Ecuador Simplified Registration Pathway: Replacing Resolución ARCSA-DE-030-2018-JCGO under the 2026 Regulation

1. Key takeaways

The current simplified registration basis, Resolución ARCSA-DE-030-2018-JCGO (Registro Oficial No. 416, published 2019-01-29), will be repealed on 2027-01-28 together with the current core regulation, and replaced by the IMDRF recognition channel of Articles 31–35 of the new regulation. The core change is that the recognition standard shifts from a list of specific countries to a dual test of high vigilance agency plus IMDRF membership, and the scope of application extends to all risk classes I–IV. Companies holding reference registrations issued by agencies that fail either limb of the test will lose access to the fast lane and must plan the general route in advance.

2. Legal basis

3. Expert insights

Insight 1: the recognition standard of the new channel is agency status, not a country list, and this is the most important rule change. Article 31 provides that ARCSA recognizes registration certificates or equivalent documents issued by agencies that are high vigilance agencies and at the same time IMDRF members. Article 3 defines high vigilance agencies (Agencias de alta vigilancia) as regulatory authorities designated by PAHO/WHO as Regional Reference Authorities (Autoridades de Referencia Regional) and agencies regarded by WHO as Strict Regulatory Authorities (Autoridades Reguladoras Estrictas). The two limbs are parallel: an agency meeting either one satisfies the status requirement.

Insight 2: this way of defining the standard produces three practical conclusions.

• The list is dynamic: the official text does not enumerate specific agencies, and the test moves with PAHO/WHO designations. FDA, EMA, Health Canada, TGA and ANVISA should be understood as current examples that happen to meet the standard, not as a statutory list;
• The burden of proof changes: an applicant cannot merely assert that the certificate comes from a particular country, but must evidence that the issuing agency currently holds RRA or SRA status;
• The NMPA of China is currently outside the scope of this definition: Chinese manufacturers should enter the simplified channel through a legal entity or product that already holds registrations issued by qualifying agencies.

Insight 3: the three eligibility conditions of Article 32 are cumulative and none can be missing.

1. The device must be commercialized in an IMDRF Management Committee member jurisdiction, and the registration or authorization obtained must have been granted in its capacity as a medical device;
2. The device must be classified by ARCSA as class I, II, III or IV;
3. The entry cap per application form: 100 entries for DMI/DMNI/DMA and 50 entries for DMDIV.

Insight 4: the 6-item information list of Article 34 shows what simplified really means. The items are: (a) a letter signed electronically by the applicant electing the simplified procedure; (b) a registration certificate or equivalent document issued by a high vigilance agency under Article 31; (c) a legally authenticated authorization from the product owner authorizing the applicant to obtain the Ecuadorian registration certificate, which must clearly state the powers granted; (d) the CLV or an equivalent document; (e) the instructions for use or user manual; (f) the draft label or label, printed in clear and indelible characters and presented as it will be marketed in Ecuador. Compared with the current regime, the new list moves most evidentiary weight onto a single recognized certificate plus a compliant power of attorney.

Insight 5: during the transition the simplified procedure uses the homologation application form, an operational detail given by Article 35(1). The original text provides that the applicant shall submit the simplified procedure application through VUE/ECUAPASS, in the homologation application form (formulario de homologación), until the VUE system is updated. Before filing, confirm the form version currently applicable in VUE. Filing on the wrong form is an avoidable completeness rejection at step one.

Insight 6: the difference in dossier intensity between the old and new channels is significant. The current simplified path under 030-2018-JCGO requires a comparatively complete dossier up front; the new regulation adopts a two-stage structure of 6 items to enter plus completion within 30 days, deferring most documentation work to after the certificate is granted. This is the most substantive process design change of the new channel, and it rewards applicants whose post-approval document supply chain is already organized.

4. Practical recommendations

1. Judge high vigilance agency status strictly against the Article 3 definition and do not rely on any fixed list.
2. Verify that the reference certificate was granted in its capacity as a medical device: approvals under pharmaceutical or dietary supplement pathways do not satisfy Article 32(1).
3. Confirm actual commercialization in an IMDRF Management Committee member jurisdiction: a certificate without sales evidence does not satisfy the condition.
4. Calculate the entry caps separately for DMDIV and devices (50/100 entries) to avoid rejection for exceeding the limits.
5. Treat the current simplified path as a transition option: if the product can meet the current conditions before 2027-01-28, obtain the certificate under the current regime first.

5. Verification checklist

• □ Verified the current RRA or SRA status of the intended agency against the Article 3 definition
• □ Confirmed that the agency is an IMDRF member
• □ Prepared evidence of commercialization in an IMDRF Management Committee member jurisdiction
• □ Confirmed that the reference registration was granted as a medical device
• □ Completed the independent ARCSA classification (I/II/III/IV)
• □ Checked the entry caps by device type (50 for DMDIV / 100 for the rest)
• □ Confirmed the form version currently applicable in VUE (standard form / homologation form)

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