Ecuador Medical Device Registration 2026: Power of Attorney and the Authorization Chain

1. Key takeaways

The authorization chain rests on three provisions: Article 34(c) requires the simplified procedure to be supported by a legally authenticated letter of authorization from the product owner, empowering the applicant to obtain the registration certificate in Ecuador and clearly stating the powers conferred; Article 13 governs the language and authentication requirements for foreign legal documents; and Article 12 requires the technical document list to be electronically signed by a technical director based in Ecuador. Taken together, these provisions form a single continuous chain of authority that runs from the product owner all the way to the distributor, and a weakness at any link exposes the entire submission to a deficiency finding.

2. Legal basis

Substance of Article 12: technical documents must be submitted in Spanish or English; the technical documents must be listed in a letter electronically signed by the technical director in Ecuador; and that electronic signature must be verifiable for authenticity under Article 15 of the Law on Electronic Commerce, Electronic Signatures and Data Messages.

3. Expert insights

Insight 1: The core risk in a letter of authorization is an unclear description of powers, not the absence of a signature. The wording of Article 34(c) emphasizes that the document must state in a clear form the faculties that the product owner confers (en donde se exprese de forma clara las facultades que le otorga). Broad statements of general and sweeping representation may not be accepted; the powers should be enumerated item by item. A reviewer at ARCSA will read the document against the specific procedural acts it is meant to support, and a clause that merely appoints the applicant as attorney in fact leaves the scope open to interpretation and invites a deficiency notice during review.

Insight 2: Article 12 anchors the validity of the electronic signature in Article 15 of the Electronic Commerce Law. This means the signatory of the technical document list must be a technical director located in Ecuador, and the electronic signature must carry verifiable legal effect. A technical document list signed by the foreign manufacturer itself does not satisfy the requirement. The provision is procedural in form but substantive in effect: it forces every dossier to have a locally accountable signatory, which in turn means the applicant must have a functioning relationship with an Ecuador-based technical professional before the submission is even assembled.

Insight 3: The qualifications of the technical director are separately regulated in Article 60. Establishments engaged in manufacturing and import activities must place technical responsibility with a pharmaceutical chemist (químico farmacéutico) or a biochemical pharmaceutical chemist (bioquímico farmacéutico), whose professional degree must be registered with SENESCYT and recorded with the national health authority through ACESS. These qualifications cannot be substituted by general management experience or by engineering credentials issued abroad, so the availability of a properly credentialed technical director should be treated as a selection criterion when choosing the local entity that will hold the registration and submit the file.

Insight 4: Article 71 extends the authorization chain into the distribution tier. Representative offices and distributors must retain at their premises the registration holder’s authorization for their distribution and commercialization activities. The complete chain therefore runs: product owner, then registration holder under a duly authenticated power of attorney, then distributor under the holder’s authorization retained on site. Each tier generates its own document, and the documents must remain mutually consistent in scope, because an inspector comparing them will treat any mismatch as a finding against the holder.

Insight 5: The authentication exemption in Article 13 can in principle also apply to the letter of authorization. Where the content of a foreign public document can be verified on the official website of the issuing authority, ARCSA accepts the document without an apostille or consular legalization. In practice, however, a letter of authorization is issued by a company rather than a government body, so this exemption is rarely available and applicants should plan for formal authentication.

4. Practical recommendations

1. Enumerate the powers in the letter of authorization item by item: filing, submission, payment of fees, deficiency responses, renewal, changes, vigilance reporting, cancellation and related acts. Itemized drafting keeps the scope verifiable and avoids disputes about implied authority.
2. Confirm that the technical director meets the Article 60 qualifications (SENESCYT registration plus ACESS recording) and holds a valid electronic signature.
3. Have the technical document list signed by the technical director in Ecuador, not by an engineer on the Chinese mainland signing on their behalf, since a foreign signature has no anchor in Article 15 of the Electronic Commerce Law.
4. Maintain a three-tier authorization file covering product owner, registration holder and distributor, and update it on a fixed schedule so that documents never lapse silently.
5. Obtain an apostille or consular legalization for the letter of authorization, and attach a Spanish translation prepared in advance rather than at the customs stage.

5. Verification checklist

• □ The letter of authorization enumerates the conferred powers item by item
• □ The letter of authorization has been apostilled or consularly legalized
• □ A Spanish translation of the letter of authorization is attached
• □ The technical director holds SENESCYT registration and ACESS recording
• □ The technical document list has been electronically signed by the technical director in Ecuador
• □ The distributor has retained the holder’s distribution authorization on site

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, power of attorney and licensing structure design, authentication strategy for foreign legal documents, official fee and timeline estimation, technical dossier preparation, and post-market compliance management. Manufacturers and importers preparing an Ecuador submission or strengthening their authorization chain may contact GRZAN at info@grzanglobal.com for a tailored solution.