Ecuador Medical Device Technical Dossier: The Article 24 Type and Risk-Class Matrix

1. Key takeaways

Article 24 is the core provision of the Ecuadorian technical dossier. It applies its requirements through a two-dimensional matrix of device type multiplied by risk class. Four items are mandatory for every type and every class: the description and interpretation of the batch number or serial number, the label draft, the instructions for use or user manual, and the manufacturing process information including a flow chart. Biocompatibility studies apply only to class III and IV invasive devices (DMI) — the requirement most likely to be overestimated by companies preparing for this revision.

The practical estimate used by GRZAN is that a project team that first fixes the type code and the risk class, and only then reads the matrix row by row, will assemble a materially leaner dossier than one that copies a generic checklist. Over-preparing studies that the matrix does not require wastes budget, while missing one of the four all-class items guarantees a correction request during the completeness review.

2. Legal basis

Structure of Article 24: the first major group covers the requirements that demonstrate the quality of the finished product (items 1.1 to 1.9); the second major group covers the requirements that demonstrate the safety and efficacy of the finished product, as applicable (items 2.1 to 2.7). Article 21 defines the type codes DMA, DMI, DMNI and DMDIV and the risk classes I to IV; Article 12 requires the technical file in Spanish or English with a list electronically signed by the Ecuadorian technical responsible person.

3. Expert insights

Insight one: the matrix logic is dual — type and class — not class alone. The same data item may apply differently to invasive devices (DMI) and active devices (DMA). For example, the description of raw materials or materials applies to DMNI, DMI and DMDIV in all classes, but for DMA it applies only to therapeutic devices, in all classes. When assembling the dossier, the type code must be fixed first and the class consulted second; both steps are indispensable.

Insight two: the four all-class mandatory items form the skeleton of the package.

• Item 1.1, description and interpretation of the batch number or serial number — the text marks it as mandatory for all devices in all risk classes;
• Item 1.2, the label draft — it must be a PDF, not a photocopy, an image or a scan, and must state the information required by Article 49;
• Item 1.3, the instructions for use or user manual — it must be written in Spanish, and may additionally contain other languages;
• Item 1.8, manufacturing process information — it must include a flow chart of the production process.

Insight three: the biocompatibility requirement of Article 24 is much narrower than the industry expected. Item 2.1 provides that biocompatibility studies based on the ISO 10993 standards apply only to class III and IV DMI. This means that non-invasive devices, active devices and in vitro diagnostics do not trigger this mandatory requirement at all.

Insight four: the biofunctional studies of item 2.2 target implantable devices. The text requires biofunctional studies based on scientific evidence, together with functional performance testing demonstrating that the device achieves its clinical purpose safely and effectively, only for class III and IV implantable DMI. Implantability is the implicit qualifier of this item.

Insight five: item 2.3 brings software within the scope of clinical evaluation. The text refers to clinical studies, or a SaMD clinical evaluation of the medical technology of the device, applicable to class III and IV DMI, DMA and DMDIV. Note that non-invasive devices (DMNI) are outside the scope of this item.

Insight six: Article 24 reserves an offline channel for oversized files. Where the system cannot upload the material because of storage capacity, the documentation must be submitted by official letter (oficio) with a magnetic medium (CD) or other electronic means to the ARCSA zonal coordination office or headquarters, and the number of the oficio must be stated in the application submitted through the VUE system.

Insight seven: the applicant may proactively submit additional information. Where the applicant holds device-relevant information beyond the listed items, it may optionally include it in the registration application. This gives companies holding stronger evidence a route to a more robust file.

4. Practical recommendations

1. Fix the type code before consulting the class: work through the DMA, DMI, DMNI and DMDIV codes with classes I to IV cell by cell and derive the project-specific document list from the matrix.
2. Do not spend money on items the matrix does not trigger: non-implantable products do not need a full biocompatibility package prepared by habit.
3. Output the label draft strictly as a native PDF, never as a scan or an image, to avoid a formal correction.
4. The instructions for use must be in Spanish: an English-only manual is acceptable only in the additional-language position, never as the sole version.
5. Plan the oficio channel for oversized files early: confirm the receiving zonal coordination office and preserve the oficio number for entry into the VUE application.

5. Verification checklist

• □ The type code (DMA, DMI, DMNI or DMDIV) and risk class of every product have been determined.
• □ The applicable items have been ticked against the Article 24 matrix for this project.
• □ The four all-class mandatory items are complete.
• □ The label draft is a native PDF, not a scan or an image.
• □ The instructions for use have been written in Spanish.
• □ The manufacturing process information includes a flow chart.
• □ The oficio submission channel and the number back-entry method for oversized files have been confirmed.

Regulatory information verified as of October 29, 2026

GRZAN supports manufacturers, importers and authorised representatives assembling Ecuadorian technical dossiers under the Article 24 type and risk-class matrix, from matrix mapping and mandatory-item checks to oversized-file oficio handling. For tailored assistance with your Ecuador medical device registration, contact us at info@grzanglobal.com.