Warehouse Authorization (Autorización de Bodega) for Device Imports in Chile

1. Key takeaways

To import controlled medical devices into Chile, the warehouse must first hold a Warehouse Authorization (Autorización de Bodega). The competent authority is usually the SEREMI de Salud of the region where the warehouse is located, or the ISP. The authorization outcome is recorded in GICONA, and every CDA names this warehouse as its destination warehouse. In other words, warehouse authorization is not a separate, optional compliance step: it is a precondition that is wired directly into the customs paperwork for every single shipment.

The GRZAN observation that saves clients money is this: the authority that grants the warehouse authorization and the authority that inspects the warehouse are the same tier of SEREMI (Article 111(e) of the Sanitary Code). Therefore preparing to the standard that the authorization will be judged against, and keeping that standard for inspections, eliminates one round of corrective work. Companies that build two parallel standards, a minimal one for the application and a defensive one for inspections, inevitably end up retrofitting the warehouse after the first SEREMI visit, at a cost that a single well-planned setup would have avoided.

2. Legal basis

The following sources govern warehouse authorization and the obligations attached to it:

• Sanitary Code of Chile (Código Sanitario) | DFL N° 725, de 1967 | Article 111(e) | for violations of the provisions of Article 111, the SEREMI of the region where the violation occurred is responsible for opening the case and imposing sanctions.
• Same instrument | Article 111(g) | the customs destination of devices is governed by Ley N° 18.164; their use and disposition must be authorized by the ISP.
• Regime of customs destination certificates for imported goods | Ley N° 18.164, de 1982 | 1982 | Article 2: establishes the CDA regime.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 21(a), point 3: storage conditions; Article 3: the prior verification obligation for entities handling controlled devices.
• ISP filing requirements | GICONA | the warehouse must be registered in the system, and the CDA names that warehouse as the destination warehouse.

3. Expert insights

Insight 1: the warehouse authorization is bound to the address, so changing warehouses means restarting the process.

The authorization points to a specific address, and the destination warehouse on every CDA is that address. Changing warehouses is not an internal administrative change: it requires a new authorization and a new system registration, and until both are in place no CDA can name the new site. GRZAN therefore advises evaluating capacity, temperature control and cold chain, and quarantine areas for nonconforming products at the site-selection stage, before signing any lease. A warehouse that is cheap because it lacks cold-chain infrastructure is expensive once the project must either retrofit it or move again, and each move restarts the authorization clock. A move that begins before the replacement authorization is granted leaves the new site legally unable to receive controlled goods, and every day of that gap is a day of frozen inventory.

Insight 2: the SEREMI is both the issuing authority and the inspection authority.

Article 111(e) of the Sanitary Code assigns the power to open cases and impose sanctions to the SEREMI of the region where the violation occurred. This means the warehouse must pass the authorization review and must also withstand later inspections by the same tier of authority. Preparing to a single standard, the stricter of the two, is the most cost-efficient approach. The records that satisfy the authorization reviewer are precisely the records that satisfy the inspector, so building one consistent record system avoids the classic failure pattern of an application that passed but a facility that cannot evidence what it promised.

Insight 3: warehouses for cold-chain products face significantly higher requirements.

Exempt Decree N° 25, de 2026 brought in a large number of IVDs, including respiratory virus tests and blood glucose monitoring products, many of which carry storage temperature requirements. The warehouse temperature and humidity records, together with deviation handling records, are the documents most frequently requested during inspections. Continuous monitoring with alarms, calibrated sensors and documented deviation investigations should be treated as the baseline for any warehouse that will hold cold-chain devices, not as an enhancement added after the first inspection finding.

Insight 4: the warehouse is the physical site where seizure is executed.

Article 111(f) of the Sanitary Code and Article 30 of Decreto Supremo N° 825, de 1998 provide that devices sold or distributed without a certificate are seized. Seizure typically takes place at the warehouse or in the distribution channel, not at the manufacturer’s premises. The warehouse batch traceability records therefore determine whether a seizure can be limited to specific affected batches or must extend to the entire stock. A warehouse that cannot link incoming shipments, storage locations and outgoing sales by batch number exposes every product it holds to the enforcement action, not just the affected lot. The distinction matters commercially: a scoped seizure is a logistics incident, while an unscoped one is a supply crisis.

4. Practical recommendations

1. Get the warehouse site selection right the first time: evaluate capacity, temperature control and cold chain, quarantine areas for nonconforming products, and SEREMI inspection expectations together.
2. Build the record system to the standard that authorization will be judged against, and keep it for inspections: temperature and humidity records, deviation handling, batch traceability and quarantine ledgers.
3. Equip cold-chain products with continuous temperature monitoring and alarm mechanisms, and retain calibration records.
4. Establish batch traceability, so that during an inspection the problem can be confined to specific batches instead of the whole warehouse being seized.
5. Start the new authorization process well before moving warehouses; do not wait until the old warehouse is due to expire.

5. Verification checklist

• □ The warehouse authorization has been obtained and recorded in GICONA
• □ The warehouse maintains temperature and humidity records and deviation handling records
• □ Cold-chain products have continuous temperature monitoring with calibration records retained
• □ A batch traceability ledger has been established
• □ A quarantine area for nonconforming products exists with its own ledger

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Chilean market with end-to-end services covering the local license holder and importer setup, warehouse authorization under the Autorización de Bodega regime, and fee and budget planning under the current ISP arancel. Whether you need a site-readiness assessment, a cost model for your product class, or hands-on filing support through GICONA, our regulatory team is ready to help. Contact us at info@grzanglobal.com.