Medical Device and IVD Definitions Under DS 825/1998

1. Key takeaways

The statutory definition of a medical device in Chile is found in Article 2 numeral 1 of DS 825/1998, aligned with the GHTF/IMDRF approach: software is included, the principal intended action is not achieved by pharmacological, immunological or metabolic means (although such means may assist), and the uses cover diagnosis, prevention, monitoring, treatment or alleviation, investigation, replacement or modification of anatomical or physiological processes, and fertility regulation. The definition of in vitro diagnostic devices (IVDs) sits in Article 2 numeral 2, whose core is examination of specimens of human origin, including blood and tissue donations, performed outside the body.

The GRZAN judgment is that definition determination must precede classification determination. Most disputes that present themselves as classification disputes are in fact extensions of definition disputes — debating whether a product is a Class I or Class III device before settling whether it is a device at all, or an IVD at all, is an ordering error that contaminates every downstream step.

2. Legal basis

• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 2 numeral 1: definition of medical device or medical article (including software; principal intended action not pharmacological, immunological or metabolic; list of uses).
• Same source | Article 2 numeral 2: definition of in vitro diagnostic medical device (reagents, calibrators, control materials, equipment, instruments, apparatus or systems; examination of specimens of human origin performed outside the body).
• Same source | Article 2 numerals 3 to 5: transient use (continuous use for less than 60 minutes), short-term use (continuous use for not more than 30 days), long-term use (continuous use for more than 30 days).
• Same source | Article 2 numeral 8: definition of implantable device (wholly introduced into the human body, or replacing an epithelial or ocular surface by surgical intervention and remaining in place after the procedure; or partially introduced into the body by surgery and remaining in place for at least 30 days).
• Same source | Article 2 numeral 13: definition of manufacturer (the natural or legal person responsible for design, manufacture, packaging and labeling who commercializes the device under its own name).
• Same source | Article 2 numeral 14: intended use (the use indicated by the manufacturer on the label, in the instructions for use and/or in promotional material).

3. Expert insights

Insight 1: software has been inside the definition text since 1998; it is not a recent addition.

Article 2 numeral 1 expressly contains the phrase incluyendo software. This explains why the Decreto Exento N° 25, de 2026 could add medical device software (SaMD) for oncology image processing, analysis and treatment planning to the list without amending the law: the definition covered software long ago, and what was missing was only the inclusion decree. Any argument that software sits outside the Chilean device regime is textually untenable.

Insight 2: three time thresholds are the hidden levers of classification.

60 minutes (transient use), 30 days (the boundary between short-term and long-term use) and 30 days (the minimum retention period for implantable devices) directly determine which band an invasive device falls into. GRZAN recommends stating the expected duration of continuous use explicitly in the product technical description, so that reviewers do not have to infer it, since a self-inferred duration almost always lands in the more conservative band.

Insight 3: intended use is indicated by the manufacturer, which makes it both a right and a responsibility.

Article 2 numeral 14 anchors intended use in what the manufacturer indicates on the label, in the instructions for use and/or in promotional material. Promotional material therefore becomes a regulated source of evidence. The common practice among some manufacturers of writing broadly in trade-fair materials and narrowly in registration dossiers creates a direct evidentiary conflict in Chile, and inconsistencies between the two sets of documents can undermine the submission itself.

Insight 4: the IVD definition includes compatibility determination, covering blood grouping and matching reagents.

The list of uses in Article 2 numeral 2 expressly includes determining safety and compatibility with potential recipients. This is the definitional basis on which immunohematology reagents are brought into the controlled list, and it should be cited in the definition determination document for any blood banking product.

The ordering discipline matters as much as the definitions themselves. Article 2 numeral 13 defines the manufacturer as the person responsible for design, manufacture, packaging and labeling who commercializes the device under its own name, and numeral 14 anchors intended use in what that manufacturer indicates. Together they fix the party and the scope before any classification question is asked, which is why the definition determination document should name the responsible entity and quote the intended use verbatim from the labeling — two lines of work that prevent the most common downstream inconsistencies.

4. Practical recommendations

1. Produce a definition determination document first: tick off the constituent elements of Article 2 numeral 1 or numeral 2 item by item, forming a one-page written conclusion, before entering the classification stage.
2. State the duration of continuous use in the technical description, mapped against the three thresholds of Article 2 numerals 3 to 5.
3. Unify the intended use statement across all three places: the registration dossier, the Spanish-language labels and instructions for use, and the promotional material must be consistent; a master record of intended use is the practical way to keep them aligned.
4. Prepare SaMD as a device, not as a software copyright matter: since the definition already covers software, lifecycle and risk management evidence should be organized to device requirements.

5. Verification checklist

• □ Confirmed under Article 2 numeral 1 that the product constitutes a medical device (including software cases)
• □ Confirmed under Article 2 numeral 2 the IVD character and the list of uses
• □ Stated the duration of continuous use, mapped against the 60 minutes / 30 days thresholds
• □ Confirmed the implantable character and the 30 days retention floor
• □ Verified consistency of intended use across the registration dossier, labels and instructions, and promotional material

Regulatory information verified as of October 29, 2026.

For a Chile market-entry feasibility assessment covering your specific product, contact the GRZAN regulatory team. GRZAN provides ISP registration and compliance support for the Chilean market: definition and classification determinations, threshold mapping against Article 2 of DS 825/1998, intended-use harmonization, and SaMD evidence packages. Reach us at info@grzanglobal.com.