Venezuela SIACv2 and COMEX 2026: Platform Integration and Filing Practice

1. Key takeaways

SACS is advancing its digital platform build-out. Its automated sanitary control information system (SIAC) has been iterated to SIACv2 and is accessible through the institutional website, supporting procedures such as health establishment permits and electronic free sale certificates for medicines, together with status queries, document uploads and fee payment. From October 28, 2025, SACS procedures are additionally handled jointly with the COMEX platform.

The conclusion is this: the direction of platform evolution is the integration of data across the customs, health and foreign trade ends. For companies this means that compliance data, once generated, circulates between several systems, so a single error is identified at all three ends at once, and a single improvement is also shared across all three. The upside is real, but it accrues only to files whose data is already accurate before submission.

There is a less obvious consequence for project management. In a paper-based environment, an inconsistency between the certificate and the customs declaration could persist unnoticed for years because no process compared them. Once the systems exchange data, comparison is automatic and continuous, which converts a dormant administrative imperfection into an active clearance failure.

2. Legal basis

Position statement: the functional scope and launch timing of SIACv2 derive from 2025 industry media reporting and are marked as a practical estimate; its feature list may change as versions iterate.

The legal architecture behind the platform is worth separating from the platform itself. Decreto N° 5.165 assigns the handling of legal regimes 3, 8 and 12 to COMEX, Circular DGSACS/0002/2025 places the procedure on a joint automated system, and Decreto N° 4.944 supplies the tariff codes to which those legal regimes are attached. The platform is therefore the visible surface of an allocation of authority that was made in the decrees, not a technical project with its own logic.

3. Expert insights

1. The two platforms perform different functions and must be distinguished. SIACv2 is SACS’s own business system, handling matters within SACS competence, status queries, document uploads and payment. COMEX is the cross-departmental platform of the foreign trade commission, handling applications under legal regimes 3, 8 and 12. What Circular DGSACS/0002/2025 establishes is that procedures run through COMEX while SACS retains review and approval. The relationship is collaborative, not substitutive. A submission made on the wrong platform is not merely misrouted; it may not exist for the authority that has to act on it.

2. The 10-digit HS code is the technical foundation of data integration. Because column 5 of the tariff schedule attaches the legal regime to the tariff code, that code becomes the primary key shared by the health end, the customs end and the foreign trade end. This explains why classification accuracy matters more in Venezuela than in most markets: it is the precondition for the three ends to link the same data correctly. A classification error propagates as a mismatch between a certificate, a permit and a declaration that were each individually correct.

The same primary key explains why an amendment to a single field has consequences beyond the transaction in which it was made. Correcting a model designation in one system without correcting it in the others leaves the three ends describing two products, and the discrepancy is attributed to the applicant rather than to the platform. This is the practical argument for treating master data as a controlled document with a named owner, version history and a change procedure, in the same way as a certificate.

3. Platformization raises the probability that consistency errors surface. In the paper era, a discrepancy between the information on a certificate and the information on a customs declaration might never be discovered. With the systems connected, such discrepancies are compared automatically. This increases risk and creates opportunity in equal measure: projects with accurate data benefit from accelerated processing. The distribution of outcomes widens, which means data quality becomes a competitive variable rather than a housekeeping matter.

4. Platform evolution imposes new requirements on document preparation. The systems require structured data rather than free text. Key fields such as product name, model and manufacturer information must match the certificate and the label exactly at the point of entry. The recommended control is a system entry field list, checked item by item against the certificate, the label and the technical file before submission. Building that list once and reusing it for each submission is cheaper than correcting a mismatch after the consignment is flagged.

4. Practical recommendations

1. Regulatory affairs leads: distinguish the functions of SIACv2 and COMEX, confirm the applicable entry point for each project, and do not assume the two are interchangeable.
2. Regulatory operations: build a system entry field list and check it item by item against the certificate, label and technical file before each submission.
3. Importers: retain evidence of every platform transaction (submission, correction request, payment) as proof of the procedural status.
4. Regulatory affairs leads: track platform version iterations, since functional changes can affect how operations are performed and the SIACv2 feature list may be updated with each version.
5. Trade compliance teams: treat classification accuracy as the first gate of data quality and validate it before entry rather than after.

5. Verification checklist

• □ The functions of SIACv2 and COMEX are distinguished and the applicable entry point is confirmed
• □ A system entry field list exists and the consistency check has been completed
• □ An archiving mechanism for platform transaction evidence is in place
• □ A mechanism for tracking platform version iterations is configured
• □ Classification accuracy is validated before data entry

Regulatory information verified as of October 29, 2026

All conclusions published here defer to the current regulatory texts as issued by the competent authority, verified item by item before delivery.

— GRZAN Regulatory Team

GRZAN supports medical device and IVD manufacturers, importers and authorized representatives with registration and post-market compliance in Venezuela: dossier preparation and filing through the SACS and COMEX channels, license-holder coordination, technovigilance and adverse event workflows, recall and field corrective action planning, inspection readiness, and continuous monitoring of circulares and decrees. For tailored support on your Venezuela portfolio, contact the GRZAN regulatory team at info@grzanglobal.com.