How to register a medical device in Chile with ISP (Decreto Exento 25 and CDA)

Sponsors still write “Chile registration” as if ISP ran a single on/off switch. It does not. Some device categories already need sanitary registration. Many others still enter through a Certificado de Destinación Aduanera (CDA). Decreto Exento No. 25 of 2026 is expanding the mandatory list on a staged calendar — and Boletín 17.375-11, the broader risk-based reform bill, is not law yet.

I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial Chile file: how a medical device gets onto the Chilean market under the Instituto de Salud Pública (ISP), when CDA is still enough, and how Decreto Exento No. 25 changes the planning calendar. It sits next to our LATAM market-access hub, the Chile ISP country page, and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

One-sentence answer

Commercial sale in Chile requires ISP sanitary registration when your device category is under the sanitary-control regime of Article 111 of the Código Sanitario and Decreto Supremo No. 825 of 1998 — including the 39 categories Decreto Exento No. 25 of 6 March 2026 (Diario Oficial 19 March 2026) is pulling in on 24- and 36-month transition dates — while devices still outside a mandatory category typically import under a CDA until their category’s clock starts.

Two Chile desks — do not merge them

Investigational use. Ethics and clinical-research authorization for first-in-human or other device studies. That file is not a license to sell. Chile’s ethics timing and ISP research facts live on our Chile FIH / ethics pages, not on this commercial brief.

Commercial path. Manufacture, import, commercialization, or distribution of a device that already has a clearance story elsewhere (often FDA or CE). For categories already under sanitary control — and for categories Decreto Exento No. 25 will make mandatory after their transition dates — the conformity verification for that purpose is an ISP registro sanitario. For devices not yet in a mandatory category, ISP and Aduanas still use the CDA pathway for customs destination of unregistered devices.

If your Gantt has one bar labeled “ISP,” check whether the product is on a mandatory list today, on Decreto Exento No. 25’s 2028/2029 waves, or still CDA-only. Those are three different work packages.

What Decreto Exento No. 25 actually does

Published in the Official Gazette on 19 March 2026 (CVE 2781436), Decreto Exento No. 25 incorporates listed medical devices and IVDs into the sanitary-control regime under Article 111 of the Código Sanitario and DS No. 825/1998. Once each category’s transitional date arrives, those products may only be manufactured in Chile, imported, marketed, or distributed if they hold the corresponding ISP sanitary registration.

Planning anchors from the decree and the public transition tables operators are using in 2026:

• Technical instructives / complementary resolutions — target window within about 12 months of publication (around March 2027)
• Higher-risk / implantable wave — about 24 months (around 19 March 2028) for the first listed group
• Equipment, IVDs, SaMD, and remaining listed categories — about 36 months (around 19 March 2029)
• Voluntary early filing — the decree allows voluntary ISP registro before a category’s mandatory date once the instructivo técnico exists

Do not treat those dates as “we can ignore Chile until 2028.” Distributor selection, Spanish labeling, and holder appointment take longer than a board slide admits — and voluntary early registro is often the cleaner commercial story for US/EU manufacturers already shipping into Chile under CDA.

Boletín 17.375-11 is not the current rule

The broader bill that would move Chile toward open-ended, risk-based device authorization and put recognition of foreign approvals on a clearer statutory footing is Boletín 17.375-11. It is still a bill. Plan against Decreto Exento No. 25, DS No. 825/1998, and current ISP practice. Do not promise a board that Chile already runs a full IMDRF-style reliance regime for every class.

What belongs in the commercial dossier (operator list)

Exact ISP forms and instructivos move with ANDIM practice. The working stack sponsors assemble before translators start is stable:

• Device identity, intended use, and whether the product sits in a mandatory category today or on a Decreto Exento No. 25 wave
• Manufacturer and manufacturing sites, with quality-system evidence appropriate to the claimed category
• Technical evidence already used for FDA or CE, mapped to ISP’s petition — not dumped as a zip of US folders
• Labels and IFU in Spanish for the configuration you will sell
• Local legal entity / holder documentation — Chile’s commercial face of the file
• A written CDA-versus-registro decision for every SKU you intend to import before its mandatory date

Electrical/EMC or RF homologation for wireless devices, when required, runs through Chile’s telecom authority (SUBTEL) as a separate vendor track. Do not bury that inside the ISP sanitary clock.

What this file is not

• It is not a clinical-trial authorization. Trial units and commercial units follow different petitions.
• It is not a CDA forever. A CDA for an unregistered device is not a substitute for ISP registro once the category is mandatory.
• It is not Boletín 17.375-11. Do not sell “future recognition of FDA” as today’s pathway.

How bioaccess® runs the Chile holder seat

On the live market-access offer, bioaccess® holds and manages Chilean registrations through our own local entity for sanitary registration, importer-of-record duties, sworn translations, government fees, and holder-side post-market work. Pricing for the LATAM Launch Subscription is published on bioaccessla.com/market-access (USD 7,500 per year per country for the first device family; additional families at the published add-on rates). Timelines on the Chile page are typically 30–90 days experience-based planning ranges once the dossier is ready — confirmed at proposal against the current ISP queue. We do not invent a statutory day-count here.

Operator checklist before you open a Chile registro folder

1. Map every SKU to mandatory-today, Decreto Exento No. 25 wave (2028/2029), or CDA-only.
2. Write “trial” and “commercial” on two pages if you still need human data in Chile.
3. Decide the local holder before you pick a distributor.
4. Confirm the sellable configuration matches Spanish labels and IFU — not an investigational configuration.
5. Budget SUBTEL / RF tracks separately when the device is wireless.
6. If you are already selling under CDA into a category on the 2028/2029 waves, decide whether voluntary early registro is cheaper than a scramble later.

Talk with bioaccess® when you need Chile registro held independent of the commercial channel — or when you are sequencing a Chile FIH into a later ISP market file without mixing the desks.