Ecuador Medical Device Clinical Evidence Requirements: Biofunctional Studies and SaMD Clinical Evaluation

1. Key takeaways

The clinical evidence requirements of the new Ecuadorian regulation are concentrated in items 2.2 and 2.3 of Article 24. Biofunctional studies apply to class III and IV implantable invasive devices. Clinical studies or a SaMD clinical evaluation apply to class III and IV invasive devices (DMI), active devices (DMA) and in vitro diagnostics (DMDIV). Non-invasive devices (DMNI) are outside the mandatory scope.

The practical estimate used by GRZAN is that Ecuador is a jurisdiction where international clinical evidence, properly organised and cited, carries the file: the regulation points to recognised international sources and imposes no local study duty. The workload therefore shifts from generating new data to organising existing evidence into a verifiable package, which is a planning task rather than a research task — provided the type code and risk class are confirmed first.

2. Legal basis

Article 22 subparagraph (e) classifies software marketed as a medical device in its own right under the IMDRF/N12 risk matrix, which connects directly to the clinical evaluation duty of item 2.3. Article 65 on Type 2 post-market control provides the enforcement backdrop: registered products may be subject to laboratory re-testing, which is why underlying study data must be preserved.

3. Expert insights

Insight one: the mandatory clinical threshold is class III and IV, with non-invasive devices excluded. Item 2.3 lists its applicable types as DMI, DMA and DMDIV and does not include DMNI. This means that a non-invasive device, even when classified as class III or IV, does not fall within the mandatory clinical scope of item 2.3.

Insight two: SaMD is expressly brought within clinical evaluation. The text refers to clinical studies, or a SaMD clinical evaluation of the medical technology of the device. Combined with the IMDRF/N12 classification rule of Article 22 subparagraph (e), a SaMD that falls into class III or IV after classification must be supported by a clinical evaluation.

Insight three: the biofunctional studies of item 2.2 are separate from clinical studies. Their content is biofunctional studies based on scientific evidence, together with functional performance testing demonstrating that the device achieves its clinical purpose safely and effectively, limited to class III and IV implantable DMI. An implant can therefore trigger items 2.2 and 2.3 simultaneously.

Insight four: Article 20 opens a channel for the sources of evidence. The normative documents include WHO guidelines or technical reports, GHTF and IMDRF documents, ARCSA instructions, and official documents issued by other international reference regulatory authorities. Clinical study material completed with the FDA, the EMA and comparable agencies can therefore be cited as supporting evidence under this provision.

Insight five: the regulation does not mandate local clinical data. Nowhere does the new regulation require clinical trials to be conducted inside Ecuador. This contradicts secondary sources claiming that class III devices must submit a statement of clinical applicability from Ecuador — no such requirement appears in the text of Article 24.

The practical consequence of insight five deserves emphasis. Companies accustomed to markets that demand local data, or local clinical applicability statements, sometimes budget for an Ecuador-specific clinical work package that the regulation never asks for. The correct reading of Article 24 is narrower: the mandatory items are the biofunctional studies of item 2.2 for implantable DMI and the clinical studies or SaMD clinical evaluation of item 2.3 for the listed types in classes III and IV. Everything beyond those items is optional strengthening of the file — permitted under the same logic that lets applicants submit additional information proactively — but it is not a condition of approval, and treating it as one distorts both budget and timeline.

4. Practical recommendations

1. Apply the dual test of type and class: first confirm whether the product is DMI, DMA or DMDIV, then check whether it is class III or IV.
2. Prepare implants under both items: class III and IV implantable devices may trigger the biofunctional studies of item 2.2 and the clinical studies of item 2.3 at the same time.
3. Organise existing international evidence under Article 20: compile it into a verifiable package of official documents with sources and versions attached.
4. Do not over-prepare clinical data for non-invasive products: the regulation places them outside the mandatory scope.
5. Retain the original study data and statistical records: they must be available for the laboratory re-testing that Article 65 provides under Type 2 post-market control.

5. Verification checklist

A final organisational note concerns the citability of the evidence package. Article 20 makes official documents from international reference regulators usable, but usability in the regulatory sense means the reviewer can locate and confirm each source: full title, issuing body, document version and date. A clinical evaluation that cites a guideline by name only, without version and source, forces the reviewer to search, and searching is what generates questions. The same discipline applies to the raw data retained for Type 2 post-market control under Article 65 — archived data that cannot be retrieved coherently provide no protection during laboratory re-testing.

• □ The type code and risk class of the product have been confirmed.
• □ It has been determined whether the product falls within item 2.3 as DMI, DMA or DMDIV in class III or IV.
• □ The concurrent application of item 2.2 has been assessed for implantable products.
• □ SaMD has been classified under IMDRF/N12 and assessed by class.
• □ International clinical evidence has been organised into a citable package under Article 20.
• □ Original study data and statistical records have been archived.

Regulatory information verified as of October 29, 2026

GRZAN supports manufacturers, importers and authorised representatives building clinical evidence packages for Ecuador medical device registration, from Article 24 applicability screening and SaMD classification to the organisation of international evidence under Article 20. For tailored assistance with your Ecuador medical device registration, contact us at info@grzanglobal.com.