Ecuador Medical Device Changes and Re-registration: Articles 28 and 42 Compared

1. Key takeaways

The new regulation draws the line between a change and a re-registration with two articles. Article 28 lists five situations that require a new registration certificate; Article 42 lists eight situations in which no re-registration is needed and the change procedure applies instead. The dividing question in both articles is whether the change alters the risk class of the device.

The five cases in Article 28: (a) a model change that significantly alters the design, function or operating principle and alters the risk class; (b) a change of intended purpose, where the medical purpose changes and the risk class changes; (c) a change of conditions of use, where the manner in which the device is applied changes; (d) a change in the chemical composition of the raw materials or in the energy source that alters the risk class; (e) a qualitative or quantitative change of formula for devices that have a formulation.

The eight cases in Article 42: (a) a change of trade name; (b) a change of product owner, certificate holder, manufacturer or primary manufacturer; (c) a change of name or business name of those parties or of the conditioning establishment; (d) a change of the relevant addresses; (e) a model change that does not affect the risk class, the intended purpose or the approved characteristics; (f) a change in the chemical composition of the raw materials that does not affect the risk class; (g) a change in the nature of the container or packaging material that does not alter the sterile condition; (h) a change, addition or removal of the commercial presentation.

2. Legal basis

3. Expert insights

Insight one: whether the risk class changes is the common test in both articles. Article 28 (a), (b) and (d) each carry the qualifier that the risk class changes; Article 42 (e) and (f) state expressly that the risk class is unaffected. The same type of event — a model change, a change of raw material — is routed to completely different procedures depending on that single question, which is why the assessment has to be documented rather than assumed.

Insight two: Article 28 (c) is the only case without the risk class qualifier. The text reads: a change of conditions of use where the manner in which the device is applied changes. In other words, if the mode of administration changes, a new registration is required whether or not the risk class moves. This is the easiest article to trip over, because the change may look clinically minor.

Insight three: the qualifier in Article 42 (g) is the sterile condition. A change in the nature of the container or packaging material goes through the change procedure only if it does not alter the sterility of the product. The reverse inference is that a packaging change which affects the sterile condition requires re-registration.

Insight four: Article 28 also fixes when the old certificate dies. Where a new certificate is obtained under these cases, the original certificate is cancelled within 90 days after the new certificate is issued. The exception is an authorised stock depletion (agotamiento de existencias), in which case cancellation takes place after that authorisation period expires. The 90 days are a deadline for the administrative step, not a licence to keep shipping.

Insight five: Articles 44 and 45 impose different prohibitions on domestic and imported devices.

• Article 44 (domestic devices): the holder may not manufacture or commercialise a device that incorporates an Article 42 change unless the change has obtained prior ARCSA approval;
• Article 45 (imported devices): the holder may not import or commercialise a device that incorporates an Article 42 change where that change affects the label and/or the instructions for use unless prior ARCSA approval has been obtained.

The difference is that the import prohibition is confined to changes affecting the label and/or the instructions for use, while the domestic prohibition covers any Article 42 change.

Insight six: the change procedure allows a single correction round. Article 43, item 4 provides that a file that fails review is returned for correction within 5 days and only once; if the deadline passes or the correction is inadequate, the status is recorded as not approved and the file is definitively cancelled. There is no second chance, so completeness at first filing is the whole game.

4. Practical recommendations

1. Make the first step of any change assessment a documented determination of whether the risk class is affected, and route the file to Article 28 or Article 42 accordingly.
2. Treat every change in the manner of administration as a new registration under Article 28 (c), not as a change notification.
3. Assess packaging material changes against the sterile condition before choosing the procedure.
4. Schedule the cancellation of the old certificate at 90 days after issuance of the new one, and arrange a stock depletion authorisation where inventory needs to move.
5. For imported devices, do not import a label or instructions change before approval under Article 45, and fix the switch-over date in advance.

5. Verification checklist

• □ A determination on whether the risk class is affected has been completed
• □ The Article 28 (c) administration-change scenario has been ruled out
• □ A packaging material change has been assessed for its effect on the sterile condition
• □ The cancellation date of the old certificate (90 days after the new one) has been scheduled
• □ A label change for an imported device has been scheduled for import only after approval
• □ A completeness self-check has been completed before filing (5-day correction, once only)

Regulatory information verified as of October 29, 2026

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• Local regulatory teams: target-market work is performed by locally licensed regulatory professionals, and submission dossiers are written directly in the local official language without secondary translation.
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Contact

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