Venezuela medical device regulations

Selected medical-material and equipment rows 3–5, the complete table headings, common reference-value note, printed template code and re-inspection note are retained from the one-page customs fee guide. Independent food-only rows 1–2 are excluded from typed publication. Petro amounts are transcribed as printed reference values; neither current payable amounts nor a 2026 conversion basis is asserted. The August 2022 footer is a template identifier, not a proved commencement date.

The signed 18 September 2026 SACS circular sets documentary and physical verification steps for sanitary release slips. Medical-device relevance is limited to the release workflow evidenced by Providencia 008-2019 and the medical-device checklist. The source addresses exporters and customs agents while referring to entry or dispatch; that wording is preserved. Its 24-hour clause starts after receipt of a conforming application and is not described as an overall device import or registration approval deadline. Later amendments and formal commencement remain unverified.

SACS establishes a common sanitary customs sanction procedure for importers. The medical-device bridge is the release checklist that expressly names both this instrument and Providencia 008-2019, whose Article 2 explicitly covers medical materials and equipment. The 2% commercial-invoice provision is a conditional sanction, not a registration fee. Signature and publication-dependent commencement remain distinct; no wholesale repeal of 008-2019 or later-currentness conclusion is inferred.

Complete two-page SACS customs checklist and receipt fields explicitly include the medical materials/equipment directorate and cite Providencias 008-2019 and 069-2019. All fourteen requirement rows, twenty-eight empty verification boxes, blank fields and the continuation across pages are retained. Requirements remain conditional on cargo type and the source wording; this is neither a new product-registration form nor proof of the currently payable fee. The upload date is not treated as a legal issue date.

Signed SACS customs procedure expressly includes medical materials and equipment in Article 2. It covers sanitary release slips, responsible customs officers, payment references and sanctions, rather than granting product registration. Article 9 names only Providencia 298-2018 for repeal. The signed 18 January 2019 date and publication-dependent commencement are retained without assigning an unproved publication or effective date. Later amendments and current fees remain unverified.

Selected MD-only central fee guide: exclusions/imports; risk-based product registration/renewal; export and product changes; enterprises/inspections/GMP. The undated body supplies no signed instrument number, publication or commencement. February2020 appears in the filename only. It is not the missing signed030/2020 original. Distinct from the2022 central guide: p6 row6 is company-address change0.85Petro, not manufacturer inclusion. Relationship to030/2020,006/2022 and later fees remains unverified. Non-device clinical/professional, biological-sample and hygiene rows excluded.

Blank SACS import-permit application for health materials/equipment, with purpose choices for registration samples, research, teaching, natural persons and the printed DONACIÓN PROFESIONALES option. Captures evaluating institution, sample and patient counts, entry port and a three-clause sponsor declaration including manufacturing practices; this is not standalone clinical/performance-study authorization. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS export-permit application explicitly titled for natural persons, capturing product quantities, manufacturer/country and departure/entry ports. The form retains company-authorized applicant and sponsor wording despite the natural-person title; its one-clause sworn declaration differs from company export form05. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS company export-permit application capturing holder/company registration, sponsor, exported product PMP and quantities, national manufacturer and departure/entry ports. Source page1 sectionE heading overlaps footer graphics; unchanged page images must accompany the transcription. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS commercial-denomination-change application capturing registered product PMP, previous/current product name, brand, presentation, use, holder, sponsor and manufacturer. It is a product-name procedure, distinct from changes of manufacturer/owner legal name. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS primary-packaging-change application whose table contrasts approved and proposed primary-packaging materials and retains secondary-packaging yes/no and description fields. It is distinct from the secondary-packaging procedure and does not itself contain the supporting evidence checklist. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS manufacturer-change application titled for national or imported health materials/equipment, with product PMP and manufacturer blocks labelled ACTUAL and A CAMBIAR. Both address blocks retain foreign-company headings; this template wording does not itself narrow the national/imported title. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS manufacturer-address-change application expressly titled for imported health materials/equipment, with previous/current addresses, product class including DIAGNÓSTICO and usage restrictions. A retained NACIONAL checkbox does not independently extend the title-specific scope, and this is not an establishment-address-change application. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS manufacturer-legal-name-change application expressly titled for imported health materials/equipment, retaining previous/current manufacturer identity, company registration and address blocks. Generic national-origin choices are retained as source wording and do not prove wider applicability. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS imported-device manufacturer-inclusion application identifying the manufacturing plant to add and the holder, sponsor, importer, distributor and optional packer. It is distinct from the national-manufacturer inclusion form29; retained generic origin choices do not extend the imported-product title. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS manufacturer-exclusion application identifying the registered product and manufacturer to remove, with holder, sponsor and declaration fields. Excluding a manufacturer from a product record is distinct from canceling product registration or an establishment authorization. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS product-owner-change application with separate holder, manufacturer and previous/current product-owner identity blocks. Product ownership transfer remains distinct from registered-holder transfer and from owner-legal-name change. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS product-owner legal-name-change application with separate holder, manufacturer and previous/current owner blocks. The similarly structured product-owner transfer form15 is a separately titled procedure and is not merged into this template. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS formula-change application limited by its title to no substitution of the active principle and no effect on the material's intended use. It captures product class/restrictions and company/sponsor identities but has no explicit previous/proposed formula comparison fields; it is not a general pharmaceutical or unrestricted composition-change route. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS label-change application capturing product PMP, holder, sponsor and manufacturer identities. It has no explicit previous/proposed label-description field; label evidence and the separately reviewed1905 context remain separate from this application template. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS notification-of-destruction application for deteriorated or expired health materials/equipment, with a product table for name, PMP, manufacturer, manufacture/expiry dates and quantity. It has no separate lot/batch or destruction date/method field and is distinct from market withdrawal. Printed footer literally reads F.19-MEEPS-MES-OPP-JULIO3022 with a space before3022; the source spelling is preserved. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS commercial-presentation inclusion application with the product PMP, presentation A INCLUIR, holder, sponsor, manufacturer and importer. Addition of a commercial presentation is distinct from changing primary or secondary packaging materials. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS commercial-presentation exclusion application with separate presentation and presentation A EXCLUIR fields plus holder, sponsor, manufacturer and importer. Removing a presentation does not itself cancel the full product registration. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS product-level importer/distributor inclusion application with product PMP, current holder and company-to-include EMP/RIF/contact fields. Its sponsor section expressly concerns the company being included; it is not first establishment registration. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.

Blank SACS product-level importer/distributor exclusion application with product PMP and company-to-exclude identity fields. The title says Y while the company block says Y/O; both are retained, as are the source's duplicate field11 labels for manufacturer country and holder RIF. This is the blank application template; the separately paired requirements checklist defines supporting-document demands and is not replaced by these fields. Footer JULIO wording is template evidence only; legal currentness and later replacements remain unverified.