Venezuela Medical Device Regulators: MPPS, SACS and INHRR Compared

1. Key takeaways

Medical device oversight in Venezuela is shared by three institutions, and the relationship among them is not a chain of command but a horizontal division of labor: the Ministry of the People’s Power for Health (MPPS) is the competent authority, the Autonomous Sanitary Supervision Service (SACS) exercises administrative approval and inspection powers, and the Rafael Rangel National Institute of Hygiene (INHRR) carries out technical testing and quality evaluation.

For manufacturers outside Venezuela the most consequential conclusion is this: only SACS receives and decides registration applications, and INHRR does not issue registration certificates. Treating the technical testing body as if it were the approving authority misdirects the addressee of the filing and, from that point onward, distorts the entire preparation of the dossier. Foreign manufacturers do not deal with any of the three institutions directly, because the legally designated applicant is an authorized representative resident in Venezuela.

The three bodies also differ in where their authority comes from, and that difference explains why the practical requirements move faster than the law does. The MPPS draws its powers from a statute and an organizational regulation; SACS draws its powers from the organizational regulation and ministerial resolutions; INHRR draws its powers from the regulation that created it. Because the two institutions that actually touch files operate below the statutory level, their working rules can be changed by a circular signed by a director general, without any amendment to the law. Reading only the statute therefore tells a manufacturer almost nothing about what a submission must contain.

2. Legal basis

3. Expert insights

Insight 1: the three institutions draw authority from different sources, and the stability of that authority differs accordingly. The competences of the MPPS come from the law and the organizational regulation, which sit at the highest level but state principles rather than procedures. The competences of SACS come from the organizational regulation and ministerial resolutions, which is the level at which files are actually handled. The competences of INHRR come from its own creation regulation and stop at technical evaluation. This is why changes in Venezuelan approval practice almost always appear first in a SACS circular rather than in the text of a law, and why a monitoring routine built around statutory amendments will systematically miss them.

Insight 2: SACS itself applies a second division of labor internally. Below SACS sits the Directorate for the Regulation and Control of Materials, Equipment, Establishments and Health Professions, which is in turn split into 4 departments: health establishments, health professions, health materials and equipment, and inspection and technical vigilance. Medical devices fall under the health materials and equipment department, while medicines and cosmetics run through a different channel. The institution therefore has a single name but several intake windows, and a filing sent to the wrong window is returned at the admissibility stage, before any technical review begins.

Insight 3: the existence of inspection and technical vigilance as a permanent internal department shows that post-market control is a mandatory regime rather than a voluntary commitment. A department with inspection in its title is not a customer service function; it is the organizational expression of a legal duty that continues after the certificate has been granted. The scope of that duty, and the reporting obligations attached to it, are set out in Articles 43 and 44.

4. Practical recommendations

1. The first task when a project opens is to confirm the intake window, not to draft technical documents. Confirmation has three layers: which directorate of SACS, which department within that directorate, and which corresponding entry point on the COMEX platform.
2. Interaction with INHRR should be framed as cooperation on testing and evaluation, including any mandatory local testing, and never as an approval conversation. Requests for approval sent to a laboratory are simply redirected, and the round trip costs weeks.
3. The authorized representative must be appointed before any technical work begins, because the applicant, the account holder on the platform and the party carrying subsequent liability are the same legal entity.
4. Maintain a tracking routine for personnel changes inside the institutions. The appointment and removal of the SACS director general is effected by a resolution published in the Official Gazette, as happened with the appointment resolution published on December 17, 2024, and such changes are frequently followed by adjustments in how intake is handled.

5. Verification checklist

• □ Confirmed that the product belongs to the health materials and equipment channel rather than the medicines or cosmetics channel
• □ Confirmed that the current name of the SACS intake department has not changed following an amendment to the organizational regulation
• □ Confirmed whether the procedure for this project falls within the mandatory scope of the COMEX platform (from October 28, 2025)
• □ Confirmed that the qualifying documents of the authorized representative are complete and that the entity can act as applicant
• □ Re-checked whether Gaceta Oficial N° 38.591 has been replaced by a later version of the organizational regulation

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 the product to the correct SACS directorate and department, confirming the COMEX platform entry point, coordinating testing with INHRR, and preparing submissions that survive admissibility review. Reach us at info@grzanglobal.com.