The Authorized Representative Chain: Written Delegation Requirements in Chile

1. Key takeaways

Under Chilean law, the authorized representative (representante autorizado) or license holder (titular) is defined as a natural person or company established in Chile that accepts and holds the written delegation of a foreign manufacturer and holds the sanitary registration of the device in its own name. This definition comes from ISP technical guidance ANDID/024. Three elements matter equally: establishment in Chile, a written delegation, and holding the registration in the delegate’s own name. Remove any one of them and the entity in question is not, in the eyes of the ISP, a valid representative of the foreign manufacturer.

GRZAN draws the authorization chain as five links: manufacturer → written power of attorney (notarized + Apostille) → the license holder accepts the delegation → GICONA filing in the license holder’s name → the registration certificate lands in the license holder’s name. The chain is only as strong as its weakest link, and any missing link causes the entire chain to break at the deficiency stage of review. Because the deficiency window is short, a broken chain discovered late can cost weeks of queue position.

2. Legal basis

The following sources define the representative and the delegation requirements:

• ISP technical guidance | ANDID/024 | definition of the authorized representative or license holder: a natural person or company established in Chile that has accepted the written delegation of a foreign manufacturer and holds the sanitary registration of the device in its own name.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 3: entities that manufacture, import, sell or distribute controlled devices must obtain a prior conformity verification certificate; Article 2, numeral 13: definition of the manufacturer (the entity that commercializes the product under its own name).
• ISP procedure | prestación 9100003 (v3, September 25, 2025) | requires a letter from the manufacturer acknowledging the applicant as its authorized representative or distributor (not required for local manufacturers), which must be authenticated or Apostilled.
• Sanitary Code of Chile (Código Sanitario) | DFL N° 725, de 1967 | Articles 111(a) and 111(g) | control and certification procedures; authorization of use and disposition.

3. Expert insights

Insight 1: the core of the delegation is that it is written, and the written document must be authenticated.

Both the definition in ANDID/024 and the procedural requirements point to a written delegation. It must be notarized and Apostilled, and Chile is a party to the Hague Apostille Convention, so no consular legalization layer is needed beyond the Apostille. An oral arrangement or an authorization by email does not constitute a compliant delegation, and this is the most common break at the very first link of the chain. Manufacturers discover it at the worst possible moment: after the dossier is submitted, when the ISP requests the authenticated document and the response clock is already running. Preparing the notarized and Apostilled power of attorney before drafting anything else in the dossier is the cheapest insurance available in this process. The same document is re-examined at every later step, from change filings to holder transfers, so the investment in getting it right compounds over the life of the registration.

Insight 2: the power of attorney must cover ongoing duties, not only the filing.

Many powers of attorney say only that a company is authorized to apply for registration on behalf of the manufacturer. But the duties of a license holder extend to change filings, technical vigilance reporting, recall execution and renewal matters. If the power of attorney does not cover these acts, each of them will require fresh documentation later, and each new authentication cycle takes weeks. The economically rational approach is to draft one comprehensive instrument covering the full lifecycle of the registration, even if it takes slightly longer to negotiate up front. The alternative is paying for the same notarization and Apostille repeatedly, always at an inconvenient time.

Insight 3: the identity of the delegating party must match the manufacturer of record.

Article 2, numeral 13 of Decreto Supremo N° 825, de 1998 defines the manufacturer as the entity that commercializes the product under its own name. If the delegating party is a trading company rather than the legal manufacturer, the ISP will question the starting point of the authorization chain. Group structures with multiple plants deserve particular care: the delegating party on the power of attorney must match the manufacturer named in the filing documents, down to the specific legal entity. A mismatch between the group parent named in the delegation and the plant named in the technical file is exactly the kind of inconsistency that generates a deficiency notice. The check is mechanical, but skipping it is the single most expensive shortcut in the dossier.

Insight 4: changing the license holder is a formal procedure, not a private handover.

Replacing a license holder requires a new power of attorney from the manufacturer and a change procedure before the ISP. The value of a transfer-upon-demand clause is precisely that it converts this step into an enforceable obligation rather than a matter of commercial goodwill. Without such a clause, an incumbent license holder who is unhappy about losing the business can simply decline to cooperate, and the manufacturer is left with a registration it cannot move. With one, the handover becomes a contractual duty whose breach has consequences a Chilean court can enforce.

4. Practical recommendations

1. Draft the power of attorney completely in one pass: cover the five categories of acts, namely filing, changes, technical vigilance, recalls and renewal matters.
2. Complete notarization and the Apostille in one round, and keep a Spanish-language translation on file.
3. Verify that the delegating party matches the legal manufacturer in the filing documents; for groups with multiple plants, specify the exact legal entity.
4. Write transfer-upon-demand and termination handover clauses into the distribution agreement, and have Chilean counsel confirm enforceability.
5. Reserve a time window in the power of attorney for holder changes, so that a channel transition never coincides with a gap in the registration.

5. Verification checklist

• □ A written power of attorney from the manufacturer has been obtained, notarized and Apostilled
• □ The power of attorney covers filing, changes, technical vigilance, recalls and renewal matters
• □ The delegating party matches the legal manufacturer in the filing documents
• □ A Spanish-language translation has been attached
• □ The agreement contains transfer-upon-demand and termination handover clauses

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 (titular) and importer setup, power of attorney preparation with notarization and Apostille, and fee and budget planning under the current ISP arancel. Whether you need an authorization chain 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.