Chile Authorized Representative for Medical Devices

Local Regulatory Representation for Chile Market Entry

Chile Authorized Representative: Key Information

What Does “Authorized Representative” Mean in Chile?

The phrase is often used broadly in market-entry services. In Chile, it should be tied to the specific role required for the product.

 For medical devices, the ISP defines an Authorized Representative  or Holder as a natural or legal person established in Chile that has received and accepted a written mandate from a foreign legal manufacturer to act on its behalf for specified sanitary obligations. The medical-device sanitary registration is held in that local party’s name. 

For medicines and cosmetics, the relevant role may instead be the local registration holder, applicant or importer. The company’s required status and responsibilities depend on the applicable procedure. For example, the ISP’s cosmetics process requires the applicant to register as a holder in its GICONA system, while the ISP states that imported cosmetics must have a sanitary registration and the respective importer declared in it.

 The representative agreement should identify the products covered, the role the local company will take, and which party will hold each product authorization.

Local Representation Requirements Vary by Product

The ISP distinguishes product pathways within its systems and regulations. It also published Decree Exempt No. 25 of 2026, which brings specified medical devices and IVDs into Chile’s sanitary-control regime. Manufacturers should check whether a particular product is covered and review current ISP implementation guidance.

What Can a Chilean Representative Do?

The representative’s work should be defined in the appointment and service agreement. Depending on the product and the company’s role, the scope may include:

• Acting as the local applicant or holder: Submit or maintain the product authorization where the local company is named in the filing.
• Coordinating ISP submissions: Prepare and submit applications, changes or renewals through the applicable ISP process.
• Managing regulatory correspondence: Receive and coordinate responses to ISP questions and requests.
• Maintaining product records: Coordinate current product, manufacturer, importer and authorization information.
• Supporting import procedures: Coordinate local import requirements when the representative or a separately appointed importer performs that activity.
• Coordinating post-market matters: Help route product complaints, safety information and corrective-action communications to the responsible parties.
• Managing appointment changes: Coordinate applicable regulatory steps if the manufacturer changes its representative, holder or importer.

The exact duties vary by product category. The appointment should not imply that the representative takes over every responsibility of the manufacturer or importer.

Chile Representation and Regulatory Process

1. Confirm the product category and authority

Determine whether the product is a medicine, cosmetic, medical device, IVD or another regulated product. The category determines which ISP unit or other authority handles the matter and what type of local role is needed.

2. Identify the local applicant, holder and importer

Decide which Chilean entity will submit the application and whether it will also hold the authorization or carry out import activities. These roles may be held by the same company or divided among companies, subject to the applicable requirements.

3. Appoint the local party and document the scope

For medical devices, the ISP’s definition specifically calls for a written mandate accepted by a Chile-established representative or holder. For medicines and cosmetics, confirm the required applicant and holder arrangements for that product pathway.

4. Prepare category-specific documents

The documentation depends on the product. The parties may need to coordinate product information, manufacturer documents, certificates, labels, authorizations and evidence supporting the applicable application. Use the current ISP checklist for the relevant service.

5. Submit through the relevant ISP process

Medicines and cosmetics use ISP’s GICONA system for applicable procedures. The ISP is also progressively implementing SAFIS for certain authorizations and inspections, so check the current platform and instructions before filing.

6. Maintain the product authorization and local arrangements

After authorization, keep the product, holder, importer and representative information aligned with the actual commercial arrangement. Assess changes before implementation because a change to the holder or importer may require a formal ISP procedure.

How OMC Medical Can Support Your Chile Market Entry

OMC Medical can help manufacturers identify the appropriate Chilean representative arrangement and coordinate the regulatory work for their product category, including:

• List Item Product classification and pathway assessment
• Local applicant, holder and importer role review
• Representative appointment and document coordination
• ISP application and submission support
• Regulatory correspondence coordination
• Post-authorization change and compliance planning

Need a Local Regulatory Representative in Chile?

Start by confirming the product category and which local entity will act as applicant, holder or importer. OMC Medical can help map the appropriate next steps for your product.