Ecuador Medical Device Registration Pathways 2026: General and Simplified Procedures under ARCSA

1. Key takeaways

Article 7 of the new regulation establishes two registration routes: general registration (inscripción general) and registration under the simplified procedure (inscripción por proceso simplificado). The two routes differ significantly in entry form, dossier intensity, number of correction rounds and assessment period. The ARCSA assessment period for the simplified procedure is 30 statutory periods (días término) under Article 33, but after approval the applicant must submit, through a variation application, all of the information required for general registration within 30 statutory periods; if that deadline is missed, the granted certificate is canceled immediately. The simplified route is therefore a fast entry with a deferred dossier obligation, not a lighter overall requirement.

2. Legal basis

3. Expert insights

Insight 1: the milestone differences between the two procedures can be compared cell by cell.

Insight 2: the simplified procedure means certificate first and dossier later, not a smaller dossier. Article 34 requires only 6 items of information to enter the simplified procedure, but its final paragraph provides that the remaining information required for general registration must be submitted through a variation application within 30 statutory periods after the registration is granted; if it is not submitted within that period, ARCSA will immediately cancel the issued certificate. Companies should treat the approval date as the start of a second, equally demanding documentation sprint rather than as the finish line of the project.

Insight 3: the technical assessment period of the general procedure is floating, and this common industry misreading must be corrected. Article 26(8) states in its original wording that the time taken by the ARCSA assessment depends on the risk class, the device type and the complexity of the procedure; the regulation sets no fixed number of days. The figure of a 60-day technical assessment for general registration in Ecuador that circulates online actually refers to the applicant correction windows in Article 26(10)–(11), not to an ARCSA review deadline. Planning the general route on the assumption of a fixed 60-day assessment is therefore structurally wrong and will distort project schedules.

Insight 4: the two 60-day correction rounds of the simplified procedure are a substantive advantage for importers. Under Article 35(8)–(9), where the technical assessment raises observations, the system generates a single consolidated correction report and allows the applicant a first correction of 60 days; if the correction is insufficient, ARCSA grants a second and final correction of the same 60 days. The two rounds together give up to 120 days of correction space, significantly more than the 30 days the general procedure grants for domestically manufactured products. For foreign-made devices, the 60-day per-round rhythm matches the realistic speed of cross-border document flows.

Insight 5: once a route is chosen it cannot be switched midway, and the cost of failure is a double loss of fees and time. Article 36 provides that if ARCSA discovers during the document review that the applicant has changed the simplified procedure application form into a general registration application form, it will finally cancel the simplified procedure application, record the status as not approved, and require the applicant to file again. Article 26(10)–(11) further makes clear that restarting the procedure after failed corrections requires payment of the applicable fees again. Route selection is therefore a one-way decision that deserves a formal internal review before filing.

Insight 6: payment comes after the review, which is a favorable cash-flow arrangement. Both procedures work the same way: after the review is passed, the system notifies the amount due and the applicant has 10 statutory periods to pay, with automatic cancellation if the deadline lapses. No payment is due at submission, but Article 18 provides that fees already paid are not refunded when an application is withdrawn after failed corrections. Budgeting should therefore be phased rather than front-loaded.

4. Practical recommendations

1. Choose the route by dossier readiness rather than by headline duration: for products for which the full dossier of Article 24 can be assembled at submission, the general procedure is the more stable option.
2. For the simplified procedure, prepare the information to be completed within 30 periods after approval before filing; do not wait until the certificate is issued to start that workstream.
3. Agree with the certificate holder on a 5-day correction response mechanism, covering document templates, signing authority and a designated filing owner.
4. Fix the route choice once: complete the internal route review before submission to avoid triggering the final cancellation of Article 36.
5. Arrange cash flow around post-review payment and reserve the 10-statutory-period payment window in the finance plan.

5. Verification checklist

• □ Confirmed that the product meets the eligibility conditions of the simplified procedure (see articles 12 and 14)
• □ Assembled the 6 items of simplified procedure information required by Article 34
• □ Prepared in parallel the full general registration dossier to be completed within 30 statutory periods after approval
• □ Agreed with the certificate holder on a 5-day correction response mechanism
• □ Completed the internal route selection review (avoiding mid-course switching)
• □ Phased cash flow around the 10-statutory-period post-review payment window

Regulatory information verified as of October 29, 2026

Core service areas

1. Global market access: EU CE (MDR/IVDR), US FDA (510(k)/De Novo/PMA), UK UKCA, Australia TGA, Canada Health Canada, Brazil ANVISA and Russia RZN, plus premarket registration pathway planning and filing execution across Latin America, Southeast Asia, the Middle East and other markets.
2. Authorized representative services: EU authorized representative (EC REP), UK responsible person (UK RP), Swiss authorized representative (CH REP), Australia sponsor and US Agent, together with neutral certificate-holder structure design.
3. Quality system compliance: ISO 13485 implementation and maintenance, MDSAP audit preparation, GMP conformity coaching, and technical documentation (TD) authoring and remediation.
4. Clinical and evaluation: clinical evaluation plans (CEP) and reports (CER), equivalence argumentation, PMCF planning and execution, and IVD performance evaluation.
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 GRZAN

• Local regulatory teams: filings in each target market are executed by locally licensed regulatory professionals and prepared directly in the official language of the market, without secondary translation.
• Neutral holding structure: certificate-holding arrangements that are not tied to any distribution channel, keeping registrations independent of channel partners.
• Regional leverage: a single technical dossier can be reused across Andean Community and Mercosur member states, spreading regional compliance cost.
• Full lifecycle support: end-to-end service from classification, pathway design and dossier preparation through certificate holding, customs clearance, post-market vigilance and renewal.

Contact

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