CCAA Storage Permit for Colombian Importers Under Resolución 4002
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
Importers must hold a valid CCAA (Certificado de Capacidad de Almacenamiento y Acondicionamiento), a precondition set jointly by Decreto 4725 de 2005 and Resolución 4002 de 2007. Without a CCAA, even a complete registration cannot be landed through import – it is the importer’s first ticket, and it expires earlier than the registration: a CCAA is valid for 5 years, while a device registration certificate is valid for 10 years.
GRZAN’s recommendation is to manage the CCAA like a perishable good. Resolución 4002 de 2007 requires the importer to employ a technical director (director técnico) and to apply for re-inspection at least 5 business days before expiry (public INVIMA guidance). 5 business days is a very short buffer; once the slot is missed, every import batch during the certificate gap sits without valid qualification.
Because the CCAA sits upstream of every import batch, its renewal should be managed with the same discipline as the registration itself: the expiry date is entered in the compliance calendar on day one, ownership of the renewal task is assigned to a named person, and the premises evidence is refreshed ahead of the re-inspection window so the application can be filed without scrambling for documents.
2. Legal basis
| Regulation | Number | Publication date | Provision |
|---|---|---|---|
| Resolución 4002 de 2007 (manual of storage and conditioning capacity requirements) | Resolución 4002 de 2007 | 2007 | Requirements for obtaining and maintaining the CCAA; technical director (director técnico) |
| Decreto 4725 de 2005 (medical device registration and vigilance system) | Decreto 4725 de 2005 | December 26, 2005 | Art. 3 (definition of importador) |
| Decreto 4725 de 2005 (medical device registration and vigilance system) | Decreto 4725 de 2005 | December 26, 2005 | Art. 19 (legal documentation list) |
| Decreto 582 de 2017 (amends 4725/2005) | Decreto 582 de 2017 | April 4, 2017 | Post-grant verification, suspension and cancellation rules |
| Resolución 1405 de 2022 (semantic standards and UDI-DI) | Resolución 1405 de 2022 | August 8, 2022 | Special storage/packaging conditions field among the regulatory attributes |
| Resolución 4816 de 2008 (national device vigilance program) | Resolución 4816 de 2008 | 2008 | 72-hour reporting of serious adverse events; recalls executed per INVIMA instructions |
| Ley 9 de 1979 (health code) | Ley 9 de 1979 | 1979 | Foundation of health regulation (general reference) |
3. Expert insights
#### The CCAA governs what happens after the goods arrive, not whether they can enter
Many companies treat the CCAA as a customs document, but it actually governs storage and conditioning (acondicionamiento) capability: temperature and humidity conditions, zoned storage, traceability records, and segregation of nonconforming products. Resolución 1405 de 2022 lists special storage/packaging conditions among the regulatory attributes, meaning storage conditions have entered the structured data layer and are bound to the UDI-DI records. A mismatch between the warehouse’s actual conditions and the declared conditions is one of the most frequent findings in verification.
#### The 5-year validity should be scheduled like a shelf life, not handled at expiry
Device registration certificates run 10 years and the CCAA runs 5 years; the two are out of sync. An importer operating for ten years will inevitably face at least one CCAA re-inspection, and the application window is only the 5 business days before expiry (public INVIMA guidance). GRZAN’s practice is to write the re-inspection date into the calendar on the day the certificate takes effect and to prepare the site conditions 3 months in advance (practical estimate).
#### Multiple importers cannot share one CCAA
A CCAA is issued to a specific entity for specific premises. Multiple importers within a group, or multi-warehouse operations, require separate certificates or an extended coverage scope. Because the Colombian market depends on imports for roughly 80%–85% of its supply, logistics are often handled by third-party warehousing; if the third-party premises are not covered by the CCAA, the liability still rests with the certified importer.
#### The technical director is a substantive requirement of the capability certificate
Resolución 4002 de 2007 requires an employed director técnico. This role is not nominal: during verification, inspectors will ask about storage-condition determinations, handling of nonconforming products, and the interface with vigilance reporting. Read together with the 72-hour serious adverse event reporting and quarterly periodic reports of Resolución 4816 de 2008, the technical director is the hub of the importer’s compliance chain.
4. Practical recommendations
- Importer lead: confirm the effective and expiry dates of your CCAA and set a hard calendar reminder for the re-inspection application 5 business days before expiry.
- GRZAN regulatory team: check whether the premises covered by the CCAA include every warehouse actually in use, including third-party warehouses.
- Importer HR: employ a qualified director técnico and retain the appointment documents and proof of employment.
- Warehouse management: maintain temperature and humidity records, zoning and nonconforming-product segregation per the CCAA declaration, keeping traceable records.
- Manufacturer: stipulate in the agreement with the importer an obligation to maintain the CCAA, and the liability and remedies during any gap.
- Quality department: align the storage conditions covered by the CCAA with those declared in the semantic report under Resolución 1405 de 2022.
5. Verification checklist
- □ The importer holds a valid CCAA within its 5-year validity
- □ CCAA-covered premises include all warehouses actually in use (including third-party warehouses)
- □ The director técnico has been appointed with complete appointment documents
- □ The re-inspection application is scheduled for 5 business days before expiry
- □ Warehouse temperature, humidity and zoning records can be retrieved at any time
- □ The storage conditions declared in the CCAA match the storage condition fields in the semantic report
- □ The agreement with the importer covers the CCAA maintenance obligation and gap-period liability
- □ The vigilance reporting chain (72 hours) is connected to the technical director’s duties
- GRZAN regulatory team
Regulatory information verified as of October 29, 2026
All conclusions published here are based on the current regulatory texts issued by the competent authority and are verified item by item before delivery.
GRZAN supports manufacturers and importers in the Colombian market with CCAA strategy, director técnico arrangements, storage-compliance reviews, and complete fee budgeting for registration and maintenance, including local licensed-entity and importer services. To keep your import qualification from lapsing unnoticed, contact us at info@grzanglobal.com.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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