Ecuador Medical Device Stability, Sterility and Biocompatibility Studies: Trigger Conditions under Article 24

1. Key takeaways

Three technical reports that are routinely prepared as one bundle in other markets have distinct trigger conditions under the new Ecuadorian regulation. Stability studies apply only to devices whose characteristics or intended use require a labelled expiry date. Sterility certificates apply only to sterile devices or to components intended for sterile products. Biocompatibility studies based on ISO 10993 apply only to class III and IV invasive devices (DMI).

The practical estimate used by GRZAN is that a disciplined three-question screen — does the product carry an expiry date, is it sterile, and is it a class III or IV DMI — resolves the applicability of the entire bundle in minutes. Teams that skip this screen and copy a European-style study package pay for studies the regulation never asked for, while occasionally missing the quality assurance certificate of item 1.9 C, which is the one truly universal item in this group.

2. Legal basis

Class-by-class applicability rules:

• Stability studies: DMI and DMNI in all classes; therapeutic DMA and the DMDIV described as non-electronic medical equipment or laboratory equipment in all classes.
• Sterility certificates: DMI and DMNI in all classes; only therapeutic DMA in all classes.
• Biocompatibility: only class III and IV DMI.
• Biofunctional studies: only class III and IV implantable DMI.

3. Expert insights

A short reading note helps to interpret the applicability list above. The regulation does not ask whether a study would be nice to have; it asks whether the combination of type code and risk class falls inside the row. Therapeutic DMA appears in both the stability and the sterility rows, which means electrical therapeutic equipment carrying an expiry date must present both reports. Non-therapeutic DMA — for example purely diagnostic electronic equipment — appears in neither row unless the product is sterile. Reading the rows in this way turns the matrix into a mechanical screening exercise that two people can complete independently and reconcile in under an hour.

Insight one: the trigger for stability studies is the labelled expiry date, not the risk class. The text limits the requirement to devices that, because of their characteristics or their use, need a labelled expiry date. A product that carries no expiry date does not trigger this item even if it belongs to a high risk class.

Insight two: the trigger for the sterility certificate is sterility itself, independent of the class. The text applies the item only to sterile devices or to components intended for sterile products. The deciding factor is the sterile status of the product, not its risk classification.

Insight three: biocompatibility is confined to the two highest classes of invasive devices, which differs from the practice of most markets. Under the EU MDR, biological safety evaluation is a universal requirement, whereas Ecuador confines item 2.1 to class III and IV DMI. This is a genuine cost-optimisation opportunity for Chinese manufacturers, but only after the type code has been confirmed — if the product is classified as DMI, classes III and IV must submit the studies.

Insight four: the quality assurance certificate of item 1.9 C is mandatory for all classes. A quality assurance certificate or conformity certificate issued by the manufacturer, drawn up in accordance with the instructions published by ARCSA, applies to all devices in all risk classes. This is the catch-all item of the finished product control group.

The catch-all character of item 1.9 C deserves a moment of attention. Because it applies to every device in every class, it is the only document in this group that appears in every Ecuadorian project regardless of product profile. It also carries a formatting dependency: the certificate must follow the instructions published by ARCSA, which means the issuing factory cannot simply reuse the certificate layout it sends to other Latin American markets. Project plans should therefore include a step that compares the draft certificate against the current ARCSA instructions before signature, since a non-conformant format discovered during the review costs a correction cycle that the 5-day completeness window cannot absorb.

Insight five: items 1.6 and 1.7 form the upstream support of the finished product control. The description of raw materials or materials (item 1.6) and the description of the primary and secondary containers with their technical specifications (item 1.7) provide the argumentative foundation on which the stability and sterility conclusions rest. The dossier should close the loop by cross-referencing these items.

4. Practical recommendations

1. Determine the trigger conditions before deciding on investment: screen every product against the three questions — is an expiry date labelled, is the product sterile, and is it a class III or IV DMI.
2. Confirm the type code before concluding: the applicability of biocompatibility depends entirely on the DMI classification, so boundary products should be pre-confirmed with ARCSA.
3. Check stability studies against the tiered rule of item 1.9 A: therapeutic DMA and non-electronic equipment DMDIV are covered; the remaining DMA and equipment-type DMDIV are not.
4. Close the argumentative loop across the three reports: cross-reference them with the raw material and container descriptions of items 1.6 and 1.7.
5. Issue the quality assurance certificate according to the ARCSA instructions: track the publication of the instructions and do not rely on self-made templates.

5. Verification checklist

Two cross-article notes complete the picture. First, the same stability and sterility conclusions feed other parts of the dossier: the expiry date and storage conditions declared on the label under Article 49 must be the same values that the stability study supports, and the sterile claim must match the sterility certificate. Second, the correction economics amplify the value of getting the screen right the first time — the completeness review allows only one correction round of 5 days under Article 26 item 4, so a missing report discovered at that stage leaves almost no room for recovery.

• □ It has been determined whether the product requires a labelled expiry date, which decides the stability study.
• □ It has been determined whether the product is a sterile device, which decides the sterility certificate.
• □ It has been confirmed whether the product is a class III or IV DMI, which decides biocompatibility.
• □ The quality assurance certificate has been issued in the format indicated by ARCSA.
• □ The raw material and container descriptions have been prepared in parallel.
• □ The three reports and the upstream data are cross-referenced.

Regulatory information verified as of October 29, 2026

GRZAN supports manufacturers, importers and authorised representatives scoping stability, sterility and biocompatibility documentation for Ecuador medical device registration, from trigger-condition screening and ISO 10993 gap analysis to ARCSA-conformant quality assurance certificates. For tailored assistance with your Ecuador medical device registration, contact us at info@grzanglobal.com.