Chile Category-by-Category Control Model and List Risk

1. Key takeaways

Not every medical device requires mandatory registration in Chile. Only the categories explicitly included by category-by-category inclusion decrees must obtain sanitary registration (registro sanitario) before being manufactured, imported, sold or distributed. The legal root of this model is letter d) of Article 111 of the Sanitary Code: the application of the control regime to a specific category must be implemented by the Ministerio de Salud, on ISP proposal, through a reasoned decree adopted category by category.

GRZAN adds a time limit to this conclusion: the shelf life of the sentence “my product is not on the list” is shrinking fast. The Decreto Exento N° 25, de 2026, published on March 19, 2026, moved the controlled categories from about 10 to 39 in a single action, and the selection criteria published with it signal clearly which products will be swept in next.

The enforcement machinery behind the model is already in place and needs no new legislation. Letter f) of Article 111 and Article 30 of DS 825/1998 attach seizure to sale or distribution without registration, and the SEREMI of each region carries the inspection and sanctioning mandate. In other words, the list is not advisory; every line of it is backed by an enforcement power that operates on goods found in the market. The only sound reading of the Chilean model is therefore prospective: assume the list will reach your product category eventually, and manage the timing of inclusion rather than betting on its absence.

2. Legal basis

• Sanitary Code | DFL N° 725, de 1967 | current Article 111 | letter d): through reasoned decrees issued by the Ministerio de Salud, on ISP proposal, the provisions of this Article are made applicable to each category of device; the decree must list the technical specifications on which control is based.
• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 22: the category of each specific device is designated by the inclusion decree.
• Same source | Article 3: controlled devices require a prior conformity verification certificate.
• Decree including listed devices in the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | March 19, 2026 | includes 39 categories of medical devices and in vitro diagnostic medical devices in one action.
• Article 111 of the Sanitary Code | letter f) and DS 825/1998 | Article 30: sale or distribution without the required registration results in seizure.

3. Expert insights

Insight 1: this is a structure of delegated legislation plus phased implementation, not a regulatory vacuum.

Chile has a complete four-class risk classification and tiered dossier requirements (Articles 20 and 21 of DS 825/1998); what was missing was the activation decree deciding which products the regime applies to. A complete system applied in phases is fundamentally different from having no system at all. When assessing product risk, no assumption may rest on the premise that Chile does not regulate; the correct premise is that Chile regulates by list, and the list is growing.

Insight 2: the list is dominated by high-risk items, showing the expansion logic is risk-first rather than a blanket rollout.

The selection criteria of the Decreto Exento N° 25, de 2026 include: the criticality of the device, its risk class (prioritizing Class III and IV devices and Class C and D IVDs), whether it is used in ministerial programs or related services, whether it has been included in quality evaluation programs, and whether adverse event reports exist in the technical vigilance system. This means the next batch of expansion is highly predictable: products with adverse event records, or products that have entered public procurement catalogs, are candidates for early inclusion. Monitoring those signals gives manufacturers genuine forecasting power.

Insight 3: the two reverse risks of not being on the list must be managed simultaneously.

The first is seizure risk: letter f) of Article 111 and Article 30 of DS 825/1998 directly provide for seizure of goods sold or distributed without a certificate. The second is timing risk: a product currently outside the list that fails to complete registration before the transition period of the Decreto Exento N° 25, de 2026 expires will face channel interruption. GRZAN recommends converting list comparison from a one-time judgment into a quarterly mechanism, so that both risks are re-priced on a fixed rhythm.

A third, quieter risk deserves mention: assumption risk. Sales teams tend to carry forward conclusions from earlier market assessments — that Chile requires nothing beyond a distributor letter — and those conclusions age silently. Since the selection criteria published with the 2026 decree are public, every quarterly review can also refresh the forecast: if a product now matches the criteria of criticality, risk class, ministerial programs or adverse event history, its probability of inclusion has risen and the dossier timetable should be pulled forward accordingly. Treating the forecast as a number rather than a feeling is what separates mechanism from habit.

4. Practical recommendations

1. Build a product-to-list comparison table: compare line by line against the annex of the Decreto Exento N° 25, de 2026 by intended use plus technical characteristics, never against a distributor’s email or past experience.
2. Use the selection criteria for forward-looking prediction: if the product is Class III/IV, enters public procurement, or has adverse event records, plan production on the assumption that the next expansion will very likely include it.
3. Prepare a technical file skeleton even for off-list products: ISO 13485, the risk management report, and Spanish-language labels and instructions for use form the universal base; preparing them in advance can compress the post-expansion submission cycle by several months.
4. Include a list-change clause in distribution agreements: stipulate that once the product is included, each party must initiate the registration submission within a defined number of days, avoiding channel gaps.

5. Verification checklist

• □ Compared the product line by line against the annex of the Decreto Exento N° 25, de 2026 by intended use and technical characteristics
• □ Recorded the risk class of the product (I–IV or A–D)
• □ Assessed whether the product hits any of the four selection criteria (criticality, risk class, ministerial programs, adverse events)
• □ Established a quarterly list review mechanism
• □ Included a list-change initiation clause in the distribution agreement

Regulatory information verified as of October 29, 2026.

For a Chile market-entry feasibility assessment covering your specific product, contact the GRZAN regulatory team. GRZAN provides ISP registration and compliance support for the Chilean market: annex-level list comparison, expansion forecasting based on published selection criteria, off-list readiness planning, and distributor agreement reviews. Reach us at info@grzanglobal.com.