Ecuador Single-Use Devices and the Ban on Fractioning: General Provisions Ten to Twelve

1. Key takeaways

The new regulation adds two prohibitions in its general provisions. General provision ten (DECIMA) provides that devices whose label, instructions for use and/or user manual carries the single use only (un solo uso) symbol may not be reused in public or private healthcare institutions anywhere in the country. General provision eleven (DECIMA PRIMERA) prohibits the fractioning (fraccionamiento) of devices: commercialisation must follow the commercial presentation approved by ARCSA.

The two provisions work on different actors. The reuse ban binds healthcare institutions at the point of clinical use; the fractioning ban binds whoever puts the product on the market, and it converts the approved presentation from a commercial preference into a regulatory boundary.

Both provisions rely on definitions and declarations made earlier in the lifecycle. Article 3 defines a single-use device as one intended by the manufacturer for use in a single procedure on a single patient, after which it is discarded, and Article 23, item (f) requires the commercial presentation and/or model or reference to be declared at filing. What is fixed at filing becomes the limit after approval.

2. Legal basis

3. Expert insights

Insight one: general provision ten binds healthcare institutions, not manufacturers. The text states that devices bearing the single use only (un solo uso) symbol on the label, instructions for use and/or manual may not be reused in public or private healthcare institutions nationwide. Once the symbol is applied, a mandatory obligation is triggered at the clinical end, and the market space for reprocessing and reusing the device is closed indirectly.

Insight two: general provision ten pairs with Article 49, item (m), sub-item 3. Article 49 requires the label to carry the disposable or non-reusable (Producto desechable o no reusable) symbol for devices that are sterile and not reusable. Read together, the two provisions lock a sterile, non-reusable device at both ends: the label declares the status, and the institution is barred from reuse.

Insight three: general provision eleven prohibits fractioning against the approved presentation. The text prohibits fractioning (fraccionamiento) of devices for human use and requires commercialisation in accordance with the commercial presentation approved by ARCSA. A product imported in a full carton therefore cannot be broken down and sold in units, unless the broken-down packaging has itself been approved.

Insight four: Article 23, item (f) makes the benchmark a declared item. The application must state the commercial presentation and/or the model or reference. Because the approved presentation is definite, the test for whether a sale amounts to fractioning is also definite, and it is not a matter of local commercial custom.

Insight five: Article 42, item (h) provides the lawful route to adjust the presentation. That article lists a change, addition or removal of the commercial presentation among the situations that do not require re-registration and are handled through the change procedure. A company that genuinely needs to sell in smaller units should obtain approval through that route rather than splitting stock in the warehouse.

Insight six: general provision twelve opens an expert review channel. ARCSA may convene its internal advisory committee (CAI) or an external expert committee (CEE) at any stage of registration, whether ordinary or simplified, or of a change application, and the report issued serves as the basis for the regulatory decision. For a technical dispute about presentation, sterility or reuse, that is the structured route to a reasoned outcome.

4. Practical recommendations

1. Apply the single use only symbol deliberately: it triggers the reuse ban at the clinical end, so the marking must match the product positioning and the validated reprocessing status.
2. Sell in the approved commercial presentation, and do not break bulk cartons into units for distribution.
3. Where fractioning is genuinely required, obtain approval through the change procedure under Article 42, item (h) before selling.
4. Write the no-fractioning obligation into distributor agreements, with a defined remedy for breach.
5. In a technical dispute, assess whether to invoke general provision twelve and ask ARCSA to convene an expert committee.

5. Verification checklist

• □ Whether the product carries the single use only symbol, and its consequences, have been confirmed
• □ The sales format has been checked against the commercial presentation approved in the certificate
• □ Distributor agreements state the no-fractioning obligation
• □ Any requirement to sell in smaller units has been filed through the change procedure
• □ The route for invoking the CAI or CEE expert review mechanism is understood
• □ The end-use restriction on single-use devices has been explained to customers

Regulatory information verified as of October 29, 2026

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