Ecuador Post-Market Documentation Duties: Articles 67, 69 and 71 Inspection Readiness

1. Key takeaways

The post-market stage carries two duties of cooperation with inspections. Article 67 requires the holder to keep the technical documentation supporting every registration requirement of the regulation, which ARCSA may call for at any time it considers necessary. Article 71 requires the legal representative or technical director of a device representative office or distributor to keep the holder’s authorisation for distribution and commercialisation on the premises, so that ARCSA can verify it during surveillance and inspection.

A third duty, in Article 69, adds an environmental dimension: the collection, transport, treatment and final disposal of waste generated by device use and of device residues must follow the country’s environmental regulations in force, and compliance is verified through follow-up and inspection visits to the premises concerned.

All three provisions describe obligations that exist whether or not an inspection occurs. They are not filing steps with a submission receipt; they are conditions of the premises that an inspector can test on the day of the visit.

2. Legal basis

Substance of Article 67: the holder of a medical device registration certificate must keep all technical documentation supporting the registration requirements set out in the regulation, and ARCSA may require it at any time it considers necessary.

Substance of Article 69: the collection, transport, treatment and final disposal of waste generated by device use and of device residues follow the environmental regulations in force in the country, and are verified through follow-up and inspection of the premises concerned.

3. Expert insights

Insight one: Article 67 converts the technical file from a submission into a standing obligation. Most companies treat the technical file as material that is archived once the certificate is issued. Article 67 requires it to be available on demand. A missing file is itself a breach of Article 67, which puts the sanction channel of Article 72 in reach without any product defect being alleged.

Insight two: the duty sits with the holder, but the documents originate with the manufacturer. The holder must possess the full file, and that file is normally produced by the manufacturer. The holder agreement therefore needs explicit terms on delivery, updating and custody, including what happens when the manufacturer revises a test report or a label after approval.

Insight three: Article 71 requires the authorisation to be on the premises. The text requires representative offices and distributors to keep the holder’s authorisation at the establishment (en el establecimiento) for verification during surveillance and inspection. An electronic archive that cannot be produced on site may not satisfy the requirement, so a paper original kept where the inspector stands is the safer reading.

Insight four: Article 69 introduces an environmental compliance dimension. Waste from device use and device residues must be collected, transported, treated and finally disposed of in accordance with the environmental rules in force, and that compliance is checked at the premises. The operational burden usually falls on healthcare institutions and distributors, but the manufacturer is expected to supply disposal instructions in the instructions for use.

Insight five: the sample return under Article 66 is a detail that follows from the inspection duty. Samples drawn during an inspection are returned by the holder to the place where they were drawn, except where the inspection takes place at the holder’s own premises. That requires a logistics and record process that exists before the inspection, not after it.

Insight six: together the three duties constitute inspectability. The technical file under Article 67, the distribution authorisation under Article 71 and the sample return under Article 66 describe one capability: being able to answer an inspector on the day. That capability is itself an object of compliance assessment, and it is the one most often missing when a technically sound product is sanctioned.

4. Practical recommendations

1. Set out the delivery, updating and custody of the technical file in the holder agreement, with a continuing supply obligation on the manufacturer.
2. Version-control the technical file so that the copy produced to ARCSA is demonstrably the current one.
3. Keep distributor authorisations as paper originals at each premises, and check their validity dates on a fixed cycle.
4. Include waste disposal instructions in the instructions for use to support the environmental requirement in Article 69.
5. Establish a logistics and record process for sample return, so that Article 66 can be executed within the inspection timetable.

5. Verification checklist

• □ The holder agreement covers delivery, updating and custody of the technical file
• □ The technical file is version-controlled and can be produced on demand
• □ Distributor authorisations are kept as paper originals at each premises
• □ The instructions for use contain waste disposal guidance (Article 69)
• □ A logistics and record process for sample return has been established
• □ A full copy of the technical file has been delivered to the holder and is updated periodically

Regulatory information verified as of October 29, 2026

GRZAN core service lines

1. Global registration access: EU CE (MDR/IVDR), US FDA (510(k)/De Novo/PMA), UK UKCA, Australia TGA, Canada Health Canada, Brazil ANVISA and Russia RZN, together with pre-market registration pathway planning and submission execution across Latin America, Southeast Asia and the Middle East.
2. Authorized representative services: EU EC REP, UK RP, Swiss CH REP, Australian sponsor and US Agent holding and representation services, with support for neutral license-holder structures.
3. Quality system compliance: ISO 13485 establishment and maintenance, MDSAP audit preparation, GMP conformity coaching, and technical documentation (TD) drafting and remediation.
4. Clinical and evaluation support: clinical evaluation plans (CEP) and reports (CER), equivalence argumentation, PMCF planning and execution, and IVD performance evaluation.
5. Post-market compliance: vigilance and adverse event reporting, FSCA and recall execution, registration change and renewal management, and maintenance of national regulatory databases.

Why manufacturers choose GRZAN

• Local regulatory teams: target-market work is performed by locally licensed regulatory professionals, and submission dossiers are written directly in the local official language without secondary translation.
• Neutral license-holder structures: GRZAN offers holding arrangements that are not tied to any distribution channel, preventing registration certificates from being locked in by channel partners.
• Regional leverage: one technical dossier can be reused across Andean Community and Mercosur member states, spreading regional compliance costs.
• Full lifecycle support: from classification determination and pathway design through dossier preparation, license holding, customs clearance, post-market vigilance and renewal.

Contact

• GRZAN provides registration support in Ecuador for manufacturers, importers and authorized representatives.
• Email: info@grzanglobal.com
• Service inquiries: Ecuador and Andean market registration plans, license-holder structure design, official fee and timeline estimation