Ecuador Active Medical Device Requirements: Nuclear Application Authorisation and IEC Conformity Certificates

1. Key takeaways

Active devices (DMA) carry two dedicated requirements under Article 24 of the Ecuadorian regulation. Item 2.6: for DMA using controlled energy with ionising radiation, an authorisation or licence issued in the name of the applicant by the competent authority for nuclear application control must be submitted, applicable to all risk classes. Item 2.7: DMA and DMDIV regarded as electronic medical equipment or laboratory equipment, together with devices that require energy to operate, must submit the applicable IEC conformity certificate, likewise for all risk classes.

The practical estimate used by GRZAN is that for radiation-emitting products the nuclear application authorisation is the critical-path document of the whole Ecuadorian project, because it cannot be obtained by the foreign manufacturer in its own name and must instead be secured through the local applicant before submission. For all other active products, the IEC certificate is a planning task that can run in parallel with dossier assembly, provided the applicable standard numbers are fixed early.

2. Legal basis

Article 21 subparagraph (a) defines the active device category, while Article 3 supplies the definitional infrastructure on which both items rest: the abbreviation list includes the IEC, the International Electrotechnical Commission, and IA, Inteligencia Artificial, artificial intelligence. These definitions anchor the scope of the conformity certificates and anticipate future technology-specific requirements.

3. Expert insights

Insight one: the authorisation of item 2.6 is issued in the name of the applicant, not of the foreign manufacturer. The text requires an authorisation or licence issued in the name of the applicant. This means the authorisation must be obtained by the Ecuadorian local applicant or licence holder, and a Chinese manufacturer cannot secure it in its own name — of the two dedicated requirements this is the only one with a territorial character, and it must be planned in advance.

Insight two: item 2.6 covers DMA using controlled energy with ionising radiation, not every device containing radiation. The text limits the requirement to controlled-energy DMA that uses ionising radiation. Diagnostic X-ray equipment and radiotherapy units are the typical subjects; ordinary active devices without ionising radiation are outside the scope.

Insight three: the IEC certificate of item 2.7 reaches wider than intuition suggests. The text applies it to DMA and DMDIV regarded as electronic medical equipment or laboratory equipment, in all risk classes, and additionally to devices that require energy in order to operate. The second phrase extends the scope from electronic medical equipment to every device that depends on an energy source to run.

Insight four: both requirements are mandatory for all classes, without class-based exemptions. Unlike class-tiered items such as biocompatibility, items 2.6 and 2.7 treat classes I to IV identically. The document list for active devices is therefore comparatively fixed and predictable.

That predictability is worth using deliberately. Because the two items do not vary with class, the difference between a class II monitoring device and a class IV radiotherapy unit, from a documentation standpoint, lies almost entirely in whether item 2.6 attaches — not in how item 2.7 is satisfied. Project teams can therefore maintain a standing active-device document template for Ecuador: IEC conformity certificates covering every declared model, energy-dependence analysis for item 2.7, and — where ionising radiation is present — the applicant-named authorisation tracked on the critical path. The only variable part is keeping the certificate list synchronised with the model list locked in at submission under Article 11, since an IEC certificate that misses a late-added model cannot be patched after filing.

Insight five: Article 3 already embeds IEC and artificial intelligence into the definitional system. The abbreviation list includes the IEC, the International Electrotechnical Commission, and IA, artificial intelligence. This lays the conceptual groundwork for future AI and machine learning requirements, but the text of the new regulation does not yet establish a dedicated data item for algorithm transparency or training data.

4. Practical recommendations

1. Treat the nuclear application control authorisation as a project critical path for radiation equipment: because it must be obtained in the name of the applicant, it has to be completed before submission.
2. Arrange IEC certificates for active products early: identify the applicable IEC standard numbers and confirm that the certificate covers the declared models.
3. Self-check item 2.7 against the question of whether the device needs energy to operate: do not read the scope narrowly as electronic medical equipment only.
4. Manage the validity of both certificates across the review window: bring them onto the same validity dashboard as the CLV and the system certificate.
5. File AI and machine learning products under the existing framework, while tracking whether ARCSA issues dedicated instructions on algorithm transparency and training data.

5. Verification checklist

A closing note on sequencing. The nuclear application authorisation and the IEC certificate have different clock characteristics: the former depends on an Ecuadorian authority acting in the applicant’s name and should be started as soon as the local applicant is engaged, while the latter depends on a testing or certification body abroad and can be ordered in parallel with dossier assembly. Treating them as one undifferentiated certificate task is the most common scheduling error in active-device projects; splitting them into two workstreams with separate owners keeps the submission date independent of the slower of the two.

• □ It has been determined whether the product is a controlled-energy DMA using ionising radiation.
• □ The nuclear application control authorisation has been obtained in the name of the applicant or licence holder.
• □ The applicable IEC standard numbers have been identified and the conformity certificate obtained.
• □ The IEC certificate covers every model declared in this application.
• □ The validity of both certificates covers the review window.
• □ The applicability of item 2.7 has been re-checked against the question of whether the device depends on energy to operate.

Regulatory information verified as of October 29, 2026

GRZAN supports manufacturers, importers and authorised representatives handling the dedicated requirements for active devices in Ecuador, from nuclear application control authorisations secured through the local applicant to IEC conformity certificates scoped against items 2.6 and 2.7. For tailored assistance with your Ecuador medical device registration, contact us at info@grzanglobal.com.