Authorization of Use and Disposition (Uso y Disposición) in Chile

1. Key takeaways

The Authorization of Use and Disposition (Autorización de Uso y Disposición) is expressly required by Article 111(g) of the Sanitary Code and Article 27 of Decreto Supremo N° 825, de 1998: once controlled medical devices have entered Chile, their use and disposition must be authorized by the ISP. Together with the CDA it forms the two gates of customs clearance, and neither gate alone allows the goods to be released. A shipment that clears one gate but not the other is legally stranded: physically in the country, but not usable, not sellable and not distributable.

GRZAN summarizes the three instruments in one sentence: the registration certificate is the market access qualification; the CDA means this shipment may enter; the authorization of use and disposition means this shipment may be used. Keeping the three concepts distinct is the foundation of every import schedule, every release procedure and every compliance audit for a device business in Chile. When teams blur them, the typical symptom is inventory that sits in a warehouse while sales teams chase orders that cannot legally be fulfilled, because one of the three instruments was assumed to cover the others.

2. Legal basis

The following sources govern the authorization of use and disposition and its related obligations:

• Sanitary Code of Chile (Código Sanitario) | DFL N° 725, de 1967 | Article 111(g) | the customs destination of such devices is governed by Ley N° 18.164, and their use and disposition must be authorized by the ISP.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 27: the authorization of use and disposition.
• Same instrument | Article 25 | for repeated imports of the same product, the scope of verification is limited to confirming that the product is the same certified product.
• Same instrument | Article 30 | devices sold or distributed without a conformity verification certificate are seized.
• Regime of customs destination certificates for imported goods | Ley N° 18.164, de 1982 | 1982 | Article 2: establishes the CDA regime.

3. Expert insights

Insight 1: the three formalities sit at different legal levels and cannot replace one another.

The registration certificate derives from Article 111(a) of the Sanitary Code and the verification system of Decreto Supremo N° 825, de 1998; the CDA derives from Article 2 of Ley N° 18.164, de 1982; the authorization of use and disposition derives from Article 111(g) of the Sanitary Code and Article 27 of Decreto Supremo N° 825, de 1998. Three independent requirements, each indispensable. Because they originate in different instruments, obtaining one never streamlines the others procedurally, and assuming otherwise leads directly to stranded goods. Each instrument also expires or changes on its own calendar, which is another reason they must be tracked separately. Import planning should track the three as separate workstreams with separate completion criteria.

Insight 2: the authorization targets the holder/importer entity, which ties the holding structure directly to logistics.

If the license holder and the importer are separate companies, the question of who applies for the authorization of use and disposition, and to whom it is granted, becomes a design question that must be answered before the first shipment. This is precisely the technical reason why the earlier guidance recommends combining or binding the two roles. An authorization issued to one entity does not automatically serve a different entity handling the goods, and re-papering mid-shipment is not an option at the port. The structure decision made months before market entry shows up here, in the clearance queue, either as a smooth formality or as a multi-week delay.

Insight 3: the simplification logic of Article 25 applies here as well.

For repeated imports of the same certified product, the scope of verification is limited, unless the inclusion decree requires per-batch verification. But the precondition for the simplification is that the product information is completely identical: any change in model, packaging or manufacturer data may lead the ISP to require renewed verification. Teams should treat document consistency as an import-cost lever: the cleaner the match between labels, commercial documents and the certificate, the fewer shipments fall out of the simplified path and into full verification with its associated delays.

Insight 4: selling before the authorization is complete triggers seizure.

Article 30 of Decreto Supremo N° 825, de 1998 provides for seizure where devices are sold or distributed without a conformity verification certificate. Goods sitting in a warehouse are not therefore free to sell: if the authorization of use and disposition has not been completed, dispatching the goods creates immediate risk in the distribution channel. The enforcement action lands on stock that has already left the warehouse, on customers who have already received it, and on the sales records that prove it happened. No commercial pressure justifies releasing a batch ahead of the authorization, because the downside is not a fine but the loss of the goods themselves. The enforcement file does not ask whether the goods were good; it asks whether the paper trail was complete.

4. Practical recommendations

1. Make the three complete documents the precondition for release: registration certificate + CDA + authorization of use and disposition; if one is missing, the goods do not move.
2. Set a release block in the ERP or WMS, so that batches whose authorization has not been confirmed never enter sellable inventory.
3. Keep the imported product information identical to the registration, so that the Article 25 simplification can apply.
4. Archive records per shipment: authorization number, batch number, release date and consignee, forming a continuous traceability chain.
5. Re-verify the authorized entity whenever the channel changes, so that a mismatch between license holder and importer never stalls the authorization.

5. Verification checklist

• □ The authorization requirement of Article 111(g) of the Sanitary Code and Article 27 of Decreto Supremo N° 825, de 1998 has been confirmed
• □ The release process enforces the three-complete-documents block
• □ The imported product information is identical to the registration content
• □ A per-shipment authorization archive and traceability chain has been established
• □ The authorized entity has been checked for consistency when the distribution channel changes

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, use-and-disposition authorization processing for every shipment, and fee and budget planning under the current ISP arancel. Whether you need a release-process review, 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.