Venezuela SACS Directorates: Two Separate Device and Drug Tracks

1. Key takeaways

Within SACS, health products are managed by directorate according to broad product family. Medical devices, materials, equipment, health establishments and health professions belong to the Directorate for the Regulation and Control of Materials, Equipment, Establishments and Health Professions; medicines, drugs and cosmetics belong to the Directorate for the Regulation and Control of Medicines, Drugs and Cosmetics. The former is divided into 4 departments and the latter into 6.

The conclusion is that choosing the wrong directorate is not a formal defect that can be corrected afterwards. Since the COMEX platform became mandatory in 2025, the choice of directorate determines which form and which approval chain apply on the platform. A filing submitted to the wrong one is returned, and neither the timing of the return nor the time already spent is within the applicant’s control.

The reason this deserves attention at the very beginning of a project is that the choice is invisible in the product documentation. Nothing in a technical file states which directorate should receive it; the answer comes from the product family, the intended use and, for borderline products, from a written confirmation. That confirmation is a cheap document to obtain and an expensive one to omit.

The two-track arrangement also has a commercial reading. Because the device channel and the medicine channel are staffed, scheduled and reviewed separately, progress in one says nothing about progress in the other. A manufacturer that also holds medicine registrations in Venezuela may find that its device file is untouched while its medicine file is being actively reviewed, and the reverse. Reporting that merges the two into a single regulatory status indicator conceals exactly the information a management decision needs.

2. Legal basis

3. Expert insights

Insight 1: Circular DGSACS/0002/2025 explicitly names three affected directions, namely the food safety directorate, the materials, equipment, establishments and health professions directorate, and the medicines, drugs and cosmetics directorate. That enumeration shows the platform migration is not a pilot in one unit but a change covering every directorate. Every submission made on the platform must therefore first be routed to the correct directorate direction, and a submission that is technically complete can still be procedurally misplaced.

Insight 2: the materials, equipment, establishments and health professions directorate contains 4 further departments, and health materials and equipment is the one where devices land. The three-level structure of directorate, department and matter means that confirmation must reach the third level before filing. The most common error in practice is to stop at the directorate level and assume the rest will be routed internally.

Insight 3: for combination and borderline products, the channel must be anticipated rather than discovered. Drug-device combinations, device-drug combinations and some in vitro diagnostic products may fall across the two channels. Such products should be confirmed with SACS through the authorized representative before filing, rather than classified by the manufacturer on its own judgment, because the manufacturer has no standing to make the determination binding.

The three insights describe one chain of risk. A wrong directorate produces a wrong form, a wrong form produces a return, and a return produces a delay that is invisible in the project plan until it happens. Mapping the chain in advance converts an unpredictable event into a documented decision taken before any document is prepared.

The mapping should also record the counterpart, not only the unit. A four-level map that names a directorate, a department, a form and a matter type but does not name a contact or a filing account is a diagram rather than an operating tool. In practice the two pieces of information that most often unblock a stuck file are the name of the person who can confirm routing and the platform account under which the submission was lodged, and both belong on the same page as the mapping.

Finally, the platform dimension should not be underestimated. When a procedure moves onto a shared platform, the organizational chart and the form structure stop being two separate descriptions of the same thing and become one. A change of directorate is then visible as a change of form, and a change of department as a change of approval chain. Reading the platform structure is therefore a legitimate way of reading the organization, and it is often faster than any other.

4. Practical recommendations

1. Build a four-level mapping of product to directorate, department, platform form and matter type. Keep one map per active project and file it with the project record.
2. For borderline products, always obtain prior confirmation, and begin preparing documentation only after the confirmation has been recorded in writing.
3. Where one manufacturer has several products falling under different directorates, prepare separate volumes by directorate and do not combine them into a single submission.
4. The authorized representative must have practical experience with the relevant directorate. This is a specific selection criterion when appointing a representative, not a general claim of having experience.

5. Verification checklist

• □ Confirmed the four-level mapping for this product: directorate, department, platform form and matter type
• □ Obtained written confirmation of the channel for combination products from SACS or the authorized representative
• □ Divided multi-product projects into separate volumes by directorate, with no cross-directorate consolidation
• □ Verified that the authorized representative has actual filing experience with the relevant directorate
• □ Filed the four-level mapping in the project record with the verification date noted

Regulatory information verified as of October 29, 2026.

For a Venezuela market-entry feasibility assessment covering your specific product, contact the GRZAN regulatory team. GRZAN supports manufacturers, importers and authorized representatives with device registration in Venezuela: mapping products to the correct directorate and department, obtaining channel confirmations for combination products, and preparing submissions on the correct platform form from the outset. Reach us at info@grzanglobal.com.