Ecuador Medical Device Registration 2026: Registration Holder (Titular) Structure and Responsibilities

1. Key takeaways

Ecuador applies a registration holder (Titular del Registro Sanitario) system for medical devices: under Article 5, the sanitary registration certificate is issued in the name of the registration holder, who is responsible for its use; Article 3 defines the holder as the natural or legal person to whom ARCSA grants the registration certificate; and Article 19 makes the holder answerable both for the truthfulness of the information it provides and for compliance with technical and sanitary requirements across manufacturing, storage, distribution, transport and sale of the devices registered under its name. Foreign manufacturers must hold their registrations through a local registration holder.

2. Legal basis

Core definitions under Article 3:

• Registration holder (Titular del Registro Sanitario): the natural or legal person to whom ARCSA grants the sanitary registration certificate;
• Product owner (Titular del producto): the natural or legal person that owns the product and places it on the market, which may be the manufacturer itself or a third party duly authorized by the manufacturer;
• Authorized representative (Representante autorizado): the natural or legal person duly authorized by the product owner to act on its behalf in Ecuador;
• Manufacturer (Fabricante): the natural or legal person that designs, produces, manufactures, assembles and finishes finished devices and commercializes them under its own name, and that is responsible for the design, manufacture, packaging and labeling of the devices, whether these operations are carried out by that person or by a third party.

3. Expert insights

Insight 1: Article 3 defines the product owner and the registration holder separately, and the two roles may be held by different entities. The product owner is the rights holder in the commercial sense, which may be the manufacturer or a third party authorized by it, while the registration holder is the responsible party in the regulatory sense. The new regulation does not require the two roles to be held by the same person, which preserves structural space for manufacturers from the Chinese mainland to remain the product owner themselves while a local entity serves as the registration holder.

Insight 2: Article 5 binds the name on the certificate to the responsibility for its use. The text provides that the sanitary registration will be issued in the name of the registration holder, that the holder will be responsible for its use, and that the uniform format approved by ARCSA will be adopted. This means the name printed on the certificate is the party that bears regulatory liability, and a foreign manufacturer cannot defend itself against the regulator by pointing to contractual indemnity clauses agreed with the holder.

Insight 3: The scope of responsibility under Article 19 covers five stages of the product life cycle. Manufacturing, storage, distribution, transport and sale: the registration holder is responsible for compliance with technical and sanitary requirements in all five stages, and not merely for the truthfulness of the submitted dossier. In practice this makes the holder an active compliance operator with duties that continue for as long as the devices remain on the market.

Insight 4: The operating permit constitutes a substantive threshold for any would-be registration holder. Article 23(a) requires the applicant to declare a valid operating permit number at the time of filing, and Article 60 requires any establishment engaged in manufacturing, import, distribution, storage or commercialization to hold a valid operating permit and to confine itself to the activities expressly listed in the permit document. An entity without a valid operating permit cannot act as a qualified registration holder.

Insight 5: Article 71 extends the holder’s responsibility into the distribution channel. The legal representative or technical director of device representative offices and distributors must keep, at their premises, the authorization issued by the registration holder for that distributor or office to distribute and commercialize the devices, so that ARCSA can verify it during surveillance and inspection activities. This creates a documented management obligation that runs from the registration holder down through every downstream channel partner.

4. Practical recommendations

1. Clearly separate the product owner and the registration holder in the authorization structure, keeping the product owner as the entity on the side of the Chinese mainland.
2. Verify the holder’s operating permit before signing: confirm that the permit is valid and that its listed scope of activities covers import and distribution.
3. Define the holder’s specific compliance obligations for each of the five stages in the agreement, rather than relying on a general liability clause.
4. Require the holder to establish an authorization management mechanism for downstream distributors, so that the on-site verification requirements of Article 71 can be met at any time.
5. Evaluate a neutral registration holder structure: the certificate does not move when the distribution channel changes, which materially reduces channel risk.

5. Verification checklist

• □ The roles of product owner and registration holder have been defined
• □ The validity and activity scope of the holder’s operating permit have been verified
• □ The agreement sets out the holder’s compliance obligations across the five stages
• □ A mechanism to retain and verify downstream distributor authorizations is in place
• □ The suitability of a neutral registration holder structure has been assessed
• □ The certificate format has been confirmed against the uniform format required by ARCSA

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, registration holder and licensing structure design, operating permit and BPADT verification, official fee and timeline estimation, technical dossier preparation, and post-market compliance management. Manufacturers and importers planning an Ecuador registration or restructuring an existing licensing arrangement may contact GRZAN at info@grzanglobal.com for a tailored solution.