Source: This article adapts and expands themes from Julio G. Martinez-Clark’s guest column on Med Device Online (published September 11, 2026): “Chile’s Easy Market Ends In 2028.” Read the full column there; what follows is an original bioaccess® operator brief for manufacturers building a Latin America (LATAM) market-access plan — not a reprint.
For years, Chile was the LATAM medtech market where a strong distributor and an importer of record (IOR) could often move faster than a full sanitary-registration campaign. Only a short mandatory list — contraceptives, gloves, needles, and syringes — required Instituto de Salud Pública (ISP) registration for most commercial paths. In 2021 I asked on Med Device Online how long that “easiest market” window would last. Exempt Decree No. 25 answers it: the easy years run through 2026; the compressed years are 2027–2028.
What changed: Exempt Decree No. 25
On March 19, 2026, Chile published Exempt Decree No. 25 in the Diario Oficial (Núm. 44.404, CVE 2781436). The decree pulls 39 numbered medical device and in vitro diagnostic (IVD) types into the sanitary-control regime under Article 111 of the Health Code and Decree Supreme No. 825. ISP describes the set as higher-risk, widely used products tied to ministerial programs, with conformity verification based on quality, safety, and performance documentation.
The legal machinery was already there — Decree Supreme No. 825 long required conformity-verification certificates for covered devices. Earlier exempt decrees had used that structure for narrow categories (for example sterile hypodermic needles and syringes). The difference now is scale: 39 types, including software as a medical device and multiple IVDs, phased into mandatory ISP sanitary registration.
Two waves — and why the calendar is not the real clock
First wave (24 months / 13 types in Artículo primero transitorio): deadline March 19, 2028. Includes cardiovascular implants and catheters, heart valves, cochlear implants, orthopedic and soft-tissue implants, copper intrauterine devices (IUDs), insulin infusion pumps and accessories, blood bags, and related numbered types in the decree.
Second wave (36 months): deadline March 19, 2029. Includes imaging, radiotherapy, dialysis, ventilation, extracorporeal circulation, electrosurgical, ophthalmic, continuous glucose monitoring (CGM), continuous positive airway pressure / bilevel positive airway pressure (CPAP/BPAP), sterilization, oncology software, and several IVD categories.
Seeing 2028 and assuming “plenty of time” is the first operational mistake. Decree No. 25 gives ISP up to 12 months from publication to issue the technical instruction for conformity verification. Voluntary filing is allowed only after that instruction exists. If the how-to lands near the 12-month mark, manufacturers in the first wave may have roughly one usable year — not two — to interpret requirements, assign ownership, assemble and translate files, close standards gaps, coordinate Chilean partners, submit, answer questions, and obtain registration. That is a compressed portfolio campaign, not a leisurely runway.
Registration readiness now beats distributor-first strategy
Chile’s older entry model made distributor selection the first strategic move. After the applicable transition dates, covered products may only be manufactured in Chile, imported, marketed, or distributed with the required conformity verification — which the decree frames as ISP sanitary registration. That shifts commercial leverage: if the distributor imports but nobody owns the Chile file, modification path, and continuity if the channel changes, you have built regulatory risk into the sales model.
Treat this as a LATAM market-access problem, not a one-country paperwork chore. Many manufacturers still use Chile as an early regional entry point because of institutional stability and provider quality. When Chile stops being “import and sell,” the regional launch sequence changes. Map registration and portfolio triage before you lock distribution strategy. (For how bioaccess® packages market-access work, see the market-access rate card — without inventing case-specific rates here.)
Do not confuse pathways. A clinical-trial authorization or investigational import route is a different file from commercial sanitary registration. It is not 2028 commercial cover. For Chile clinical-operations context, see our Chile clinical trials country page; keep investigational and commercial tracks separate in governance.
Standards, Spanish dossiers, and postmarket (tecnovigilancia)
Decree No. 25 points manufacturers toward an explicit standards-based review — including general references such as NCh ISO 16142 (parts 1 and 2), NCh ISO 13485, and NCh ISO 14971, plus product-specific standards for the 39 categories. Chile-ready work is a technical-file readiness exercise, not a local stamp.
ISP guidance on essential principles of safety and performance already expects devices and IVDs to meet intended performance with risks acceptable relative to benefit, and to ship identification, safety, and use information in castellano (Spanish). Existing FDA, EU MDR, MDSAP, or ISO 13485 packs help — they are not automatically a Chile dossier. Family/group/system filings may not match Chile’s grouping expectations; labels and instructions for use (IFU) may need Spanish updates; legacy lines may have documentation gaps.
Waiting for ISP’s technical instruction before doing any work wastes the only runway that matters. As of late August 2026 that instruction had not been issued. Final forms can wait; portfolio mapping, standards-gap assessment, Spanish labeling review, and local-role design cannot.
Postmarket is part of the transition. ISP’s announcement on Decree No. 25 frames the reform as support for postmarket surveillance. Chile already operates tecnovigilancia (technovigilance) enrollment and adverse-event reporting expectations — including precise device identification (lot, model, series, manufacturer, intended use), not generic labels like “catheter” or “valve.” Traceability under related Chilean technical norms belongs in the same operating model as registration. Approval without a Chile-specific complaint, reporting, field-action, and file-sync plan is incomplete market access.
Five triage moves manufacturers should make now
- Map the decree to the live Chile catalog — every model, accessory, software module, kit, and family currently sold, against scope and transition group.
- Rank by two-year commercial necessity — some legacy SKUs will not justify registration; platform anchors and consumables drivers often will.
- Assess technical-file readiness before the instruction drops — risk management, QMS certificates, Spanish labeling, accessory documentation.
- Define local responsibility — who files, maintains, modifies, answers ISP, and owns postmarket vigilance; “the distributor” is an answer only if it protects long-term flexibility.
- Budget a multiyear wave — governance, timelines, document owners, escalation — not a one-off filing event.
What 2021 got right — and what the instruction gap changes
Directionally, the 2021 Med Device Online column was right: Chile was not going to stay unusually open forever. The vehicle that landed is Decree No. 25 via the Ministry of Health and ISP (with ANDIM in the implementation picture), not the legislative script many watched at the time. Scope is larger than the old four-category mandatory list — 39 numbered types. The underweighted piece in 2021 was the instruction gap: a two-year transition looks generous until the agency has up to a year to write the how-to and early filing is gated on that how-to.
Chile remains a serious, commercially attractive market with its own regulatory culture. What ended is the assumption that listed device types can enter without a sanitary-registration strategy. Map the catalog now.
References
- Julio G. Martinez-Clark, “Chile’s Easy Market Ends In 2028,” Med Device Online, September 11, 2026 — https://www.meddeviceonline.com/doc/chile-s-easy-market-ends-in-0001
- Julio G. Martinez-Clark, “Medtech In Chile: Currently Latin America’s Easiest Market, But For How Long?” Med Device Online — https://www.meddeviceonline.com/doc/medtech-in-chile-currently-latin-america-s-easiest-market-but-for-how-long-0001
- Ministerio de Salud de Chile, Decreto Exento N° 25, Diario Oficial March 19, 2026, Núm. 44.404, CVE 2781436 — https://www.bcn.cl/leychile/navegar?idNorma=1222514
- Ministerio de Salud de Chile, Decreto Supremo N° 825 — https://www.bcn.cl/leychile/navegar?idNorma=141005
- Instituto de Salud Pública de Chile, announcement on the new norm regulating 39 medical devices including IVDs — ISP notice
Disclaimer: This post is general information for educational and commercial-planning purposes. It is not legal advice and is not a substitute for advice from qualified Chilean counsel or confirmation with ISP on current filing instructions, product classification, or transition applicability to a specific portfolio.
bioaccess® helps manufacturers sequence LATAM market access — registration ownership, IOR design, and distributor strategy — so Chile’s 2028/2029 waves do not become a last-minute scramble. Contact bioaccess® · Book a meeting