Ecuador Final Label Submission: Article 27 and Notification Code NDM017

1. Key takeaways

Article 27 requires the holder to submit to ARCSA, within no more than one year of obtaining the registration certificate and before the device is commercialised, the final label bearing the granted registration number. Failure to do so is sanctioned under the Organic Health Law and other applicable rules.

The vehicle for that submission is a registration certificate notification (notificación), filed under Resolucion ARCSA-DE-2023-005-AKRG, and the corresponding notification code is NDM017. The code was not created by the body of the new regulation: it was inserted into the notification table of the 2023 resolution by the seventh amending provision (SEPTIMA) of Resolucion ARCSA-DE-2026-003-DASP.

Read together, the obligation and the notification route form a single chain: Article 27 states the duty, the seventh amending provision supplies the code, and the 2023 resolution supplies the procedure. Quoting NDM017 without that chain is a common source of filing errors.

2. Legal basis

Substance of the seventh amending provision: in the table in Article 4 of Resolucion No. ARCSA-DE-2023-005-AKRG, concerning Chapter III of the guide on notifications for medical device registration certificates, a new code NDM017 is inserted after NDM016, described as the submission of the final label after the certificate is granted, and its submission following an update that affects the approved final label.

3. Expert insights

Insight one: Article 27 sets two time conditions that must both be met. The submission must fall within one year of the certificate and before commercialisation. In practice the earlier of the two governs: a product planned for launch six months after approval must have its final label filed before that sixth month. The one-year limit is a ceiling, not a buffer.

Insight two: NDM017 rests on an amending provision, not on a body article. The new regulation writes the code into the notification catalogue of Article 4 of Resolucion 2023-005-AKRG through amending provision seven. The correct citation chain is therefore Article 27 for the obligation, amending provision seven for the code, and Resolucion 2023-005-AKRG for the notification procedure itself.

Insight three: Article 27 covers the first submission and later updates. The wording of the article and the description of NDM017 corroborate each other: the duty applies not only to the submission made after approval, but also to an update that affects the approved final label. Every label revision is therefore a potential new notification event, including revisions that look purely editorial.

Insight four: Article 27 states the legal consequence in the article itself. The text provides that a breach is sanctioned under the Organic Health Law and other applicable rules. That phrasing lifts the final label out of the technical checklist and into enforceable law, with the sanction route in Article 72 behind it.

Insight five: the provision pairs with Article 24, item 1.2. What is filed with the application is a draft label (proyecto de etiquetas); what is filed after approval is the final label (etiquetas definitivas). The substantive difference is that the final label must carry the granted registration number, which is a label element required by Article 49, item (l).

Insight six: Articles 54 to 57 provide a buffer for existing label stock. Where a label or set of instructions for use has to change, the holder may apply for a stock depletion authorisation (agotamiento de existencias), which ARCSA analyses and may grant for a limited period during which existing inventory can be sold. Article 57 governs the depletion period that ARCSA grants.

4. Practical recommendations

1. Put the final label submission into the compliance calendar against the planned launch date, not against the one-year anniversary of approval.
2. Run packaging finalisation and final label filing in parallel, so that an unfinalised carton does not delay the notification.
3. Build a trigger review for every label revision, deciding each time whether an NDM017 update is required.
4. Assess a stock depletion authorisation under Articles 54 to 57 whenever labels change, to avoid scrapping saleable inventory.
5. Check the 13 elements of Article 49 before the final label is printed, with particular attention to the registration number.

5. Verification checklist

• □ The final label submission is in the compliance calendar, dated before the planned launch
• □ The final label carries the registration number (Article 49, item l)
• □ The NDM017 notification channel and filing method have been confirmed
• □ A trigger review mechanism for label revisions has been established
• □ A stock depletion authorisation has been assessed for label changes (Articles 54 to 57)
• □ The final label has been checked against the 13 elements of Article 49

Regulatory information verified as of October 29, 2026

GRZAN core service lines

1. Global registration access: EU CE (MDR/IVDR), US FDA (510(k)/De Novo/PMA), UK UKCA, Australia TGA, Canada Health Canada, Brazil ANVISA and Russia RZN, together with pre-market registration pathway planning and submission execution across Latin America, Southeast Asia and the Middle East.
2. Authorized representative services: EU EC REP, UK RP, Swiss CH REP, Australian sponsor and US Agent holding and representation services, with support for neutral license-holder structures.
3. Quality system compliance: ISO 13485 establishment and maintenance, MDSAP audit preparation, GMP conformity coaching, and technical documentation (TD) drafting and remediation.
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5. Post-market compliance: vigilance and adverse event reporting, FSCA and recall execution, registration change and renewal management, and maintenance of national regulatory databases.

Why manufacturers choose GRZAN

• 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.
• Neutral license-holder structures: GRZAN offers holding arrangements that are not tied to any distribution channel, preventing registration certificates from being locked in by channel partners.
• Regional leverage: one technical dossier can be reused across Andean Community and Mercosur member states, spreading regional compliance costs.
• Full lifecycle support: from classification determination and pathway design through dossier preparation, license holding, customs clearance, post-market vigilance and renewal.

Contact

• GRZAN provides registration support in Ecuador for manufacturers, importers and authorized representatives.
• Email: info@grzanglobal.com
• Service inquiries: Ecuador and Andean market registration plans, license-holder structure design, official fee and timeline estimation