License Holder and Importer Separation: Four Points of Lost Control in Chile

1. Key takeaways

Chilean law does technically allow the license holder (titular) and the importer to be designed as two separate entities. GRZAN does not recommend this structure. The reason is operational rather than legal: every shipment of controlled medical devices into Chile requires a CDA (Certificado de Destinación Aduanera, the customs destination certificate) together with an Authorization of Use and Disposition (Autorización de Uso y Disposición), and both instruments point directly at the license holder and importer entity. When those roles are split across companies and the authorization chain between them is unclear, the structure creates four distinct points of lost control: a break in customs clearance, loss of control over the technical file, the sidelining of change-notification rights, and the collapse of post-market obligations.

The practical consequence of each failure point is asymmetric. The importer or license holder controls the procedural levers, while the manufacturer carries the commercial damage when those levers are not pulled. A shipment that arrives at a Chilean port with paperwork nobody can act upon, a technical file effectively held hostage after a partnership ends, a product improvement that can never be reflected in the registration because the application right sits with a third party, and a recall that cannot be executed because the local entity refuses to cooperate: these are the four scenarios that a poorly designed holding structure makes possible. In each of them, the party with the weakest contractual position is the one that loses the most.

The structures GRZAN recommends are, in descending order of preference: merging the license holder and importer into a single entity, or binding the license holder to an exclusive importer under a contract that makes transfer and cooperation obligations enforceable before Chilean courts. Either option keeps the authorization chain short enough to survive contact with customs, with the ISP, and with a dispute.

2. Legal basis

The following instruments define the obligations that make holder–importer separation risky. Citations are reproduced exactly as they appear in the Chilean sources:

• Sanitary Code of Chile (Código Sanitario) | DFL N° 725, de 1967 | Article 111(g) | the customs destination of controlled 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 3: the manufacture, import, sale and distribution of controlled devices require a prior conformity verification certificate; Article 27: the authorization of use and disposition.
• Same instrument | Article 28 | post-market reporting obligations (reciprocal reporting duties for healthcare institutions and for importers/manufacturers).
• Regime of customs destination certificates for imported goods | Ley N° 18.164, de 1982 | 1982 | Article 2: establishes the CDA regime.
• ISP technical guidance | ANDID/024 | the definition of the authorized representative or license holder presupposes a written delegation from the foreign manufacturer.

3. Expert insights

Insight 1: the first point of lost control is a break in customs clearance.

Once goods arrive at port, the entity named in the CDA and in the authorization of use and disposition must be identifiable and must match whoever actually performs the clearance. If the license holder and the importer are separate and the authorization chain between them is not airtight, the shipment can arrive and nobody is in a position to complete the release formalities. The goods sit in the port while the two companies work out who signs what. Port demurrage and storage charges accumulate daily and typically far exceed the official registration fees (practical estimate). A clearance break of even a few weeks can consume the entire commercial margin of the affected batch, and for temperature-sensitive products the exposure is worse still.

Insight 2: the second point of lost control is the technical file.

Technical documentation is normally produced and owned by the manufacturer, but it is the license holder that submits it to the ISP as part of the filing. If the agreement does not stipulate ownership, return and handover obligations for the technical file, the manufacturer may be unable to recover its own documents after the cooperation ends, and equally unable to transfer them to a new license holder. Every re-filing then starts from zero. This is not a theoretical concern: termination disputes are precisely when cooperation is at its lowest and the document holder has the most leverage. The fix belongs in the contract, negotiated while both parties are still on good terms, not in a demand letter sent after the relationship has already broken down.

Insight 3: the third point of lost control is the right to file changes.

Exempt Decree N° 25/2026 provides that major changes require a new registration application. The application right belongs to the license holder. A manufacturer can complete a product improvement in its own factory, and yet have no procedural means to reflect that improvement in the Chilean registration if the license holder declines to file. Over time, the certificate and the physical product drift apart. The registration then describes a device that no longer exists, which is both a compliance problem and an evidentiary liability in any future inspection, complaint or recall scenario.

Insight 4: the fourth point of lost control is the collapse of post-market obligations.

Technical vigilance reporting, recall execution and cooperation with inspections all rest on the local entity. When the license holder does not cooperate, the manufacturer cannot perform these duties on its own, but the consequences (a suspended registration, an interrupted distribution channel) land on the manufacturer. Article 28 of Decreto Supremo N° 825, de 1998 confirms that post-market reporting is a live obligation, not a formality, and it runs in both directions between healthcare institutions and importers/manufacturers. A structure in which the duty-bearer and the duty-payer are different companies converts every post-market event into a negotiation.

4. Practical recommendations

1. Prefer a structure in which the license holder and the importer are the same entity; the second-best option is a binding exclusive importer arrangement with enforceable cooperation clauses.
2. Write a transfer-upon-demand clause into the agreement, and have Chilean counsel confirm that it is enforceable in practice, not only on paper.
3. Stipulate ownership, return and handover obligations for the technical file, so that the manufacturer can recover the complete file when the cooperation ends.
4. Agree on a cooperation deadline for change filings: once the manufacturer initiates a change, the license holder completes the filing within the agreed number of days.
5. Agree on a deadline for exchanging technical vigilance information, so that the manufacturer can meet its own reporting duties without depending on goodwill.

5. Verification checklist

• □ The structure of the license holder and importer has been decided (combined or bound)
• □ The agreement contains a transfer-upon-demand clause
• □ The agreement defines ownership, return and handover of the technical file
• □ The agreement sets a cooperation deadline for change filings
• □ The agreement sets a deadline for exchanging technical vigilance information

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 structure, CDA and use-and-disposition processing, and full fee and budget planning under the current ISP arancel. Whether you need a structure 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.