Ecuador Medical Device Regulation 2026: BPADT Good Practices for Storage, Distribution and Transport

1. Key takeaways

Good practices for storage, distribution and transport (BPADT) became a mandatory obligation under transitory general provision six of the new regulation: establishments that store, distribute or transport medical devices must hold a good practices certification in accordance with the applicable regulation. Its parent regulation is Resolución ARCSA-DE-002-2020-LDCL (Registro Oficial Edición Especial No. 455, 2020-03-19), which has been amended by several resolutions, most recently ARCSA-DE-2024-047-DASP (signed 2024-12-12, published in Registro Oficial 3er Suplemento No. 720 on 2025-01-13, in force from 2025-06-12).

2. Legal basis

Verification note: the gazette issue number, publication date and entry into force date of ARCSA-DE-2024-047-DASP are corroborated by the WTO notification of the draft resolution (G/TBT/N/ECU/504/Add.5) and by that resolution’s recital references to the preceding resolutions. The BPADT parent regulation 002-2020-LDCL is cited directly in the preamble (visto paragraphs) of the new regulation and rests on primary sources. Where a channel partner cites an older amendment as the basis of its certification, the discrepancy should be raised with the issuer before the partnership is activated.

3. Expert insights

Insight 1: BPADT is a channel obligation that runs in parallel with product obligations. Transitory general provision six of the new regulation establishes BPADT as a mandatory obligation at the establishment level. This means that even where a product already holds a registration certificate, if the establishment that stores or transports the product has no BPADT certification, the product cannot lawfully circulate. Product compliance and channel compliance are independent gates, and both must be open before goods move.

Insight 2: The new regulation amends the BPADT parent regulation in reverse through its reform provisions. Reform provisions one to four amend the definitions chapter and Article 6 of ARCSA-DE-002-2020-LDCL, including a new requirement that the technical director be a pharmaceutical chemist or a biochemical pharmaceutical chemist. This is institutional alignment between the product regulation and the channel regulation, and it means the two regimes can no longer be read in isolation from each other. An establishment that satisfied the old BPADT staffing expectations may now need to review its technical director appointment to remain compliant under the amended framework.

Insight 3: BPADT connects directly with domestic conditioning (acondicionamiento). Article 58 provides that an establishment performing only marking (marcaje) activities must hold a BPADT certification issued by ARCSA and have an approved marking area. This turns BPADT into a precondition for any domestic labeling scheme. Companies that intend to land products with English or Chinese labeling and re-label them for the Ecuadorian market must therefore solve the BPADT question before the first shipment, not after goods have arrived.

Insight 4: The BPADT framework has been amended frequently. After the 2020 parent regulation, amendments followed twice in 2021, once in 2023, once in 2024 and once in 2026, for a cumulative total of 5 amendments. When verifying the BPADT certificate of a channel partner, it must be confirmed that the certificate was issued under the latest version of the framework. A certificate issued under a superseded version may still appear formally valid on its face, while the establishment it describes no longer meets the current requirements, which is precisely the gap an inspector will find first.

Insight 5: BPADT, BPM and ISO 13485 form three parallel lines of good practices. BPM applies to manufacturing (Article 61), ISO 13485 applies to quality systems (Article 24(2.5) and Articles 62 and 63), and BPADT applies to storage, distribution and transport (transitory general provision six). The covered subjects and the issuing authorities differ across all three, and one certificate never substitutes for another. In practice this means an importer that holds an ISO 13485 registration for its quality system still needs BPADT certification for its warehouse, and a manufacturer with a BPM certificate still needs BPADT coverage for its outbound logistics.

4. Practical recommendations

1. Verify the BPADT certificate of every channel partner, and confirm that it was issued under the latest version of the BPADT regulation, requesting an updated certificate where doubt remains.
2. Record BPADT validity in the channel management ledger, with renewal reminders ahead of expiry.
3. Before launching a domestic labeling scheme, confirm whether the establishment has an approved marking area (Article 58).
4. Include a BPADT maintenance obligation in the holder agreement, with expiry constituting a breach, and attach the certificate as an annex so that the obligation can be verified without interpretation.
5. Keep the BPM, ISO 13485 and BPADT lines separate, and build a dedicated file for each.

5. Verification checklist

• □ Channel partners hold a valid BPADT certification
• □ The regulatory version underlying the BPADT certificate has been confirmed (after 2024-047-DASP)
• □ BPADT validity is recorded in the ledger with renewal reminders
• □ The domestic labeling establishment has an approved marking area
• □ The holder agreement contains a BPADT maintenance obligation
• □ Separate files exist for the BPM, ISO 13485 and BPADT lines

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, BPADT and channel certification verification, licensing structure design, official fee and timeline estimation, technical dossier preparation, and post-market compliance management. Manufacturers and importers qualifying storage, distribution or transport partners in Ecuador may contact GRZAN at info@grzanglobal.com for a tailored solution.