Ecuador Medical Device Registration 2026: Permiso de Funcionamiento and Establishment Licensing

1. Key takeaways

The operating permit (permiso de funcionamiento) is an establishment obligation, not a product obligation: Article 60 provides that establishments engaged in the manufacture, import, distribution, storage or commercialization of medical devices and in vitro diagnostic reagents must hold a valid operating permit issued by ARCSA and may only carry out the activities expressly stated in the permit document. Establishments engaged in manufacturing and importing must additionally place technical responsibility with a pharmaceutical chemist or a biochemical pharmaceutical chemist, whose degree must be registered with SENESCYT and recorded with ACESS. The permit sits upstream of every registration action a company takes in Ecuador, because the same establishment details reappear on the application form and must remain aligned throughout the review.

2. Legal basis

3. Expert insights

Insight 1: Article 60 lists five activities and confines the holder to the activities stated in the permit. Manufacturing, import, distribution, storage and commercialization: a permit holder that only holds a distribution permit but carries out importation is operating outside the permitted scope. This is the single most important point to check when vetting the qualifications of a channel partner, because out-of-scope activity exposes the whole supply chain, including the registrations distributed through that channel, to regulatory findings. The activity categories are printed on the permit document itself, so the check is documentary rather than declaratory.

Insight 2: The technical director qualification is a hard threshold, and it applies only to manufacturing and import. The second sentence of Article 60 provides that for manufacturing and import activities, technical responsibility must be borne by a pharmaceutical chemist or a biochemical pharmaceutical chemist, whose professional degree must be registered with SENESCYT or the corresponding body, and recorded with the national health authority through ACESS or the corresponding body. Distribution-only establishments are not required to engage such a professional, which makes the staffing profile of a partner a reliable indicator of what it is actually licensed to do.

Insight 3: Transitory general provision seven ties the operating permit to the submission information. The applicant information declared in the VUE system must match the information in the operating permit and the activities to be undertaken. This creates a three-way consistency requirement across the permit, the submission and the actual activity.

Insight 4: The operating permit number is a mandatory declaration item on the application form. Article 23(a) requires that the operating permit number (valid) be the first item of information declared at the time of application. An expired permit leads directly to the return of the application. Because review periods and deficiency responses run while the permit must stay alive, a permit that expires mid-review creates exactly the kind of avoidable failure that the single-deficiency-response rule does not forgive.

Insight 5: The split between domestic and imported products on system certificates runs parallel to the operating permit. Article 61 requires domestic manufacturing establishments to hold a BPM or ISO 13485 certificate issued by ARCSA, by a body recognized by SAE, or by an agency designated by MPCEI; Articles 62 and 63 provide that ISO 13485 certification on the domestic pathway must be registered with ARCSA. The operating permit and the system certificate are two independent obligations. A manufacturer entering the domestic pathway therefore faces both a site-level permit track and a system-level certificate track, and neither one advances the other, so the two should be scheduled in parallel from the outset.

Insight 6: The reform provisions amend the definitions of the regulations governing operating permits. Reform provision six (SEXTA) of the new regulation adds to the definitions section of Resolución ARCSA-DE-2023-001-AKRG (Registro Oficial No. 238, 2023-01-26, the technical sanitary regulation for issuing operating permits to establishments subject to health surveillance and inspection) the definition of professional related to medical devices (Profesional afín a dispositivos médicos). This confirms that the operating permit framework itself is being updated in step with the new device regulation, and that staffing and qualification terms should be checked against the amended definitions rather than against older commentaries.

4. Practical recommendations

1. Compare the activity categories line by line when verifying a holder’s operating permit, and confirm that import and distribution are both covered.
2. Confirm that the technical director’s SENESCYT registration and ACESS recording are current, and retain documentary evidence.
3. Keep a permit validity ledger, so that the permit remains valid throughout the entire submission and review cycle, including any deficiency response periods.
4. Cross-check the VUE declaration fields against the operating permit field by field, to avoid triggering transitory general provision seven.
5. Plan system certificates and ISO 13485 registration separately on the domestic pathway, and manage them independently of the operating permit.

5. Verification checklist

• □ The holder’s operating permit is valid and its activity scope covers import and distribution
• □ The technical director is a pharmaceutical chemist or a biochemical pharmaceutical chemist
• □ The technical director’s degree is registered with SENESCYT and recorded with ACESS
• □ The operating permit number has been entered correctly on the application form (Article 23(a))
• □ The VUE declaration has been cross-checked against the operating permit field by field
• □ System certificates and ISO 13485 registration have been planned separately on the domestic pathway

Regulatory information verified as of October 29, 2026

GRZAN service note

GRZAN provides regulatory support in this country for medical device manufacturers, importers and authorized representatives, covering registration pathway planning, operating permit verification and licensing structure design, technical director qualification checks, official fee and timeline estimation, technical dossier preparation, and post-market compliance management. Manufacturers and importers vetting an Ecuador channel partner or preparing a submission may contact GRZAN at info@grzanglobal.com for a tailored solution.