Ecuador Medical Device Regulation ARCSA-DE-2026-003-DASP: Structure, Effective Date and Repeals

1. Key takeaways

Resolución ARCSA-DE-2026-003-DASP, formally the Replacement Sanitary Regulation for the Sanitary Registration, Control and Surveillance of Medical Devices for Human Use, was signed in Guayaquil on 2026-04-28 by the ARCSA Executive Director Daniel Antonio Sánchez Procel and enters into force, under its final provision, 9 months after signature, that is on 2027-01-28. The full text contains 16 chapters and 72 articles, restructuring the registration system along five dimensions: classification, pathways, technical documentation, premises and post-market control, and expressly repeals the current core regulation together with 5 amending resolutions. Understanding the chapter architecture is the fastest way to map internal compliance processes onto the new regime.

2. Legal basis

3. Expert insights

Insight 1: the chapter structure is itself a compliance map. The 16 chapters cover, in order: general provisions and scope (Articles 1–2); definitions and abbreviations (Articles 3–4); sanitary registration (Articles 5–19); common requirements (Articles 20–30); general procedure registration (Article 26); simplified procedure registration (Articles 31–36); renewals (Articles 37–41); variations (Articles 42–45); voluntary cancellation (Articles 46–47); packaging, labeling and instructions for use (Articles 48–57); domestic conditioning and pilot batches (Articles 58–59); premises operating permits (Article 60); domestic production system requirements (Article 61); ISO 13485 registration (Articles 62–63); post-registration control and vigilance (Articles 64–71); and sanctions (Article 72). Assigning an internal owner to each chapter converts the regulation into a workable responsibility matrix.

Insight 2: the scale of restructuring is uneven across the five dimensions, which is the basis for setting priorities.

• Classification: a shift from reliance on the old rules to classification in accordance with ARCSA instructions and GHTF/IMDRF rules (Article 22 and general provision 3);
• Pathways: a new simplified channel covering all classes I–IV (Articles 31–33);
• Technical documentation: tiered application according to a device type by risk class matrix (Article 24);
• Premises: operating permits, good manufacturing practice and ISO 13485 registration running in parallel (Articles 60–63);
• Post-market: post-registration control is expressly split into Type 1 and Type 2 tiers (Article 65).

Insight 3: the identity of the signatory and the full name of the agency are verification points. The signature block reads Dr. Daniel Antonio Sánchez Procel, Mgs., Executive Director of ARCSA (Doctor Leopoldo Izquieta Pérez), signed in Guayaquil; his appointment is based on Acción de personal Nro. 00107-ARCSA-DTH-2024, effective from 2024-03-04. Checking these three elements against the official publication protects against acting on altered or counterfeit copies of the resolution.

Insight 4: the wording of the entry-into-force provision means the effective date is not affected by publication delays. The final provision states that the regulation takes effect upon expiry of a 9-month period counted from the date of signature, without prejudice to its publication in the official gazette. This anchors the effective date to the signature date: even if gazette publication is delayed, the regulation still enters into force on 2027-01-28. Project plans should therefore not be adjusted on the basis of publication timing speculation.

Insight 5: the repeal list covers the entire current regime but preserves one notification document and expands it. Repeal provision item 1 lists 026-2016-YMIH together with its 4 amendments, and item 2 repeals 2023-033-AKRG. By contrast, 2023-005-AKRG (the notification regime) is not repealed and is in fact amended by amending provision 7 to add NDM017. Companies operating notification-track products must not assume wholesale repeal.

Insight 6: the transitional provisions create two arrangements favorable to industry. Transitional provision 1 requires ARCSA to issue the implementing instructions within 9 months of signature; provision 2 provides that ARCSA will proactively reclassify existing valid certificates, that holders may also apply proactively, and that no fee is charged for such applications. These provisions materially reduce the compliance cost of the classification migration and should be used before the window closes.

4. Practical recommendations

1. Build the internal compliance manual on the 16-chapter structure, assigning an owner and timeline to each chapter.
2. Plan the project backwards from 2027-01-28, front-loading dossier rework, reclassification reviews and instruction monitoring.
3. Verify official documents by checking the signatory, the full agency name and the place of signature as three matching elements.
4. Create an old-to-new provision mapping table, mapping each current operating practice to the corresponding article of the new regulation.
5. Track the implementing instructions required by the transitional provisions and complete an internal gap analysis within 30 days of each issuance.

5. Verification checklist

• □ Obtained the official gazette text of the new regulation (16 chapters and 72 articles)
• □ Checked the signatory, the full agency name and the place of signature
• □ Confirmed the effective date of 2027-01-28
• □ Built the old-to-new provision mapping table
• □ Set up tracking of ARCSA implementing instructions
• □ Built the internal compliance manual on the chapter structure

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