Chile Device Access: Conformity Verification vs Sanitary Registration Explained

1. Key takeaways

Device market access in Chile is a two-level structure: conformity verification (verificación de la conformidad) answers whether the product meets applicable standards, while sanitary registration (registro sanitario) answers whether the product may be manufactured, imported, sold or distributed in Chile. For the categories newly brought in by Exempt Decree No. 25/2026, conformity verification takes the form of sanitary registration, implemented by the ISP through a documentary review.

The practical consequence is that companies face neither a two-stage process of first finding a third-party verifier and then applying for official registration, nor a split of responsibility between two institutions. Instead, the ISP completes the work in one pass: it acts simultaneously as the verification body and as the issuing authority. Everything — the standard applied, the evidence reviewed and the certificate granted — sits inside a single ISP procedure, and the entire workload therefore concentrates on assembling a documentary evidence package that can survive that single review. Scheduling, budgeting and internal sign-offs should all be built around that single-pass reality from day one.

2. Legal basis

• Sanitary Code | DFL N° 725, de 1967 | Article 111, subparagraph a) | manufacturing, import, sale or distribution must have quality control and certification performed by institutions expressly authorized in sanitary matters by the ISP.
• Same instrument | Article 111, subparagraph b) | the ISP authorizes and supervises the institutions engaged in control and certification; where no private bodies exist to carry out those tasks, the ISP implements them itself.
• Same instrument | Article 111, subparagraph c) | control and inspection follow Chilean official standards (INN, approved by the Ministry of Health), and where none exist, the standards approved by the Ministry of Health apply.
• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | 21 August 1999 | Article 3: a conformity verification certificate must be obtained in advance; Article 1: without such a certificate, manufacture, import, sale or distribution is prohibited.
• Bringing the listed devices under the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | 19 March 2026 | for the newly listed categories, conformity verification is realized in the form of a sanitary registration granted by the ISP, evaluating quality, safety and performance evidence through documentary review.

3. Expert insights

Insight 1: the two levels are separate in the statute but merged in current practice.

Article 111, subparagraphs a) and b) presuppose a model of private verification bodies supervised by the ISP, and it is the proviso in subparagraph b) that allows the ISP to step in directly. Exempt Decree No. 25/2026 makes the situation explicit: there are currently no accredited private conformity verification bodies for the newly listed categories, and verification is implemented directly by the ISP. This is the real-world trigger of the subparagraph b) proviso, not a failure of the system. Companies should therefore stop designing processes around a third-party verifier that does not yet exist. Should accredited private bodies appear in the future, the statutory model can shift back; until then, every plan should assume ISP-only handling and a correspondingly concentrated review calendar.

Insight 2: verification is documentary review, which makes documentation engineering the main workload.

Documentary review means the ISP does not redo design verification; it assesses whether the evidence submitted by the company demonstrates compliance with standards such as NCh-ISO 16142-1/2. Two corollaries follow. First, foreign test reports can be accepted, provided they are traceable and properly authenticated. Second, the way the documentation is organized matters more than the number of reports: a compact, standards-mapped evidence package reads better to a reviewer than a thick, unmapped pile. Budget accordingly — the highest-leverage work in a Chilean project is the architecture of the evidence file, not additional testing.

Insight 3: the verification standards are layered — general principles first, product-specific standards second.

Article 111, subparagraph c) of the Sanitary Code establishes the order of preference for Chilean official standards. Exempt Decree No. 25/2026 translates that order into concrete standards: the general NCh-ISO 16142-1/2 (essential principles of safety and performance), NCh-ISO 13485 (quality management systems) and NCh-ISO 14971 (risk management), with the product-specific standards listed in the schedule stacked on top. Map your evidence to each layer in sequence.

Insight 4: once the two levels are merged, the appeal path also needs to be understood clearly.

Article 6 of DS 825/1998 provides that where a device fails verification by an authorized body, a written appeal may be filed with the ISP within 15 business days from the date of notification, and Article 7 requires the contested body to submit its explanation and all materials within 10 business days. When the ISP itself is the verification body, these two articles operate as an internal review path. Knowing the clock in advance is the only way to use it.

4. Practical recommendations

1. Organize documentation around a single submission: do not schedule two separate phases of verification and registration; prepare one complete file package for the ISP’s single review.
2. Map evidence against the three-layer standard system: NCh-ISO 16142-1/2 as the general frame, then NCh-ISO 13485 and NCh-ISO 14971, then product-specific standards, layer by layer.
3. Preserve the original provenance of foreign test reports: documentary review depends on traceability, and every report must lead back to its issuing laboratory and the standard version applied.
4. Know the appeal deadlines: start the 15-business-day clock on the day the adverse notice arrives, and set the internal finalization milestone at business day ten.

5. Verification checklist

• □ The two-level structure and the current reality of the ISP holding both roles have been understood
• □ A complete file package has been organized around a single submission
• □ An evidence mapping table against the three-layer standard system has been established
• □ Foreign test reports have been confirmed as traceable to the issuing body and standard version
• □ The 15-business-day appeal deadline has been written into the quality event procedure

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Chilean market with ISP registration pathways and classification strategy, including evidence mapping against the NCh-ISO standard hierarchy. For a feasibility assessment of your specific product, contact the GRZAN regulatory team at info@grzanglobal.com.