Medical Device Background Review in Chile: When Does It Add Value to Market Entry?

Not all medical devices are currently subject to mandatory health registration in Chile. For companies seeking to enter this market, a Background Review by the Chilean Institute of Public Health (Instituto de Salud Pública de Chile, ISP) may support a product’s quality, safety, and performance credentials before importers, distributors, or buyers, provided that it serves a defined regulatory and commercial objective.

 

A Different Route from Mandatory Health Registration

Exempt Decree No. 25/2026 expanded the range of medical devices and in vitro diagnostic medical devices that will be subject to health registration in Chile. In our previous analysis, we explained the 39 categories introduced, the 24- and 36-month timelines, and the preparations required for future registration.

This article addresses the complementary question: what option is available when a product belongs neither to a category currently under mandatory control nor to one of the categories introduced by the decree?

In this scenario, companies may assess ISP service code 9100002, officially named “Revisión de los antecedentes que acompañan al dispositivo médico” (Review of the Supporting Documentation Accompanying a Medical Device). Applications are submitted through Form ANDID/001. This route is not equivalent to health registration, but it may provide useful evidence for market access.

 

What Is the ISP Background Review?

Through this procedure, the ISP examines the documentation submitted to support the quality, safety, and performance of a medical device that is not subject to mandatory health control. The authority may then issue the corresponding Background Review Certificate.

The ANDID/001 instructions cover identification of the applicant —a domestic manufacturer or importer— as well as the product’s technical and administrative information. Before filing, the company should also confirm its registration with the ISP and verify consistency among the product, manufacturer, and supporting documentation.

What the Certificate May Demonstrate

The certificate confirms that the ISP reviewed the documentation accompanying the product within the scope of the application. For commercial partners or institutional buyers, it may provide support from the Chilean health authority regarding the documentation assessed.

What the Certificate Does Not Replace

The Background Review is not a voluntary health registration and does not convert the product into a device subject to registration. Nor does it replace other import authorizations, establishment requirements, commercialization conditions, or technical obligations that may apply. Its scope must be communicated accurately so that the certificate is not presented as a broader approval than it actually represents.

 

When Can It Create Regulatory and Commercial Value?

Applying for the certificate makes sense when it addresses a specific need. It should not be pursued merely to accumulate documentation, but as part of a regulatory affairs strategy connected to the market-entry channel and business model.

Assessment by Distributors and Importers

A prospective local partner may require additional evidence before adding a product to its portfolio. The certificate can strengthen due diligence, facilitate the distributor’s internal review, and reduce uncertainty about the adequacy of the technical documentation supplied by the manufacturer.

Participation in Public Tenders

Some tender specifications may request or assign value to a Background Review Certificate. In these cases, having the document may contribute to the admissibility or scoring of a bid, depending on the procurement rules. It does not, however, create an automatic advantage: each tender must be assessed individually, and the certificate does not guarantee an award.

Preparation for Future Regulatory Expansion

The document review may also reveal gaps that should be corrected before the category becomes subject to additional controls. Although the certificate will not replace a future health registration, early assessment of the evidence can improve understanding of the file and guide the preparation of supplementary documentation.

 

Three Questions for Selecting the Correct Regulatory Route

The decision should begin with an applicability assessment, rather than with the premature selection of a procedure:

1. Is the device in a category currently subject to mandatory health registration? If so, the applicable registration route should be followed; the Background Review cannot be used as a substitute.
2. Is the product included among the categories covered by Exempt Decree No. 25/2026? If so, the company should determine its effective date, monitor the technical instructions, and assess a future voluntary registration application.
3. Is the product outside both groups? The company may then evaluate whether a Background Review is appropriate, considering its commercial objective and all other applicable requirements.

This sequence helps avoid two common errors: attempting to register a product that is not yet under mandatory control or seeking an administrative certificate to cover a registration obligation that is already enforceable.

 

What Should Be Reviewed Before Filing Form ANDID/001?

The documentation should describe the same product and present a coherent technical narrative. A preliminary assessment should cover:

• Precise identification of the device, including models, variants, and accessories.
• Intended use, indications, target population, and operating principle.
• Identification of the manufacturer, manufacturing sites, and relationship with the applicant importer.
• Risk classification and regulatory status in the country of origin or reference markets.
• Quality, safety, and performance evidence applicable to the device type.
• Certificates, test reports, risk management documentation, labeling, and instructions for use.
• Consistency among trade names, codes, versions, and documents in the file.

The availability of documents alone does not ensure a robust submission. Regulatory intelligence helps assess their relevance, validity, traceability, and correspondence with the configuration that will actually be marketed in Chile.

 

From an Isolated Procedure to a Market-Access Decision

For regulatory affairs managers, business development managers, and commercial managers, the relevant question is not simply whether the certificate can be obtained, but which business decision it will support.

Before applying, the company should determine who will submit the request, which buyer or channel values the certificate, whether there is a target tender, how long the submitted documentation will remain current, and which product changes could affect its usefulness. It should also confirm that the selected distributor has the operational and regulatory capabilities required to import and commercialize the device.

The Background Review can therefore become part of a roadmap connecting the product, local partner, commercial channel, technical documentation, and regulatory developments. This is the contribution of regulatory intelligence: turning fragmented information into a market-entry decision with defined responsibilities, sequencing, and risk criteria.

 

Conclusion: Its Value Depends on the Strategy It Supports

The Background Review Certificate can be valuable for certain medical devices that do not require mandatory health registration, particularly when it strengthens a distributor’s assessment, addresses a procurement requirement, or improves technical support before institutional customers. Its usefulness, however, depends on the product’s scope, the commercial objective, and a correct interpretation of its limitations.

 

At SCR Consulting, we help navigate regulatory risks and determine whether the Background Review is the appropriate route for each product. Through our regulatory intelligence and regulatory affairs services, we assess applicability, review documentation, and align the technical strategy with commercial entry. With a presence in Peru, Bolivia, and Chile, we are strategic partners to medical device companies that need to make regional decisions supported by local expertise. Contact us to evaluate the most appropriate route for your portfolio in Chile.

 

Sources and Related Links

• Chilean Institute of Public Health: Health registration of medical devices and IVD medical devices.
• Chilean Institute of Public Health: Instructions for Form 9100002 ANDID/001.
• SCR Consulting: Exempt Decree No. 25/2026 and health registration for 39 medical device categories.