Chile ISP Decreto Exento N° 25 (2026): what the new mandatory device registration wave changes

Chile is no longer a “light touch if you have CE” story for every medical device. On 19 March 2026 the Ministry of Health published Decreto Exento N° 25, which adds a large set of medical devices and in vitro diagnostic devices to the mandatory sanitary-control regime under artículo 111 of the Código Sanitario. The Instituto de Salud Pública (ISP) — through its medical-device agency function (ANDIM) — is the desk that will issue and police sanitary registration for those products.

If your LATAM launch plan still says “Chile: notify and sell,” rewrite it against the decree, not against last year’s distributor memo.

What the decree actually does

Artículo 111 of the Código Sanitario already said instruments, apparatus, and related articles for diagnosis, prevention, treatment, or anatomical replacement can be placed under sanitary control by founded decree. Older decrees (including Decreto Supremo N° 825 de 1998 and later incorporation decrees such as DS N° 342/2004, DS N° 1.887/2007, DS N° 93/2018, and DS N° 42/2021 for AEDs) already pulled specific product families into ISP registration.

Decreto Exento N° 25 (signed 6 March 2026, published mid-March 2026) expands that list. Public summaries from Chilean counsel and the Ministry’s own communication describe roughly 39 additional device and IVD categories entering mandatory control, with priority on higher-risk classes (Class III/IV devices and Class C/D IVDs), products tied to ministerial care programs, and categories with tecnovigilancia signals. Software as a medical device is in scope where it meets the controlled list — do not assume SaMD is exempt because it ships as a download.

Consequence: manufacture, import, commercialization, or distribution of listed products without ISP sanitary registration is a compliance problem, not a commercial preference.

ISP registration is not a CE photocopy

ChileAtiende’s public fiche for sanitary registration of devices under mandatory control (ISP prestación code 9100003) still points sponsors to the SAFIS system with ClaveÚnica, and to prior steps many importers skip: company inscription, warehouse authorization, and the Certificado de Destinación Aduanera (CDA) path for registered devices. Registration validity is described as three years with automatic extension unless expressly revoked — confirm the current ISP instruction for your class before you put that on a board slide.

ISO certificates and a European CE certificate help the technical story. They do not replace ISP registro for products under artículo 111 control. Build the Chilean file as a Chilean file: Spanish labeling and IFU aligned to the intended purpose you will sell, quality evidence the ISP instruction will demand, and a local party who can answer inspections and tecnovigilancia.

Transition clocks — do not invent a free year

Counsel summaries of Decreto Exento N° 25 describe staggered mandatory deadlines on the order of 24 to 36 months after publication, with ISP technical instructions due within about 12 months so applicants know the exact dossier shape. Treat those as planning bands until you hold the official text and the ISP instructivo for your product codes. Voluntary early filing is the sane move for Class III/IV implants, active devices, and critical diagnostics already on the list — waiting for the last day of a transition window is how launch SKUs miss hospital tenders.

Do not tell sales “we are fine until 2029” without a product-by-product map against the decree annex and a named ISP instruction date.

Holder, warehouse, and tecnovigilancia

Chilean market access fails in operations more often than in the PDF. Lock four roles before you book a launch quarter:

1. Who is the face of the registro. The party ISP will treat as responsible for the Chilean authorization — manufacturer branch or authorized importer/distributor structure that matches how stock actually moves.
2. Who holds the bodega authorization. Registration without a legal storage story is a paper win and a customs loss.
3. Who files tecnovigilancia. Adverse-event and field-safety reporting for controlled devices sits with the sanitary duty of the local controlled party, not with a U.S. complaint desk that “will translate later.”
4. Who owns variations. Model adds, software version bumps, and sterile-barrier changes need a Chilean variation path once registro exists. Quiet EU updates do not auto-propagate.

This is the same titular discipline bioaccess® uses across LATAM registration/IOR work. Chile’s decree wave makes the gap visible because more SKUs just entered the controlled set.

How this interacts with FIH in Chile

A clinical investigation in Chile and a commercial ISP registro are still different workstreams. Do not clear investigational units on a commercial registration number that does not cover the investigational configuration, and do not tell the hospital that “Decreto 25 means we can skip ethics.” Ethics and ISP clinical pathways remain their own calendars. What the decree changes for founders is the commercial LATAM plan: Chile is now a registration-heavy market for a much wider device set.

Where teams burn quarters

Three Chile mistakes after Decreto Exento N° 25:

• Assuming CE Mark equals ISP registro. CE evidence supports the technical file. Artículo 111 control still needs ISP sanitary registration for listed products.
• Leaving SaMD and accessories off the SKU map. Controllers, patient apps, and sterile accessories often decide class and control status. Map the commercial configuration, not only the implantable core.
• Signing a distributor LOI before bodega and titular clarity. Revenue commitments without warehouse authorization and a named ISP face create tender risk, not market access.

Put the decree annex next to your Chilean forecast. If a line item is newly controlled and has no SAFIS owner, cut it from the quarter or fund the registro — do not hope customs will waive artículo 111.

One-page Chile gate this week

• List every SKU you intend to sell in Chile in the next 36 months.
• Mark each against Decreto Exento N° 25 and prior artículo 111 decrees (controlled yes/no).
• For each “yes,” name: ISP instructivo status, SAFIS owner, bodega status, CDA owner, tecnovigilancia owner.
• Separate the FIH/EFS column if you also plan Chilean patients — different dossier, different importer.

If those four owners cannot point to the same intended purpose sentence in Spanish, you are not ready to quote Chilean hospital revenue. For the all-in holder model across LATAM, see bioaccess® market access / LATAM Launch — Chile’s 2026 decree is exactly why “distributor-only” plans break.