Ecuador medical device regulations

Annex 4 section 4.1 treats commercial-name changes separately from section 4.18 brand change/inclusion/exclusion. Commercial-name evidence includes updated Spanish labeling (with the biomedical-equipment marking exception), owner certification of the name change and unchanged quality/specifications, the specified domestic/foreign legal evidence, updated insert/manual/technical sheet, and legalized CLV bearing the new name. Brand evidence includes updated label, a justification letter issued by the titular or manufacturer, and, for foreign products when applicable, competent-authority CLV/equivalent declaring the new brand with the stated legalization.

DM02 NDM06 covers label/insert/manual updates that do not modify approved information content and concern form only, except updates requested by ARCSA as stated in the table. For insert/manual and label changes, supply a detailed justification, a current/proposed comparison and the proposed insert/manual or label respectively. This source does not convert changed brand/manufacturer/model content into a cosmetic notification.

DM02 requires listed notification events to be notified within sixty working days after they occur; “término” is defined as working days. An unfavorable notification-document review is returned once for applicant correction within five working days, otherwise the application is cancelled; a second unfavorable review also requires abandonment/re-filing as specified. Mixed-filing review depends on complexity, risk and device type. These are notification filing/cure rules, not an empirical best/expected/worst approval duration or a fixed authority review promise.

Annex 4 allows only the label/insert changes corresponding to the modification requested; the rest must match prior approval, otherwise file the corresponding label/insert update. Section 4.15 requires changed insert/manual, an explanatory letter and current/proposed comparison. Section 4.16 requires new label artwork, explanatory letter (with the stated biomedical-equipment exception/marking requirements) and current/proposed comparison. Cosmetic-only NDM06 is a separate narrow notification branch.

The 2026 tariff page 10 distinguishes specified modifications requiring technical analysis at 20% of the applicable registration amount from enumerated non-analytical modifications at 10%; its 10% list includes product-name and manufacturer/applicant company-name changes. The residual provision charges modifications not listed in Ministerial Agreement 112 at 10%, subject to the express exceptions, including sanitary-registration notifications governed by the applicable product rules. The listed brand-inclusion row expressly concerns foods/cosmetics and is not a device-brand fee rule. Page 9 lists different registration bases: national medical devices USD 678.25, foreign medical devices USD 904.34 and biochemical reagents USD 678.25; it does not establish that every IVD is a biochemical reagent.

DM02 NDM09 concerns stock exhaustion for changes previously approved. The table requires a justification letter describing the reason and the requirements established by the applicable current rule. This passage proves a conditional notification channel after change approval; it does not establish an automatic stock sell-through grace period, the permitted duration, or permission to implement an unapproved change.

The residual modification-fee rule in the 2026 ARCSA tariff expressly excludes notifications to the sanitary registration and updates to notifications/NSO, to be applied under the relevant product rules. For medical-device notification cases, eligibility must first be established under DM02; mixed applications remain charged on their modification items.

Annex 4 section 4.6 requires updated manufacturer-name labels (subject to the biomedical marking exception), foreign competent-authority CLV/equivalent certifying the company-name change with legalization or domestic chamber/mercantile evidence, a manufacturing contract bearing the new name when applicable, and the specified BPM/ISO 13485 evidence. The supporting quality certificate must justify the company-name change without change to the facilities’ address. This is distinct from replacing the principal manufacturer under section 4.3.

Annex 4 allows only the label/insert changes corresponding to the modification requested; the rest must match prior approval, otherwise file the corresponding label/insert update. Section 4.15 requires changed insert/manual, an explanatory letter and current/proposed comparison. Section 4.16 requires new label artwork, explanatory letter (with the stated biomedical-equipment exception/marking requirements) and current/proposed comparison. Cosmetic-only NDM06 is a separate narrow notification branch.

The 2026 tariff page 10 distinguishes specified modifications requiring technical analysis at 20% of the applicable registration amount from enumerated non-analytical modifications at 10%; its 10% list includes product-name and manufacturer/applicant company-name changes. The residual provision charges modifications not listed in Ministerial Agreement 112 at 10%, subject to the express exceptions, including sanitary-registration notifications governed by the applicable product rules. The listed brand-inclusion row expressly concerns foods/cosmetics and is not a device-brand fee rule. Page 9 lists different registration bases: national medical devices USD 678.25, foreign medical devices USD 904.34 and biochemical reagents USD 678.25; it does not establish that every IVD is a biochemical reagent.

Annex 4 section 4.9 requires foreign competent-authority CLV/equivalent certifying the address change with legalization, ISO/BPM showing the new address, updated internal/external labels (biomedical marking exception), a manufacturer-address notification letter, and a domestic operating permit showing the new address for national manufacture. If the event also changes manufacturing process, the holder must file a process-update modification. Section 4.8 separately governs a product owner’s address when that owner is the principal manufacturer/site.

DM02 NDM05 covers a product-owner address change only when that owner is not the principal manufacturer or manufacturing site. Domestic evidence includes explanatory letter and operating permit at the new address; foreign evidence includes explanatory letter, competent-authority CLV/equivalent when applicable with the stated legalization/verifiable-electronic exception, and a power stating the new address and the holder’s powers. NDM07 covers a domestic registration-holder/applicant address only when it is not the principal manufacturer/site, with notification letter and updated operating permit. The corresponding manufacturer/site address cases are modifications under DM01.

DM02 requires listed notification events to be notified within sixty working days after they occur; “término” is defined as working days. An unfavorable notification-document review is returned once for applicant correction within five working days, otherwise the application is cancelled; a second unfavorable review also requires abandonment/re-filing as specified. Mixed-filing review depends on complexity, risk and device type. These are notification filing/cure rules, not an empirical best/expected/worst approval duration or a fixed authority review promise.

Annex 4 allows only the label/insert changes corresponding to the modification requested; the rest must match prior approval, otherwise file the corresponding label/insert update. Section 4.15 requires changed insert/manual, an explanatory letter and current/proposed comparison. Section 4.16 requires new label artwork, explanatory letter (with the stated biomedical-equipment exception/marking requirements) and current/proposed comparison. Cosmetic-only NDM06 is a separate narrow notification branch.

The 2026 tariff page 10 distinguishes specified modifications requiring technical analysis at 20% of the applicable registration amount from enumerated non-analytical modifications at 10%; its 10% list includes product-name and manufacturer/applicant company-name changes. The residual provision charges modifications not listed in Ministerial Agreement 112 at 10%, subject to the express exceptions, including sanitary-registration notifications governed by the applicable product rules. The listed brand-inclusion row expressly concerns foods/cosmetics and is not a device-brand fee rule. Page 9 lists different registration bases: national medical devices USD 678.25, foreign medical devices USD 904.34 and biochemical reagents USD 678.25; it does not establish that every IVD is a biochemical reagent.

The residual modification-fee rule in the 2026 ARCSA tariff expressly excludes notifications to the sanitary registration and updates to notifications/NSO, to be applied under the relevant product rules. For medical-device notification cases, eligibility must first be established under DM02; mixed applications remain charged on their modification items.

Annex 4 section 4.12 permits model-change modification only without affecting risk level, use or approved characteristics. It requires the manufacturer’s technical justification expressly addressing those points, updated internal/external labeling with the biomedical marking exception, and an insert with the new model. Annex 4 section 3 requires a new registration for the specified type/model/intended-use/conditions/composition/energy changes generating a risk-level change and for the stated formulated/drug-combination formula changes. DM02 explicitly defines its “Código de referencia” as an ARCSA service/form code unrelated to manufacturer product codes/references. No pure internal SMN/reference-change route is established by these passages.

Annex 4 allows only the label/insert changes corresponding to the modification requested; the rest must match prior approval, otherwise file the corresponding label/insert update. Section 4.15 requires changed insert/manual, an explanatory letter and current/proposed comparison. Section 4.16 requires new label artwork, explanatory letter (with the stated biomedical-equipment exception/marking requirements) and current/proposed comparison. Cosmetic-only NDM06 is a separate narrow notification branch.

The 2026 tariff page 10 distinguishes specified modifications requiring technical analysis at 20% of the applicable registration amount from enumerated non-analytical modifications at 10%; its 10% list includes product-name and manufacturer/applicant company-name changes. The residual provision charges modifications not listed in Ministerial Agreement 112 at 10%, subject to the express exceptions, including sanitary-registration notifications governed by the applicable product rules. The listed brand-inclusion row expressly concerns foods/cosmetics and is not a device-brand fee rule. Page 9 lists different registration bases: national medical devices USD 678.25, foreign medical devices USD 904.34 and biochemical reagents USD 678.25; it does not establish that every IVD is a biochemical reagent.

Annex 4 section 4.2 product-owner change requires a reason document from owner/manufacturer, a public deed transferring product ownership from old to new owner or equivalent with recognized signatures and foreign legalization, and new-owner authorization/power for the current applicant. Sections 4.4 and its continuation address changing the applicant: product-owner authorization/power to the new applicant and revocation of the former applicant’s power (foreign legalization), updated labels when applicable, technical-representative notification/employment evidence, and notarized registration-rights assignment/equivalent. Include a responsible-technical-person change in the modification detail when involved. These are distinct actors and evidence sets.

COMEX 017-2025 replaces Article 4 to require ARCSA express authorization before using or modifying the relevant sanitary registration/notification for import. It prohibits endorsements, assignments and transfers that have not been processed and authorized by ARCSA. It does not prohibit every authorized transfer. The transitional provision required affected operators to complete the applicable authority procedure even where holder consent previously existed.

The 2026 tariff page 10 distinguishes specified modifications requiring technical analysis at 20% of the applicable registration amount from enumerated non-analytical modifications at 10%; its 10% list includes product-name and manufacturer/applicant company-name changes. The residual provision charges modifications not listed in Ministerial Agreement 112 at 10%, subject to the express exceptions, including sanitary-registration notifications governed by the applicable product rules. The listed brand-inclusion row expressly concerns foods/cosmetics and is not a device-brand fee rule. Page 9 lists different registration bases: national medical devices USD 678.25, foreign medical devices USD 904.34 and biochemical reagents USD 678.25; it does not establish that every IVD is a biochemical reagent.

DM02 requires listed notification events to be notified within sixty working days after they occur; “término” is defined as working days. An unfavorable notification-document review is returned once for applicant correction within five working days, otherwise the application is cancelled; a second unfavorable review also requires abandonment/re-filing as specified. Mixed-filing review depends on complexity, risk and device type. These are notification filing/cure rules, not an empirical best/expected/worst approval duration or a fixed authority review promise.

The 2026 tariff page 10 distinguishes specified modifications requiring technical analysis at 20% of the applicable registration amount from enumerated non-analytical modifications at 10%; its 10% list includes product-name and manufacturer/applicant company-name changes. The residual provision charges modifications not listed in Ministerial Agreement 112 at 10%, subject to the express exceptions, including sanitary-registration notifications governed by the applicable product rules. The listed brand-inclusion row expressly concerns foods/cosmetics and is not a device-brand fee rule. Page 9 lists different registration bases: national medical devices USD 678.25, foreign medical devices USD 904.34 and biochemical reagents USD 678.25; it does not establish that every IVD is a biochemical reagent.

DM02 NDM09 concerns stock exhaustion for changes previously approved. The table requires a justification letter describing the reason and the requirements established by the applicable current rule. This passage proves a conditional notification channel after change approval; it does not establish an automatic stock sell-through grace period, the permitted duration, or permission to implement an unapproved change.

The residual modification-fee rule in the 2026 ARCSA tariff expressly excludes notifications to the sanitary registration and updates to notifications/NSO, to be applied under the relevant product rules. For medical-device notification cases, eligibility must first be established under DM02; mixed applications remain charged on their modification items.