Decreto Exento 25/2026: Chile Expands to 39 Categories

1. Key takeaways

Decreto Exento N° 25, de 2026 (published in the Official Gazette on March 19, 2026) is the largest expansion of device regulation in Chile in nearly three decades: it includes 39 categories of medical devices and in vitro diagnostic medical devices in a single action, dominated by Class III and IV devices and Class C and D IVDs; it sets two transition periods of 24 months and 36 months; it requires the ISP to publish technical guidance within 12 months of publication; and it provides that significant changes affecting quality, safety or performance require a new registration application.

The core GRZAN judgment: waiting until 2029 is the most expensive strategy. ISP review capacity is limited, and for the newly included categories there are currently no accredited private conformity verification bodies, so the ISP must perform verification itself — a queue is inevitable in 2027 and 2028. Submitting after the guidance is published but well before the mandatory deadline is the only cost trough in this round of expansion.

2. Legal basis

• Decree including listed medical devices and in vitro diagnostic medical devices in the sanitary control regime of Article 111 of the Sanitary Code | Decreto Exento N° 25, de 2026 | published March 19, 2026 in the Official Gazette | body text: includes 39 categories pursuant to Article 111 of the Sanitary Code and DS 825/1998; transition provision: implantable and higher-risk products at 24 months, all other products at 36 months; transitional clause: the ISP must publish technical guidance within 12 months of publication, after which companies may voluntarily apply for conformity verification in advance; change clause: significant changes require a new registration application.
• Sanitary Code | DFL N° 725, de 1967 | Article 111 letter d) | implementation category by category through reasoned decrees (the legal basis of this decree).
• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 20 (classification), Article 21 (dossier requirements), Article 22 (classes designated by the inclusion decree).
• Standards cited by the decree | NCh-ISO 16142-1, NCh-ISO 16142-2, NCh-ISO 13485, NCh-ISO 14971 | the standards on which conformity evaluation is based.

3. Expert insights

Insight 1: scope — the 39 categories cover five major blocks.

Insight 2: the two transition periods are divided by product risk, not by company size.

24 months applies to implantable and higher-risk products (to approximately March 2028), and 36 months applies to all other products (to approximately March 2029). Different product lines of the same manufacturer can therefore fall under two different deadlines, and production planning must be annotated SKU by SKU rather than agreed at company level.

Insight 3: the 12-month guidance window determines the starting point of the early-mover advantage.

The ISP must publish technical guidance within 12 months of publication (before approximately March 2027), setting out the submission procedure and dossier requirements; once the guidance is published, companies may voluntarily apply for conformity verification ahead of the deadlines. This time gap is the early-mover window: prepare the dossier before publication and submit immediately afterwards.

Insight 4: significant changes require a new registration application, elevating change management to the strategic level.

The decree provides that where a device undergoes significant changes in design, manufacture or intended use that affect its quality, safety or performance, the certificate holder must apply for a new sanitary registration. Combined with the tiered dossier requirements of Article 21 of DS 825/1998, the pace of product iteration is directly linked to registration maintenance cost, so roadmap decisions should be priced against re-registration exposure.

Insight 5: conformity verification is document-review based; foreign evidence is usable but there is no fast track.

Verification is implemented by the ISP, evaluating the quality, safety and performance evidence of the devices through document review, benchmarked against NCh-ISO 16142-1/2, NCh-ISO 13485, NCh-ISO 14971 and the product-specific standards listed in the annex. This does not constitute mutual recognition of CE or FDA approvals, but evidence of foreign origin may be accepted within that framework.

4. Practical recommendations

1. Run the 39-category list comparison immediately: compare line by line against the annex by intended use and technical characteristics, and output a three-column conclusion table of on-list/off-list, class and transition-period band.
2. Annotate the two deadlines by SKU: implantable and higher-risk products planned against 24 months, everything else against 36 months; never schedule uniformly at company level.
3. Set March 2027 as the dossier readiness node: submissions become possible once the guidance is published, and companies with dossiers ready in advance take the first review slots.
4. Maintain a change impact assessment table: for the five change types of design, materials, sterilization method, intended use and manufacturing site, judge one by one whether a new registration application is triggered.
5. Organize the evidence against the standards list: use NCh-ISO 16142-1/2 as the general framework, NCh-ISO 13485 and NCh-ISO 14971 as the quality system and risk evidence, then layer the product-specific standards on top.

5. Verification checklist

• □ Obtained the original text of the Decreto Exento N° 25, de 2026 and checked the publication date (March 19, 2026)
• □ Completed the line-by-line comparison of the 39-category list and produced the three-column table
• □ Annotated the 24/36 months transition-period bands by SKU
• □ Set March 2027 as the expected publication node for ISP technical guidance and reserved the early-mover schedule
• □ Established the change impact assessment table covering design, materials, sterilization, intended use and manufacturing site
• □ Organized the evidence package against NCh-ISO 16142-1/2, 13485 and 14971

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: 39-category list comparison, transition-period scheduling by SKU, dossier preparation against NCh-ISO standards, and change impact assessment under the new registration regime. Reach us at info@grzanglobal.com.