile; language matches ethics packet |
| ISO 14155 monitoring plan | GCP bridge for foreign data | Design for 21 CFR § 812.28 inspectability if a U.S. file is intended |
| Investigational labeling | For clinical investigation only | Lot/serial traceability matches site accountability |
| Device / accessory list | Every unit in the accountability log | Quantities match what import will request |
| Importer of record | Legal name before ethics stamps | Document ties shipment to investigation authorization — not a commercial ISP certificate |
| Ethics letter (Law 20.120) | Ethical-Scientific Committee outcome | Keep correspondence in one trial master file |
| ISP investigation authorization | Study authorization + import path | ~30 business-day planning band; confirm at filing |
Import: investigational units are not the Decree 25 SKU
Name the trial importer before ethics stamps the protocol. Map every investigational model, accessory, and spare to the investigation-authorized list. Outer labels must read as investigational. After last patient, close investigational inventory under the trial rules. Leaving units “for the hospital” without a new sanitary path is a new regulatory event, not a courtesy.
Hand-carry is not the plan. Formal, traceable importation tied to the trial authorization is required across Latin America; Chile is not an exception.
If the Chile FIH must support a U.S. file
Design the investigation so the evidence room can satisfy 21 CFR § 812.28 (acceptance of data from clinical investigations conducted outside the United States): GCP, independent ethics review, and a device comparable to the version you will put in front of FDA. ISO 14155 is the device GCP bridge. A clean ISP investigation letter does not replace an inspectable trial master file. Eligibility of foreign data under § 812.28 is not a clearance prediction. See the live 812.28 LATAM inspectability page.
Do not smear the hospital — and do not skip ISP
Named Santiago campuses on ClinicalTrials.gov (for example Hospital Luis Tisné, Clínica Colonial) are real hospital strings. They can discuss investigator interest, local visit costs, and ethics calendars. They cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR § 812.28 packager. The First-in-Human CRO still owns those workstreams — plus the option to add another Latin American country if one Chilean campus is not the only enrollment fit.
Common rejection / delay patterns
- One “ISP” bar for trial and registro. Investigation (~30 business days planning) versus commercial registration (30–90 days planning; Decree 25 waves later) are different files.
- Commercial certificate on investigational freight. Decree 25 / sanitary registration paperwork does not clear FIH kits.
- Hospital NCT string treated as the regulatory plan. Campus ≠ ISP file.
- Importer named after first patient. Import then becomes the critical path.
- Waiting for ISP’s Decree 25 technical instruction before any commercial readiness. That is a market-access problem — keep it off the FIH critical path, but do not ignore it for launch planning.
One-page gate before first patient in Chile
- Authority map: ISP investigation + Ethical-Scientific Committee (Law 20.120) versus commercial ISP registro under Exempt Decree No. 25 only if launch is truly in scope.
- Same protocol version and same Spanish informed-consent text across ethics and ISP packages.
- Investigational importer named, with the document that ties the shipment to the investigation authorization.
- Device list complete, including accessories.
- ISO 14155 file owner who can produce monitoring, accountability, and ethics letters within 48 hours if FDA asks.
- Feasibility: real site-level patient flow for your indication — corridor speed does not create patients.
Related reading on bioaccessla.com
- Chile’s easy market ends in 2028: Exempt Decree No. 25 and ISP registration
- FIH Latin America startup clock
- Panama, El Salvador, Chile, Costa Rica: fast-track FIH corridor
- Importing investigational devices into Latin America
- Hospital Luis Tisné Santiago: NCT campus ≠ ISP file
- FDA 21 CFR 812.28 in LATAM
- Independent sanitary registration holder strategy
- Medical device registration & market access
Planning a Chile FIH file — ISP investigation, Law 20.120 ethics, and investigational import kept off the Decree 25 registro track? Talk with bioaccess® — contact Julio Martinez-Clark at jmclark@bioaccessla.com or +1 (954) 903-7210.