How do you register a medical device with the ISP in Chile?

Decreto Exento 25 de 2026 brought 39 device types into mandatory sanitary control in Chile — here are the dossier documents, timelines, titular rules, and tecnovigilancia obligations for market entry.

October 1, 2026

13

min read

By

BioAccess Editorial Team

Chile

ISP

medical device registration

market access

Latin America

registro sanitario Chile

Decreto Exento 25

**Key takeaways**

• • Chile works by declaration of control. Registration is mandatory only for device categories the Ministry of Health has declared under control sanitario — historically gloves, condoms, needles/syringes, portable AEDs, and HIV IVDs, now joined by 39 device and IVD types under Decreto Exento 25 de 2026.
• • Compliance deadlines: March 2028 and March 2029. High-risk implantable and critical devices have 24 months from the decree's publication (19 March 2026); the rest of the included devices have 36 months.
• • No direct foreign registration. The registro must be held by a company established in Chile acting under a written mandate from the manufacturer — the ISP's GICONA system requires a Chilean RUT.
• • Official review target: 60 business days for a complete filing; the registro is valid for 3 years, automatically extended for equal periods.
• • No formal fast track for FDA-cleared or CE-marked devices — but foreign conformity evidence (CFS, FDA letters, CE certificates, ISO 13485) speeds evaluation.

**Who is this for?**

This guide is for regulatory affairs directors, market access managers, and MedTech executives planning to commercialize medical devices in Chile — whether your portfolio falls under the 39 types newly incorporated by Decreto Exento 25 de 2026 or you are mapping what the regime means for future launches.

The short answer

Whether your device needs ISP registration depends on which category it falls in — and the answer changed on 19 March 2026. Historically, Chile required a registro sanitario only for specific device categories the Ministry of Health declared under control: surgical and exam gloves, condoms, sterile single-use hypodermic needles and syringes, portable automated external defibrillators, and HIV in-vitro diagnostic tests. On 19 March 2026 the Diario Oficial published Decreto Exento N° 25 de 2026, which brings 39 medical-device and in-vitro diagnostic types — including stents, cardiovascular catheters, implantable defibrillators and pacemakers, mechanical ventilators, CT scanners, insulin infusion pumps, glucose-monitoring systems, and selected high-risk IVDs — into the mandatory sanitary-control regime of article 111 of the Código Sanitario. The obligation is phased: high-risk implantable and critical devices must be registered within 24 months of publication (March 2028); the rest of the included devices get 36 months (March 2029). The registro must be held by a company established in Chile — a foreign manufacturer cannot hold it directly. For manufacturers who want a turnkey path, see bioaccess®'s market access services.

What is the ISP and what law requires registration?

The Instituto de Salud Pública de Chile (ISP) is the autonomous public-health institute under the Ministry of Health (MINSAL). Device oversight sits with its national device agency — created as the Agencia Nacional de Dispositivos Médicos, Innovación y Desarrollo (ANDID) and operating in practice as the Departamento Agencia Nacional de Dispositivos Médicos (ANDIM), the unit tasked with implementing Decreto Exento 25 de 2026. The legal framework rests on:

• Código Sanitario, artículo 111 — subjects the manufacture, importation, internación, commercialization, distribution, and use of medical devices to sanitary control by the ISP
• D.S. N° 825/1998 (Reglamento de control de productos y elementos de uso médico) — sets the risk classes (I–IV), conformity-verification rules, and registry mechanics
• Individual 'control' decrees declaring specific categories subject to registration: D.S. N° 342/2004 (gloves, condoms), D.S. N° 1887/2007 (needles and syringes), Decreto Exento N° 93/2018 (synthetic condoms), D.S. N° 42/2021 (portable AEDs), Decreto Exento N° 41/2022 (HIV IVDs)
• Decreto Exento N° 25 de 2026 — incorporates 39 device and IVD types into the control-sanitario regime, the largest single expansion of Chile's device regime

Until Decreto 25, Chile was the opposite of a blanket-registration market: everything was importable under the ISP's Certificado de Destinación Aduanera (CDA) unless its category had been expressly declared under control. That model is now closing in stages — which is exactly why mapping your device against the new decree is the first step of any Chile plan.

Decreto Exento 25 de 2026: what changed?

Promulgated on 6 March 2026 and published in the Diario Oficial on 19 March 2026 (short reference: bcn.cl/XsHz0K), the decree follows a 2025 public consultation with industry associations. It incorporates into the article 111 regime devices the ISP describes as "higher risk and widely used in health benefits associated with ministerial programs." The included categories:

Three practical consequences follow from the decree's text:

• Compliance is phased from publication: 24 months for high-risk implantable and critical devices (March 2028) and 36 months for the rest of the included devices (March 2029).
• The ISP itself acts as the organismo de verificación de conformidad for the incorporated devices — the conformity verification and the registration run through the same institute.
• The decree allows a voluntary early conformity-verification process once the ISP issues the corresponding technical instructive, which must happen within 12 months of publication (by March 2027) — filing early is the obvious strategy for devices in the 24-month tranche.

**Relevant modifications require a new registration**

Any relevant change in design, manufacturing, or intended use of a registered device requires a new registro sanitario — not a simple variation. Freeze your design configuration before filing, or budget for re-registration.

Which devices need ISP registration — and which do not?

Chile's regime is still not universal registration — it is declaration of control, category by category. The table below summarizes where things stand as of October 2026:

If your device sits in a gray zone — a common situation for combination products, accessories, and SaMD — the ISP offers an official ruling on the device's regulatory status: the Declaración de Situación Regulatoria de Dispositivos Médicos (procedure 9200005), which states whether a device is under control sanitario under the current regulation. File it early; it is the document that settles internal debates about whether you need a registration at all.

**Do not assume 'no registro' means 'no ISP involvement'**

Even devices without mandatory registration are imported through the ISP's CDA process — per lot or shipment, with an authorized warehouse as the destination. Unregistered-by-design is fine; unregistered-by-omission is not a strategy.

How are devices classified in Chile?

Chile classifies devices into four risk classes — I, II, III, and IV — under article 20 of D.S. 825/1998, following the GHTF/IMDRF risk model detailed in the ISP's 2018 classification guide. IVDs use the parallel A–D classes. Classification depends on intended use, invasiveness, duration of body contact, whether the device contacts the central circulatory or nervous system, and energy or medicinal-substance delivery — not simply on implantability:

Note the Chilean nuance visible in the Decreto 25 lists: cardiovascular catheters and stents sit in Class IV — the highest class — which places them in the 24-month high-risk tranche. Most non-implantable interventional devices (peripheral diagnostic catheters, guidewires, sheaths) fall in Classes II or III, in the 36-month tranche. For Classes III and IV the ISP additionally expects a risk-management plan and report (ANDID instructive 001, section 6.6).

Can a foreign manufacturer register directly with the ISP?

No. The registro sanitario is issued in the name of a titular — a natural or legal person established in Chile, acting under a written mandate from the foreign legal manufacturer. The ISP's own instructive (ANDID/024) defines the "representante autorizado o titular" as any person or company established in Chile that has received and accepted a written mandate from a manufacturer located outside the country, and under whose ownership the device's registro sanitario sits. The filing runs through the ISP's GICONA system, which requires a Chilean RUT, prior company inscription, and an authorized warehouse — a manufacturer without Chilean presence cannot open the procedure.

The manufacturer recognizes its Chilean partner through a document in which it acknowledges the applicant as its authorized representative or distributor — one of the required dossier items (see below). The same Chilean company that holds the registro typically acts as the importer of record, since every shipment of a device under control needs a CDA and an Autorización de Uso y Disposición issued to it.

**Titular choice is a commercial decision, not just a regulatory one**

Changing the titular later is a formal procedure requiring a new mandate from the manufacturer — a frequent commercial friction point when the distributor holds the registration. Our recommendation for Chile: appoint your Chilean distributor as the titular (holder) and importer of record, engage a third-party regulatory provider like bioaccess® to prepare and prosecute the ISP filing, and build registration-transfer clauses into your distribution agreement — reviewed by Chilean counsel to ensure they are locally enforceable — so the registro can be transferred to a replacement distributor if the first one fails to meet expectations. (Argentina is the exception: it is a large enough market that bioaccess® provides full titleholder and importation services there directly.)

What must the Chilean company set up before filing?

Before the product filing can be opened in GICONA, the Chilean company must complete three establishment prerequisites — plus designate its tecnovigilancia contact:

The practical sequence is: Chilean entity with RUT → authorized warehouse → ISP company inscription → product registration (if under control) → CDA per shipment → Autorización de Uso y Disposición → commercialization. Foreign manufacturers commonly ask their Chilean distributor to hold all five steps, which is exactly why the distributor-titular model — with bioaccess® prosecuting the product filing — is the standard arrangement.

What documents does the ISP dossier require?

The official procedure (prestación 9100003, version 03 of 25/09/2025) lists the following documents "according to the type of device" — i.e., the full list below, with the ISP applying what corresponds to each product:

Note how compact the Chilean dossier is compared with a full ANVISA or COFEPRIS technical file: the conformity-verification certificate does the heavy lifting, and foreign-origin evidence (FDA clearance letters, CE certificates, notified-body reports, ISO 13485) is accepted as conformity evidence — so a manufacturer with FDA 510(k) or CE marking is already holding much of what the ISP will want to see.

**Apostille rule of thumb**

Every public or notarized foreign document — CFS, manufacturer letters, notarized ISO/CE/FDA copies — must be consularized or apostilled. Chile is a Hague Apostille Convention party, so apostille (rather than consular legalization) applies for most origin countries. Label and IFU projects must be in Spanish.

How long does ISP registration take?

The ISP's published standard for procedure 9100003 is 60 días hábiles (business days) on average, provided no additional background is required. If the reviewer finds gaps, the ISP issues an ordinario de completitud (deficiency letter) with a 5-business-day response deadline under Ley N° 19.880 — a tight turnaround, so the dossier must be complete before filing.

For the devices newly incorporated by Decreto 25, the ISP still has to publish the technical instructive (expected by March 2027) and scale its review capacity — so the 60-business-day standard is best read as the statutory target, not a guarantee for first-wave filings in 2027–2028. bioaccess® confirms the expected timeline at the proposal stage based on the device's class and dossier readiness.

What does ISP registration cost?

ISP government fees are set by the current ISP tariff (the procedure page shows "Ver precio" — check the price on the current arancel). They are modest relative to comparable Latin American regulators, but the tariff changes by resolution, so confirm the current schedule at the proposal stage. The real budget drivers are the same as elsewhere in the region: dossier preparation, apostille and Spanish translations, conformity-verification evidence, samples, and the in-country filing work. Government fees are a small line item; the commercial cost is the in-country regulatory work.

The registro sanitario is valid for 3 years from the date of notification, and "this period is understood to be automatically and successively extended for equal periods, while it is not expressly revoked" (Código Sanitario, article 7; ISP procedure 9100003 v3). bioaccess® provides ISP registration processing as a quoted service — dossier preparation, translations, agency liaison, and tecnovigilancia — while your Chilean distributor holds the registro. See bioaccess®'s market access services for current commercial terms.

Is there a fast track for FDA-cleared or CE-marked devices?

There is no formal fast track for FDA-cleared or CE-marked devices. Chile does operate a reliance mechanism — but only for pharmaceuticals: the ISP's Resolución Exenta N° E679/25 created an internal reliance procedure for biological products, referencing agencies of high health vigilance (FDA, EMA, MHRA, TGA, PMDA). No equivalent regulation exists for devices under D.S. 825/1998.

That said, Chile's conformity-verification model is document-based and explicitly open to foreign-origin evidence — recent decrees (e.g., Decreto Exento 41/2022 for HIV IVDs) provide that verification is carried out through document review, which may incorporate background of foreign origin. In practice:

• A Certificate of Free Sale plus ISO 13485 and the origin-market authorization (FDA clearance/approval, CE certificate, or another recognized regulator) form the core of the file
• FDA 510(k)/PMA letters and notified-body reports are accepted as conformity evidence within the verification
• The review is not a de-novo technical re-evaluation of design verification — foreign evidence genuinely shortens the process

Practical implication: manufacturers with FDA 510(k) clearance or CE marking already hold the most valuable documents in the file. The remaining work is Chilean: the titular, the apostilled manufacturer letter, Spanish labeling and IFU, and the conformity-verification filing itself.

What are the tecnovigilancia obligations?

Chile runs a national tecnovigilancia (post-market device vigilance) system coordinated by the ISP under the Norma General Técnica N° 204 on patient safety and device-use safety. It applies to all medical devices and IVDs available on the domestic market — not just those under mandatory registration. Key obligations for the titular, manufacturer, importer, and distributor:

• Formally appoint a tecnovigilancia officer and an alternate, and maintain internal procedures to collect, retain, and analyze complaints, events, incidents, and field safety corrective actions (FSCAs)
• Notify the ISP of adverse events and incidents using the official forms (ANDID/006 for devices; ANDID/010 for IVDs) to tecnovigilancia@ispch.cl
• Manage field safety corrective actions and recalls in coordination with the ISP
• Report market withdrawals and adverse events for devices under control sanitario (D.S. 825/1998, article 28)

In August 2026 the ISP launched a public consultation on new national tecnovigilance system guidance, intended to replace previous editions and strengthen the prevention, detection, investigation, and reporting of adverse events and incidents, plus FSCA and recall management — another sign that the device-control buildout extends well beyond registration. Contractually, the manufacturer–distributor agreement should assign who reports to the ISP, the internal deadlines for the Chilean titular to receive information from the manufacturer (and vice versa), and how recalls are executed in Chile.

What happens if you import without registration?

Two tracks of consequence. At the border: every import of a device under control sanitario requires a Certificado de Destinación Aduanera (CDA) — required by Ley N° 18.164, article 2, naming the authorized warehouse as destination — and an Autorización de Uso y Disposición (UyD) from the ISP before the goods can be commercialized. Without them, the shipment is not released. Administratively: operating without the registro triggers a sumario sanitario (Código Sanitario, articles 161–173) with:

• Fines from 1/10 to 1,000 UTM — doubled on repeat offenses (article 174)
• Establishment closure, authorization cancellation, and activity stoppage (articles 174–175)
• Confiscation or destruction of the products, prohibition of commercialization, and market withdrawal (article 178)
• Separate customs liability under the Ordenanza de Aduanas for imports without the CDA

Enforcement is real and visible: in May 2026 the ISP, through ANDIM, issued a safety alert ordering the immediate withdrawal of unregistered Wondfo rapid HIV tests — a Class D IVD sold online without a valid registro — citing violation of article 111 and the applicable decrees, and prohibiting their importation, commercialization, and distribution nationwide. The 39 devices incorporated by Decreto 25 are precisely the categories the ISP selected based on tecnovigilancia adverse-event reports, so expect the agency to watch them.

Frequently Asked Questions

Sources and basis of this article

This article is based on the Chilean regulatory framework as of October 2026: Código Sanitario, artículo 111; D.S. N° 825/1998 (Reglamento de control de productos y elementos de uso médico); Decreto Exento N° 25 de 2026 (Diario Oficial 19-MAR-2026, bcn.cl/XsHz0K); the ISP's procedure 9100003, v3 (25/09/2025, ispch.gob.cl) and procedure 9200005 (ispch.cl); the ISP's 20 March 2026 notice on the decree (ispch.cl); Norma General Técnica N° 204 (tecnovigilancia); Ley N° 18.164, artículo 2 (CDA); and regulatory analysis with Mike Legal AI (decision support, not a licensed attorney). Fees, timelines, and decree-level details change by ISP notice — confirm the current tariff and requirements with the local titular or the ISP directly before budgeting. This article is general information, not legal advice.

BA

bioaccess® · An Americas company operating from Canada to Argentina — end-to-end medical device registration and market access services, including ISP (Chile), DIGEMAPS (Dominican Republic), COFEPRIS (Mexico), ANVISA (Brazil), INVIMA (Colombia), and ANMAT (Argentina).

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Ready to register your device with the ISP?

Chile is the Southern Cone's most sophisticated device market — and its regulatory framework is in the middle of its biggest expansion in a generation. Whether your device falls under one of the 39 types incorporated by Decreto Exento 25 or you are planning for the next categories the ISP will add, the path runs through a Chilean-domiciled titular, an authorized warehouse, and an apostilled dossier. bioaccess® prepares and prosecutes your ISP filing as your third-party regulatory provider — dossier, translations, agency liaison, and tecnovigilancia — while your Chilean distributor holds the registro as titular and importer of record, with transfer clauses in your distribution agreement protecting you if the commercial relationship changes.

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Related resources:

• Market Access Services — /market-access
• First-in-human medical device trial in Chile — /blog/first-in-human-medical-device-trial-chile
• Latin America medtech market-entry strategy 2026 — /blog/latin-america-medtech-market-entry-strategy-2026-a-bioaccess-guide