Chile — one of Latin America's most developed healthcare markets — currently requires no sanitary registration for most medical devices. That window is real and dated, and there is a voluntary bridge to stay registered once it closes.
October 6, 2026
7
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
In short
Chile currently requires no sanitary registration (registro sanitario) for most medical devices — only contraceptives, gloves, needles, and syringes need ISP registration today. Exempt Decree 25, signed March 6, 2026 and published March 19, 2026, brings 39 device types into mandatory registration: high-risk implantables by March 19, 2028, the rest by March 19, 2029. The decree's transitory article lets importers voluntarily obtain the full registration early — but the technical instructive enabling it is not yet issued, and the certificate-of-free-sale requirement makes it a post-clearance play, not a pre-trial one.
The landscape today: no registration — but not unregulated
Chile's Public Health Institute (Instituto de Salud Pública, ISP) requires sanitary registration for exactly four device types: contraceptives, gloves, needles, and syringes. Every other medical device enters the country through a different door: an ISP-registered importer of record, a per-shipment Customs Destination Certificate (Certificado de Destino Aduanero, CDA) filed on ISP's GICONA 2.0 import platform, and a registered warehouse. Chile's 19% value-added tax (VAT) applies on top.
Read that again: "no registration" does not mean "unregulated." ISP controls every shipment. What it does mean is that there is no product registration dossier standing between your device and the Chilean market today — no multi-month review, no registration number to obtain before your first sale. For an early-stage company, that is a genuine commercial on-ramp.
What changes: Exempt Decree 25
On March 6, 2026, Chile's Minister of Health signed Exempt Decree (Decreto Exento) 25; it was published in the Diario Oficial (Official Gazette) on March 19, 2026, under the authority of Article 111 of the Código Sanitario (Health Code) and Supreme Decree (Decreto Supremo, DS) 825/1998. The decree brings 39 medical-device and in vitro diagnostic (IVD) types into the mandatory sanitary-control regime — meaning they will need an ISP registro sanitario to be manufactured, imported, marketed, or distributed.
The deadlines are staged from the publication date:
- March 19, 2028 — high-risk implantables and critical devices: implantable defibrillators and pacemakers, stents, cardiovascular catheters, heart valves, cochlear implants, hip endoprostheses, breast implants, intrauterine devices.
- March 19, 2029 — the remaining listed types, including other devices, equipment, and IVDs.
If your device is a permanent implant, plan on the 2028 tranche.
The voluntary bridge most people miss
Buried in the decree's transitory articles is a mechanism that changes the strategic calculus. Before the decree takes effect, the decree lets importers, manufacturers, and distributors voluntarily obtain the registration early. The text, verbatim:
"Previo a la entrada en vigencia del presente decreto, los importadores, fabricantes o distribuidores de dispositivos médicos o dispositivos médicos in vitro podrán solicitar voluntariamente ante el Instituto de Salud Pública la verificación de conformidad respectiva, la que para estos efectos consistirá en la obtención del registro sanitario, una vez emitido el instructivo técnico correspondiente."
In plain English: once ISP issues the corresponding technical instructive (instructivo técnico), any importer, manufacturer, or distributor of a listed device may voluntarily request the conformity verification — which, for these purposes, consists of obtaining the registro sanitario itself. Not a provisional certificate. Not a pre-registration. The same registration that becomes mandatory.
A correction: it is not an ANAMED process
You will hear this voluntary path described as an "ANAMED registration." That is wrong, and the distinction matters: the Agencia Nacional de Medicamentos (ANAMED) is Chile's drug agency — it handles medicines, not devices. The device process runs through ISP's medical-device agency, the Departamento Agencia Nacional de Dispositivos Médicos (ANDIM). (You will see ANDID in ISP documents from 2020–2024 — that was the agency's earlier name.) File with the wrong agency in mind and you will waste months.
Three gates that make this a post-clearance play
The voluntary path is real and strategically valuable. It is not, however, a shortcut you can use tomorrow — and it is certainly not a pre-trial move. Three gates govern it:
1. The instructive does not exist yet. The voluntary window opens only after ISP issues the instructivo técnico, which the decree requires within 12 months of publication — by March 19, 2027. As of October 2026, it has not been issued. You cannot file today.
2. The certificate of free sale is a near-absolute blocker for pre-clearance devices. The registration dossier requires a certificate of free sale from the country of origin. The U.S. Food and Drug Administration (FDA) issues its Certificate to Foreign Government only for devices legally marketed in the United States. A device with no FDA clearance and no CE (Conformité Européenne) mark cannot produce one. Practical consequence: registration realistically follows your CE mark or FDA clearance, not your first-in-human study.
3. Filing early has real costs. A voluntary filing locks the registered design, indication, and manufacturing as filed — later changes can force re-registration. Post-market vigilance (tecnovigilancia) obligations attach on grant, not on first sale. And ISP's registration database is public, so filing discloses your product, manufacturer, and Chilean importer to competitors before you control the narrative.
The recommended sequence
Put it together and the strategy writes itself:
- Sell now through an ISP-registered importer of record with per-shipment CDA clearance — no registration dossier required.
- Obtain your reference-market clearance (CE mark or FDA authorization) on the normal timeline.
- Freeze the commercial design — file the version you intend to sell, not the version still evolving in the lab.
- File the voluntary registro once the instructive is out — the identical registration that becomes mandatory.
- Hold registered status before March 19, 2028 (for implantables), with public-tender eligibility and the "registered" institutional signal from day one.
For a device still in first-in-human testing, running the Chilean study on a research import authorization is the cleaner path; the registration comes after clearance, not before.
The regional contrast, in one paragraph
Panama requires a device registro sanitario under its medicines-and-devices framework (Ley 419 of 2024, which replaced Ley 1 of 2001). Colombia, Brazil, Mexico, Argentina, and Peru all require device registration. Chile is the only major Latin American market offering this window — commercial sale without registration today, a voluntary bridge to full registered status, and a dated mandatory horizon.
In August 2026, ISP opened a public consultation on the latest edition of its national technovigilance guidance. Post-market surveillance obligations are firming up ahead of the registration deadlines — factor vigilance planning into your Chile timeline now, not in 2028.
See also our Panama FIH preclinical requirements analysis and the four-country FIH speed comparison.
Frequently asked questions
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