Chilean Entity Setup for Medical Devices: RUT, Company Registration and Warehouse

1. Key takeaways

Before any product submission, the Chilean entity must complete three steps in order: obtain the Chilean tax number (RUT), complete the company registration (Inscripción de Empresa, registered as a medical device manufacturer, importer or distributor), and obtain the warehouse authorization (Autorización de Bodega). The competent authority for the third step is the SEREMI de Salud of the region where the warehouse is located, or the ISP; the authorization result is entered into GICONA, and every CDA must name this warehouse as the destination warehouse.

GRZAN’s scheduling principle is that these three steps run in parallel with product documentation engineering, but a blockage in any one of them stalls the opening of the GICONA account. The sequence among the three steps is also fixed and cannot be reordered: the tax number precedes company registration, and company registration precedes warehouse authorization and platform access. Plan the chain once and follow it strictly. In project reviews, the status of these three steps is reported alongside dossier status, because a finished dossier sitting behind an unfinished entity setup delivers no market access at all.

2. Legal basis

• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | 21 August 1999 | Article 3: entities engaged in the manufacture, import, sale or distribution of controlled devices must first obtain a conformity verification certificate.
• Sanitary Code | DFL N° 725, de 1967 | Article 111, subparagraph e) | SEREMI handle case filing and sanctions within their jurisdictions (the enforcement basis for warehouse inspections).
• Same instrument | Article 111, subparagraph g) | the customs purpose of devices follows Law No. 18.164, and use and disposal require ISP authorization.
• Regime of customs clearance certificates for imported goods | Ley N° 18.164, de 1982 | 1982 | Article 2: the CDA regime.
• ISP submission requirements | GICONA platform | submissions require a Chilean tax number, prior company registration and a registered warehouse; the technical vigilance contact person must be designated at company registration.

3. Expert insights

Insight 1: warehouse authorization is address-bound, and changing warehouses means running the process again.

The authorization points to a specific address, and every CDA names that warehouse as the destination. Changing warehouses is not an internal administrative change; it requires a new authorization and a new system registration. GRZAN recommends evaluating three things together at site selection: capacity, temperature control and cold-chain capability, and the inspection rhythm of the local SEREMI. Choosing well the first time avoids repeating an administrative cycle that can otherwise idle an entire market-entry schedule. For products with strict temperature requirements, the cold-chain record should be demonstrated during the authorization visit itself, not promised in a procedure document.

Insight 2: the technical vigilance contact person must be designated at company registration.

The ISP requires the designation at the company registration stage, which means preparation for post-market obligations is pulled forward into the market-access phase. Many companies only think about this after receiving the certificate, by which time the field in the system has been left empty. Appointing the officer and deputy early, with appointment documents retained, also gives you a working escalation line from the very first inspection. The officer should have direct access to the manufacturer’s complaint and field-action processes, because the quality of vigilance reporting depends on how fast information crosses the manufacturer-holder boundary.

Insight 3: the SEREMI is both the authorizing body for warehouses and the inspection body.

This is consistent with Article 111, subparagraph e): authorization and enforcement sit at the same level. Temperature and humidity records, batch traceability and segregation areas for nonconforming products are reviewed items at authorization and inspected items afterwards. Preparing once against the same standard saves an entire round of corrective action, because anything a SEREMI inspector flags during routine visits would otherwise surface again at renewal or post-market inspection. The practical rule is that no record format should exist only for the authorization day — every record the warehouse produces must be sustainable as a daily routine.

Insight 4: the order of the three steps cannot be inverted.

The tax number is the prerequisite for the entity’s legal identity; company registration needs the tax number and a legal representative; warehouse authorization and GICONA user registration depend on company registration. GRZAN draws this chain as a one-way pipeline at every project kickoff meeting to prevent parallel-planning errors, because teams that try to start two steps simultaneously usually discover the dependency only when a form is rejected for a missing predecessor.

4. Practical recommendations

1. Schedule in the irreversible order: tax number → company registration (including the technical vigilance contact) → warehouse authorization → GICONA user registration.
2. Get the warehouse site right the first time: evaluate capacity, cold chain, segregation areas and SEREMI inspection requirements together to avoid repeating the process for a warehouse change.
3. Fix the technical vigilance officer and deputy at the company registration stage and retain the appointment documents.
4. Prepare the warehouse to the rule of authorization standard equals inspection standard: temperature and humidity records, batch traceability and nonconforming-product segregation built once.
5. Mark the completion dates of the three steps as the earliest possible product submission date and enter them into the project gantt chart.

5. Verification checklist

• □ The Chilean tax number (RUT) has been obtained and the legal representative confirmed
• □ Company registration has been completed, with the registered scope covering the relevant manufacture, import and distribution activities
• □ The technical vigilance contact person was designated at company registration
• □ Warehouse authorization has been obtained and entered into GICONA
• □ The warehouse record system has been prepared to the same standard for authorization and inspection

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Chilean market with ISP registration pathways and classification strategy, including entity setup, warehouse authorization and GICONA onboarding. For a feasibility assessment of your specific product, contact the GRZAN regulatory team at info@grzanglobal.com.