IVD Classification from Class A to D in Chile

1. Key takeaways

Chile applies a four-tier classification of Classes A, B, C and D to in vitro diagnostic medical devices (DMDIV/IVD), running in parallel with Classes I, II, III and IV for devices and following the internationally common IVD risk classification model. The selection logic of the Decreto Exento N° 25, de 2026 states expressly: Class C and D IVDs are prioritized (with some Class B assays also included).

The GRZAN judgment: the first move for an IVD manufacturer in Chile is not preparing the dossier, but establishing which of the A to D tiers the product occupies — the tier determines whether the product is already included, which transition-period band it falls into, and how deep the analytical performance evidence must go.

The parallel structure deserves emphasis because it is easy to misread. Devices and IVDs are regulated under the same statutory umbrella — Article 111 of the Sanitary Code and DS 825/1998 — but they carry different classification vocabularies and different evidence traditions. A company that handles both product types must therefore maintain two classification determinations, two evidence templates and two labeling reviews, unified only at the level of the submission itself. Treating the IVD line as a footnote to the device line is a common organizational error that surfaces late, usually at the moment the analytical performance modules are requested.

2. Legal basis

• Decree including listed devices in the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | March 19, 2026 | the included IVDs include Helicobacter pylori assays, HPV assays, respiratory virus assays (including influenza, SARS-CoV-2 and others), blood glucose monitoring systems, pregnancy tests and others; the selection criteria expressly prioritize Class C and D IVDs.
• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 2 numeral 2: definition of IVD (reagents, calibrators, control materials, equipment, instruments, apparatus or systems).
• Same source | Article 20: four-class risk classification for devices (applied in parallel with the A to D classification for IVDs).
• Inclusion decree for HIV in vitro diagnostic reagents | Decreto Exento N° 41, de 2022 | 2022 | confirms that conformity verification is conducted through document review.

3. Expert insights

Insight 1: two classification systems run in parallel, but the transition period follows only the product list.

A to D and I to IV are two naming systems that do not need to be forcibly converted in practice; what actually drives scheduling is the transition-period band of the product in the list of the Decreto Exento N° 25, de 2026. The Decreto Exento N° 41, de 2022 (HIV assays) belongs to the pre-existing controlled categories and sits outside the transition arrangements of the 2026 decree, so its holders manage obligations under the existing regime rather than the new countdown.

Insight 2: the priority given to Classes C and D shows regulatory resources are aimed at assays whose results directly trigger clinical decisions.

Helicobacter pylori, HPV, respiratory viruses, blood glucose monitoring and pregnancy testing share one defining characteristic: the test result directly triggers treatment or a public health intervention. From this GRZAN infers that tumor markers, infectious disease serology, and blood grouping and matching assays of the same character are high-probability candidates for the next batch of expansion, and manufacturers of such assays should read their own portfolios as a forecast of the list.

Insight 3: IVD verification is document-review based, and analytical performance evidence is the core.

The path of verification through document review established by the Decreto Exento N° 41, de 2022 continues under the framework of the Decreto Exento N° 25, de 2026. This means the center of gravity of an IVD submission lies not in sample testing but in the written evidence chain for analytical and clinical performance: limit of detection, precision, interference, stability, and agreement with reference methods, each documented and internally consistent.

Insight 4: IVDs are typically submitted as a system.

Blood glucose monitoring is expressed as a system, comprising the meter, the test strips, the lancets and the control solutions. GRZAN recommends fixing the system boundary and the accessory list before submission, so that later additions of accessories do not trigger change notifications; retrofitting an accessory into a registered system costs far more than declaring it at the outset.

The system logic extends to how the evidence should be organized as well. Because the decree defines IVDs as reagents, calibrators, control materials, equipment, instruments, apparatus or systems, the submission must show that the declared configuration works as a whole — which in practice means the analytical performance modules are run with the consumables and controls that will actually be sold. A dossier assembled from fragments tested with mismatched lots invites technical questioning, and under a document-review regime the written record is the only thing the reviewer sees.

4. Practical recommendations

1. Fix the tier before touching the dossier: determine the A to D tier of the product, then check the list of the Decreto Exento N° 25, de 2026 to confirm whether it is already included.
2. Define the submission unit as a system: write the boundaries of the instrument, reagents, consumables and controls clearly, and submit the complete configuration in one application.
3. Organize analytical performance evidence in modules: limit of detection, precision, interference and cross-reactivity, stability, and method comparison, each written up as its own module.
4. Watch the public health emergency provisions: the competent authority may impose additional clinical and analytical performance requirements on IVDs during a public health emergency, so the evidence package should leave room to extend.

5. Verification checklist

• □ Determined the A to D tier of the IVD product with written records
• □ Confirmed whether the product is within the list of the Decreto Exento N° 25, de 2026 and its corresponding transition period
• □ Defined the system submission boundary and the accessory list
• □ Organized analytical performance evidence in modules (limit of detection, precision, interference, stability, method comparison)
• □ Confirmed that the Spanish-language labels and instructions for use match the submission

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: IVD tier determinations, system-boundary definition, modular analytical performance evidence packages, and Spanish-language labeling reviews. Reach us at info@grzanglobal.com.