Ecuador ARCSA Audit: 3,939 Expired Licenses Highlight Risks Under Resolution 2026-003

In Ecuador, medical device and in vitro diagnostic (IVD) registrations are subject to strict validity timelines and renewal obligations. The regulatory body in charge—the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA)—has recently implemented a significant overhaul of its regulatory framework through the Resolution ARCSA-DE-2026-003-DASP, issued on April 28, 2026.

This new regulation, which replaces the decade-old Resolution ARCSA-DE-026-2016-YMIH, introduces stricter post-market control, clear rules for Software as a Medical Device (SaMD), and streamlined recognition for IMDRF-aligned approvals. However, it also enforces a strict 5-year registration validity that must be proactively renewed via the Ventanilla Única Ecuatoriana (VUE) system.

To evaluate compliance hygiene in this market, we conducted a database audit of the official ARCSA registry, specifically analyzing 3,939 expired registrations (registros sanitarios caducados). The findings reveal a significant wave of license expirations, highlighting the compliance risks manufacturers must manage during the ongoing transition period.

1. Quantitative Findings: Expired License Trends

An analysis of the ARCSA expired registration dataset indicates that 3,939 sanitary registrations for medical devices and biochemistry reagents have lapsed without renewal.

Expirations by Year

A breakdown of expirations by calendar year reveals a massive spike in 2025. This peak reflects two forces: a major regulatory cleanup by ARCSA, and the natural five-year expiration of the large wave of registrations filed during the 2020–2021 COVID-19 surge. Product-level inspection of the dataset shows the expired pool is dominated by surgical and procedure masks, protective apparel, respirators, and COVID-19 IgG serology test kits — the exact categories that flooded the registry between 2020 and 2021 and reached the end of their five-year validity in 2025. Many of these holders failed to complete the renewal (reinscripción) process under the older, more complex rules.

• Before 2018: 13 expired registrations
• 2018: 30 expired registrations
• 2019: 215 expired registrations
• 2020: 346 expired registrations
• 2021: 311 expired registrations
• 2022: 369 expired registrations
• 2023: 485 expired registrations
• 2024: 554 expired registrations
• 2025: 1,616 expired registrations

The dramatic increase to 1,616 expired licenses in 2025 shows that compliance enforcement has intensified. With the new Resolution 2026-003-DASP scheduled to enter into full force on January 28, 2027 (nine months post-signing), maintaining valid licenses is critical to preventing immediate import halts.

2. Manufacturer and Registration Holder Concentration

The expired licenses are highly concentrated among major local subsidiaries of multinational corporations and specialized regulatory representatives. The top 10 registration holders (titulares) by expired license volume account for a substantial portion of the total:

Analysis of Common Expired Products

The expired database consists of high-volume clinical consumables and diagnostic materials. The most frequent product families are personal protective and single-use items, followed by diagnostics and implants:

• Protective and single-use items: Surgical and procedure masks, protective apparel, and respirators (the single largest family by expired-license volume).
• IVD reagents: Immunoassay and rapid test kits, including COVID-19 IgG antibody serology kits and pregnancy/hCG rapid tests.
• Orthopedic implants: Surgical instruments for prosthesis implantation and joint replacement components.
• Cardiovascular consumables: Catheters designed specifically for angiography.

3. Regulatory Transition: Navigating Resolution ARCSA-DE-2026-003-DASP

The new Substitute Technical Health Regulation signed in April 2026 brings three major changes to the registration and renewal workflow. Manufacturers must adapt to these before the January 28, 2027 deadline:

A. The Renewal (Re-Registration) Window

Under the old system, registrations frequently fell into a backlog or were left to expire due to bureaucratic friction. Under the new resolution:

• Renewal applications must be submitted at least ninety (90) days (días término) before the current license expires, and no more than six (6) months prior.
• Failing to submit within this window results in the registration expiring (caducidad), requiring a full, new registration rather than a simplified renewal.

B. Simplified Recognition for IMDRF Approvals

To ease the regulatory burden, ARCSA now permits a simplified pathway for devices that hold active clearances or registrations from high-surveillance regulators (including members of the International Medical Device Regulators Forum, or IMDRF).

• The simplified review target is set at 30 business days (excluding clock-stops for observations).
• This pathway is a valuable backup route for manufacturers whose registrations have expired (caducados) and who need to regain market access quickly.

C. SaMD and Labeling Updates

• Software as a Medical Device (SaMD): Standalone medical software is now explicitly regulated based on risk classification.
• NDM017 Notification: A new electronic procedure must be completed for presenting final, approved labels via the VUE system.

Conclusion and Recommendations for Manufacturers

The audit of 3,939 expired registrations in Ecuador highlights the compliance pitfalls of neglecting local representation and registration lifecycles. To maintain market continuity during the transition to Resolution ARCSA-DE-2026-003-DASP, manufacturers should:

1. Map Expiration Dates Immediately: Cross-reference your active product list with the VUE/ECUAPASS database to identify any registrations expiring within the next 12 months.
2. Audit Your Local Holder (Titular): Ensure your local representative holds a valid operating permit (Permiso de Funcionamiento) and has the digital signature tokens required to initiate renewals.
3. Leverage the IMDRF Pathway: For critical products whose registrations have lapsed, compile Free Sale Certificates (FSC) and technical files from high-vigilance jurisdictions to utilize the 30-day simplified recognition route.

Sources

• Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) database: Base de datos - Catastros de DM y RB Cancelados, Suspendidos y Caducados (corte Septiembre 2025).
• Ecuador ARCSA Resolution ARCSA-DE-2026-003-DASP: Normativa Técnica Sanitaria Sustitutiva para la obtención del registro sanitario, control y vigilancia de dispositivos médicos de uso humano (April 2026).
• Ecuador ARCSA Resolution ARCSA-DE-2025-047-DASP (updates on sanitary registration exemptions).