Venezuela Medical Device Regulation: The Mandatory COMEX Platform from 2025

1. Key takeaways

On 28 October 2025, SACS issued Circular N° DGSACS/0002/2025, effective the same day. The circular provides that SACS procedures and authorizations are to be handled through a new automated system operated jointly with the Foreign Trade Commission (COMEX). The scope covers all procedures in three streams: the Food Safety Directorate, the Directorate for Materials, Equipment and Sanitary Establishments, and the Directorate for Medicines, Drugs and Cosmetics.

The conclusion is that this is not a simple transfer from paper filing to online filing, but a reconstruction of the approval chain: COMEX acquires processing authority for legal regimes 3, 8 and 12, while SACS reviews and approves the documents. For projects already in progress, continuing to file through the old entry point carries a real risk of rejection, and the rejection may come late enough to consume the remaining validity of the underlying documents.

The operational reading is that two authorities now sit in sequence on every file, each with its own queue and its own notion of completeness. A file that satisfies SACS’s technical standards can still wait at the COMEX stage for a processing condition, and a file cleared by COMEX can still be refused at substantive review. Planning should therefore assume two sequential gates rather than one.

A practical corollary is that the representative’s competence now has to be assessed on two separate dimensions: knowledge of the technical standard and fluency with the platform. An entity that knows the standard well but operates the platform cautiously will still deliver a file, only more slowly. An entity that operates the platform fluently but understands the standard poorly will deliver a file that fails substantive review. Both failures cost the same calendar time.

2. Legal basis

3. Expert insights

Insight 1: the three instruments form a clear sequence, and together they constitute a single reform chain. Decreto N° 4.944 (April 2024) established the tariff and the legal regime column; Decreto N° 5.165 (30 September 2025) transferred processing authority over three legal regimes to COMEX; Circular DGSACS/0002/2025 (28 October 2025) connected SACS procedures to that platform. Only by reading the chain in order does it become clear why the platform migration is a reallocation of authority rather than a technical upgrade. Read in isolation, the circular looks like an IT notice. Read as the last link, it is the point at which the regulator’s discretion over file handling moved to a different ministry.

Insight 2: the circular took effect on the day of publication, with no transition period. Unlike Decreto N° 4.944, which allowed a 30-day legal window, Circular DGSACS/0002/2025 applies from the date of issue. Projects that were mid-submission around 28 October 2025 may therefore have had their procedural status altered without any notice to the applicant. The practical lesson is general: when a circular states that it takes effect on publication, the status of every open file should be re-confirmed rather than assumed.

Insight 3: the division of duties is explicit, with COMEX processing and SACS reviewing and approving. The circular states that COMEX handles applications under the three legal regimes, and that SACS reviews and approves all documents submitted for the purpose of obtaining permits and registrations. This is a front-office consolidation with a professional back office: the window is unified, but the review standard remains the SACS standard. Manufacturers should not read the unified window as a relaxation of technical requirements, and should not expect COMEX staff to resolve questions of device classification or clinical evidence.

Insight 4: the direct impact on projects already in progress. For files submitted at the SACS counter but not yet approved, whether the remaining steps must be re-done through the COMEX platform is a question that must be confirmed with the receiving authority after 28 October 2025. In practice the confirmation should be sought proactively rather than waited for, because no notice is issued file by file. A short written enquiry to the representative, with the file reference and the date of the last procedural act, usually produces a definitive answer within days and removes weeks of uncertainty from the schedule.

4. Practical recommendations

1. Route every new project through the COMEX platform and do not attempt submission at the old counter.
2. For projects in progress, ask the authorized representative to confirm the procedural status and whether resubmission or platform back-entry is required.
3. Because the platform is operated through accounts, the representative’s platform authority, as defined by the power of attorney, must match the type of procedure (article 23).
4. Keep a record of every platform action: archive the acknowledgement for each submission, correction and payment, so that procedural status can be evidenced at any point.
5. Re-confirm the applicable entry point at the start of each new file, since further circulars may adjust the scope of the platform.

5. Verification checklist

• □ The procedure applicable to this project is confirmed to fall within the mandatory COMEX platform scope (all three directorates covered)
• □ For projects in progress, procedural status has been verified and the need for resubmission or back-entry confirmed
• □ The representative’s platform authority matches the scope of the power of attorney
• □ An archive mechanism exists for submission, correction and payment acknowledgements
• □ The treatment of files straddling the effective date of Circular DGSACS/0002/2025 (28 October 2025) has been confirmed

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers, importers and authorized representatives with registration work in Venezuela, including COMEX platform filing, file-status recovery for projects caught by the 2025 migration, and platform authority design. Whether you need a status audit or hands-on filing support, our regulatory team can help. Contact us at info@grzanglobal.com.