Ecuador Medical Device Observaciones Process: Correction Windows, Refunds and Re-application Rules

1. Key takeaways

The observaciones — correction — rules are the most operationally valuable design of the Ecuadorian revision. At the completeness review stage: the file is returned for correction with a deadline of 5 days, once only; missing the deadline cancels the application automatically. At the technical evaluation stage: the ordinary procedure grants two rounds of corrections of 30 days each for domestically manufactured products and 60 days for foreign-manufactured products; the simplified procedure likewise grants two rounds of 60 days each. Where an application is cancelled after failed corrections, the fees already paid are not refunded, and a new application requires new fees.

The practical estimate used by GRZAN is that the 5-day completeness window, not the technical evaluation, is where Ecuadorian projects are won or lost: five days is enough only for a correction package that has been pre-built and pre-authorised. Everything an applicant can do before submission — matrix self-checks, consistency reviews, signature delegations — converts pressure away from that window and into calmer months of the project.

2. Legal basis

Two further provisions complete the picture. Article 26 items 6 and Article 35 item 5 place the payment after the review: the system notifies the amount once the review is passed and the applicant has 10 legal terms to pay before automatic cancellation. Article 11 fixes the contents of the application at the moment of submission: entries may not be added or changed afterwards, which is the one-time-finalisation principle.

3. Expert insights

Insight one: the 5-day window at the completeness review is extremely short and offers a single opportunity. Article 26 item 4 and Article 35 item 4 are aligned: the file is returned to the applicant with a deadline of 5 days, once only. This is the step of the whole process that demands the fastest cross-border response — without a pre-built response mechanism, a Chinese manufacturer and its local licence holder will find it nearly impossible to complete the correction within 5 days.

Insight two: the correction windows at the technical evaluation stage are wider for foreign-manufactured products. Article 26 items 10 and 11 grant 30 days for domestic manufacture and 60 days for foreign manufacture, in two rounds. This is a deliberate institutional concession to the realities of cross-border supply chains, and Chinese companies should make full use of it.

Insight three: the cost of failed corrections is a double loss of fees and time. Article 18 provides that where an application is cancelled for improper or late correction, the fees already paid are not refunded; Article 26 items 10 and 11 add that restarting the procedure requires the corresponding fees to be paid again. Article 35 items 8 and 9 are stricter for the simplified procedure: where the correction is not filed within the deadline, the procedure is cancelled with final effect and a new application must be filed.

Insight four: Article 10 offers a suspension, not a rejection, for entries above the ceiling. Applications exceeding the limits of 100 entries for devices or 50 for in vitro diagnostics are not evaluated until the applicant corrects them. This gives over-limit applications a chance to be fixed, but the clock keeps running.

Insight five: payment falls after the review, which is a favourable cash flow arrangement. Article 26 item 6 and Article 35 item 5 are aligned: after the review is passed the system notifies the amount, and the applicant has 10 legal terms to pay, with automatic cancellation thereafter. No payment is due at submission, so the sunk cost of a failed project is limited — but the no-refund rule of Article 18 covers the failed-correction scenario.

Insight six: the one-time-finalisation principle of Article 11 requires the entry list to be locked before submission. No entries may be added or modified after the application is filed. The model list, the trade names and the manufacturer information must therefore pass a three-level internal review before the file leaves the building.

4. Practical recommendations

1. Run a dossier completeness self-check against the Article 24 matrix: move the pressure of the 5-day window forward into a pre-submission inspection.
2. Pre-build the correction response mechanism with the licence holder: including signed delegations, document templates and a named local submission owner.
3. Use the full 60-day window for foreign-manufactured products: but never treat it as slack — once the two rounds are exhausted, the cancellation is final.
4. Set the cash flow control point at failed corrections: quantify the repeat-payment sunk cost under Article 18 before submission.
5. Complete the three-level entry review before submission: trade name, model and manufacturer must match the CLV and the power of attorney exactly.

5. Verification checklist

• □ A dossier completeness self-check has been completed against the Article 24 matrix.
• □ A signed delegation and response mechanism for 5-day corrections has been agreed with the licence holder.
• □ The number of entries has been confirmed as within the limits, 100 for devices and 50 for DMDIV.
• □ Trade name, model and manufacturer information are identical across all documents.
• □ The repeat-payment cost of failed corrections has been quantified under Article 18.
• □ A payment window of 10 legal terms has been reserved in the project plan.

Regulatory information verified as of October 29, 2026

GRZAN supports manufacturers, importers and authorised representatives navigating the Ecuadorian observaciones process, from pre-submission completeness audits and 5-day response mechanisms to fee exposure planning under Article 18. For tailored assistance with your Ecuador medical device registration, contact us at info@grzanglobal.com.