Ecuador Medical Device GMP and ISO 13485 Evidence: Quality System Certificates under Article 24 Item 2.5

1. Key takeaways

The acceptable forms of quality system evidence in Ecuador are set by item 2.5 of Article 24, which offers 4 options: a valid device Good Manufacturing Practice (BPM) certificate or its equivalent; an ISO 13485 conformity certificate or a stricter one, applicable to imported products; an ISO 13485 certificate registered with ARCSA, applicable to domestically manufactured products; and an ISO 9001 certificate applicable only to pacifiers and feeding bottles. The certificate must be issued by the manufacturer of the manufacturing site, and the item is mandatory for all risk classes.

The practical estimate used by GRZAN is that quality system evidence is the element of the Ecuadorian dossier with the longest external lead time, because it depends on certification bodies rather than on the applicant itself. Companies that verify the certificate scope, validity and issuing body against the regulation before the submission window opens avoid the situation where a valid dossier waits for a piece of paper that could have been secured months earlier.

A second planning consequence follows from the four-option structure. Because the acceptable forms differ by origin of manufacture, the same product family manufactured at sites in two countries cannot share one system certificate across both registration routes: the imported route reads ISO 13485 or stricter, while the domestic route reads ARCSA-registered ISO 13485. Portfolio companies should therefore map every declared manufacturing site to its route at the very start of the project, and treat the certificate as part of the application architecture rather than as an attachment collected at the end.

2. Legal basis

Article 61 limits who may issue the system certificate for domestic manufacturers; Articles 62 and 63 govern the administrative registration of ISO 13485 certificates with ARCSA, which is an additional procedural layer for the domestic route; and Article 39 extends the same quality system evidence requirement to the renewal stage, for cases where the renewal is not automatic.

3. Expert insights

Insight one: imported and domestically manufactured products follow two different evidence paths. Imported products submit an ISO 13485 conformity certificate or a stricter one; the ISO 13485 submitted for domestic products must be registered with ARCSA under the procedure of Articles 62 and 63. The ARCSA registration is an additional administrative step on the domestic path and needs its own lead time.

Insight two: the certificate must be issued for the manufacturer of the production site, not for the group headquarters. The text refers to a conformity certificate issued by the manufacturer of the manufacturing site. This means that a group-level system certificate that does not cover the specific production site may be challenged. Where a product is made at several sites, each site must be covered individually.

Insight three: Article 61 restricts the issuing bodies for domestic manufacturers to three categories. The certificate may be issued by ARCSA itself, by a conformity assessment body accredited or recognised by SAE, or by a body designated by MPCEI. SAE is the Ecuadorian Accreditation Service and MPCEI is the Ministry of Production, Foreign Trade, Investment and Fisheries.

Insight four: the registration procedure of Article 62 allows two correction rounds. The registration is submitted through the document management system known as Quipux, and ARCSA reviews it for completeness; where corrections are needed the file is returned to the applicant with a correction period of 8 days and a maximum of two correction rounds. This gives the domestic path a clear procedural expectation.

Insight five: the scope of ISO 9001 is strictly limited. The text provides that the ISO 9001 quality certificate applies only to pacifiers and feeding bottles. This is a highly specific exception, which confirms by implication that every other product category must rely on BPM or ISO 13485 evidence.

Insight six: Article 39 extends system certificates to the renewal stage. Where the renewal is not automatic, the file must include a valid device BPM certificate or its equivalent, or the ISO 13485 applicable to imported products, or the ARCSA-registered ISO 13485 applicable to domestic products, or the ISO 9001 applicable only to pacifiers and feeding bottles. Quality system evidence is not a one-time material — it must be kept valid throughout the certification lifecycle.

4. Practical recommendations

1. Determine the certificate form by origin: imported products follow ISO 13485, domestic products follow ISO 13485 plus ARCSA registration; do not mix the two paths.
2. Verify the certificate scope: confirm that the certified entity includes the specific production site declared in the application, with a one-to-one mapping for multi-site manufacturing.
3. Start the ARCSA registration early on the domestic path: the Article 62 procedure includes up to two correction rounds of 8 days each and must be completed before submission.
4. Build a validity dashboard for system certificates: track first registration, the review window and the renewal as three checkpoints on the same timeline.
5. File pacifier and feeding bottle products separately: confirm the boundary of the ISO 9001 option to avoid using it outside its scope.

5. Verification checklist

• □ The form of the system certificate has been determined by origin of manufacture, imported or domestic.
• □ The certificate covers the specific production site declared in the application.
• □ On the domestic path, the ISO 13485 has been registered with ARCSA.
• □ The certificate remains valid for the entire review window.
• □ System certificate renewal has been included in the renewal plan.
• □ The boundary of the ISO 9001 option has been confirmed, applying only to pacifiers and feeding bottles.

Regulatory information verified as of October 29, 2026

GRZAN supports manufacturers, importers and authorised representatives selecting and maintaining quality system evidence for Ecuador medical device registration, from BPM and ISO 13485 scope checks to ARCSA certificate registration under Articles 62 and 63. For tailored assistance with your Ecuador medical device registration, contact us at info@grzanglobal.com.