Why Chile’s ISP Regulates Medical Device Clinical Trials Differently From Drug Trials, and Where It Doesn’t

Sponsors comparing Latin American countries often hear a shortcut about Chile: device studies only need ethics approval and an import permit, and the regulator stays out of the way. That shortcut is out of date. Chile’s Instituto de Salud Pública (ISP) authorizes both drug trials and device trials. The real differences sit somewhere else: in which agency inside ISP handles the file, which rules were written with devices in mind, and how settled the device guidance is.

The short version

• Same legal gate. Since Ley 20.850 (2015), Código Sanitario Article 111 A requires an ISP “autorización especial para uso provisional con fines de investigación” for pharmaceutical products and medical devices (“elementos de uso médico”) used in research on humans.
• Ethics first. The ISP application comes after approval under Article 10 of Ley 20.120, which requires a favorable report from an accredited Comité Ético Científico (CEC).
• Different agencies. Drugs go through ISP’s Agencia Nacional de Medicamentos (ANAMED). Devices go through the Agencia Nacional de Dispositivos Médicos (ANDIM).
• Different rulebooks. Several older Chilean research instruments, including Norma Técnica 57, were written for medicines. The device route rests mainly on the Código Sanitario and device-specific ISP guidance, and some of that guidance is still being finalized.

Two agencies inside one institute

ISP is Chile’s national regulator for medicines and medical devices. Drug work, including ISP’s clinical studies pages for investigational medicines, sits under ANAMED. Device work sits in ANDIM. On its agency page, ISP describes ANDIM as responsible for the safety and performance of medical devices, including in vitro diagnostic devices (IVDs), through authorization, control, inspection and surveillance across the whole device life cycle.

A standalone device goes to ANDIM. A combination product may involve both.

What is the same for drug and device trials

The CEC review comes first

Ley 20.120 is Chile’s law on scientific research in human beings. Its regulation, Decreto Supremo (DS) 114 of 2010, as amended in 2013, requires every study to have “una revisión e informe favorable de un Comité Ético Científico acreditado.” For multicenter studies, one accredited committee does the scientific and ethical review, and each site adds a local feasibility evaluation. Under DS 114 Article 18, the CEC must issue its report within 45 days of submission, a deadline it can extend once by 20 days for stated reasons.

Article 111 A then makes the order explicit: the ISP application is filed “previa aprobación conforme a lo dispuesto en el artículo 10 de la ley N°20.120,” with the protocol, the informed consent form, the insurance policy and any other document the regulation requires. For devices and drugs alike, the CEC letter comes before the ISP file.

ISP issues a provisional-use authorization

Article 111 A says the authorization is required for any drug or medical device used in research that lacks a sanitary registration, or that has one but will be used differently from how it was registered. The authorization lasts up to one year and can be renewed. The product can only be used as the authorization allows, and ISP must keep a public registry of the research it authorizes.

Shared obligations during and after the study

• Safety reporting: adverse events go to ISP and the CEC, under pharmacovigilance rules for drugs and technovigilance rules for devices (Article 111 B).
• Post-trial access: the authorization holder must continue treatment at no cost while it remains useful, as described in the protocol (Article 111 C). Our note on post-trial access in Chile under Ley 20.850 covers how this works in practice.
• Site accreditation and inspection: research centers must be accredited by ISP, which can inspect protocols, consent, GCP compliance and safety reporting (Article 111 D).
• Liability and insurance: authorization holders are liable for harm caused by the research (Article 111 E) and must carry civil liability insurance under the applicable regulation (Article 111 F). For devices, Article 111 F says a supreme decree sets the device classes for which insurance is mandatory. Our note on Chile clinical trial insurance covers the ethics-committee side.
• Institutional sign-off: under DS 114 Article 10 bis, the director of each research site authorizes the study within 20 business days of the favorable CEC review and, where applicable, the ISP authorization.

Where drug and device trials genuinely differ

The older rulebook was written for medicines

Much of what sponsors read about Chilean trial rules comes from instruments that name drugs, not devices:

• Código Sanitario Article 99 lets ISP provisionally authorize the use of pharmaceutical products without registration for clinical trials, subject to a favorable CEC report.
• DS 114 Article 7 gives ISP the power to “autorizar el uso de medicamentos con o sin registro sanitario, con fines de investigación científica y ensayos clínicos.” The article speaks of medicines only.
• Norma Técnica 57, approved by Ministry of Health (MINSAL) Exempt Resolution 952 of 2001, is titled “Regulación de la ejecución de ensayos clínicos que utilizan productos farmacéuticos en seres humanos.”

For devices, the legal basis is Código Sanitario Article 111 A. It is backed by Article 111 letter g, which says ISP must authorize the use and disposal of the medical elements covered by Article 111, and by DS 825 of 1998, the regulation on the control of medical-use products and elements. A drug-trial checklist will not map cleanly onto a device file.

What ISP looks at

For drugs, ISP has said publicly that it assesses the investigational medicine “teniendo a la vista el protocolo del ensayo clínico, el manual del investigador y certificaciones” such as Good Clinical Practice (GCP) and Good Manufacturing Practice, and decides by reasoned resolution (ISP, 2020).

For devices, ISP ran a public consultation from 5 June to 5 July 2026 on a guide explaining how to organize an application for provisional-use authorization of a medical device in clinical research in humans. Check whether the final guide has been published before you assemble your file. Until it is, build the dossier around ISO 14155:2020, the international standard for good clinical practice in medical device investigations: the clinical investigation plan, the investigator’s brochure, and the risk analysis behind them. Then confirm the exact document list with ANDIM.

A possible exemption for low-risk devices

Article 111 A lets MINSAL exempt, by supreme decree, “los elementos de uso médico cuya utilización no conlleve un riesgo relevante para las personas.” Article 111 A offers no equivalent carve-out for drugs. We have not confirmed that an exemption decree is in force, so treat this as something to check for your device, not an assumption.

Commercial registration status plays a different role

Most medical devices in Chile still do not need an ISP sanitary registration to be sold. ISP’s own registration page lists ten device and IVD types under mandatory registration. Exempt Decree 25 of 2026 adds 39 more. Registration becomes mandatory for 13 of them 24 months after publication (19 March 2028) and for the other 26 after 36 months (19 March 2029). The decree governs manufacture, import, sale and distribution, and it does not mention clinical investigation. An investigational device therefore does not need a registro sanitario. It needs the Article 111 A authorization. Our Chile ISP clinical-trial path for medical devices explains how to keep the trial file and the Decree 25 registration file on separate timelines.

What this means for your timeline

Because the CEC review comes before the ISP application, a Chilean device study runs in sequence: ethics review, then ISP authorization and investigational import, then the site director’s authorization. The primary sources set some of the clocks: 45 days for the CEC report (extendable once by 20 days) and 20 business days for the site director. For the ISP step, our Chile ISP device trial page plans on about 30 business days after a complete package, to be confirmed at filing. For overall first-in-human (FIH) activation, our Latin America FIH startup-clock guide puts Chile in the 15–45 day fast-corridor band. Treat both as planning figures, not guarantees.

So the fair comparison with the US is not “no regulator review in Chile.” It is an ISP device authorization that follows an accredited CEC review, with legal deadlines on the ethics and site-director steps.

Chile, IMDRF and using the data elsewhere

ISP says Chile has been an affiliate member of the International Medical Device Regulators Forum (IMDRF) since November 2023. Affiliate status signals regulatory convergence. It does not mean ISP accepts another regulator’s decision in place of its own trial authorization.

If you plan to use Chilean data outside Chile, design the study for that from day one. Under 21 CFR 812.28, the US Food and Drug Administration (FDA) can accept a foreign clinical investigation that supports an investigational device exemption (IDE) or a marketing submission, if the study was well designed, well conducted and followed GCP, including independent ethics committee review and informed consent, and FDA is able to validate the data, by inspection or other means if needed. In Europe, the EU Medical Device Regulation (MDR) 2017/745 sets out clinical investigation requirements in Article 62 and Annex XV. Your notified body will judge how data generated outside the EU fits your clinical evaluation.

Checklist for device sponsors considering Chile

• Confirm the file goes to ANDIM, and flag early any drug or biologic component.
• Choose a lead accredited CEC and each site’s local review route before you finalize the protocol.
• Prepare the Article 111 A package: protocol, Spanish informed consent form, insurance policy, and ISO 14155-aligned device documents.
• Check whether ISP has published the final device provisional-use guide, and whether any low-risk exemption or insurance-class decree applies to your device.
• Plan investigational import alongside the ISP step, not after it.
• Keep any Decree 25 commercial registration work on a separate timeline.

Frequently asked questions

Does Chile’s ISP approve medical device clinical trials, or only the import?

ISP does more than clear the import. Código Sanitario Article 111 A, added by Ley 20.850 in 2015, says drugs and medical devices used in research on humans need a special provisional-use authorization from ISP. That applies when the device has no sanitary registration, or when it has one but will be used differently from how it was registered.

Does the ethics committee or ISP go first in Chile?

The ethics committee goes first. Under Article 111 A, the sponsor files with ISP only after the study has been approved under Article 10 of Ley 20.120, which requires a favorable report from an accredited Comité Ético Científico (CEC). The application must include the protocol, the informed consent form and the insurance policy.

Does Norma Técnica 57 apply to medical device trials?

Not on its face. Norma Técnica 57, approved by Ministry of Health Exempt Resolution 952 of 2001, regulates clinical trials that use pharmaceutical products in humans. The device rules come from Código Sanitario Articles 111 and 111 A, Decreto Supremo 825 of 1998 and ISP guidance. Confirm current requirements with ISP.

Does an investigational device need a registro sanitario before a trial in Chile?

No. Commercial sanitary registration and research use are separate. Article 111 A covers devices that do not have a registration, which is why the trial needs ISP’s provisional-use authorization instead. Exempt Decree 25 of 2026 widens commercial registration but says nothing about clinical investigations.

Can data from a Chile device study support an FDA or EU submission?

It can, if the study is designed for that. Under 21 CFR 812.28, FDA can accept a well-designed, well-conducted foreign study that followed good clinical practice, including independent ethics review and informed consent, if FDA can validate the data. For Europe, plan against EU MDR Article 62 and Annex XV. Acceptance is decided case by case.

This article is general information, not legal advice. Requirements change, and ISP’s device research guide was under public consultation in 2026. Verify current requirements with ISP and your CEC before filing.

Considering Chile for a device study? bioaccess® can map feasibility, CEC routes, ISP authorization and site access for your protocol. Contact bioaccess® at bioaccessla.com to start.