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Venezuela Medical Device Registration

Venezuela Medical Device Regulation

Regulatory Authority:

  • ServicioAutonomo de Contraloria Sanitaria (SACS)

In 1994, the creation of the Sector General Directorate of Sanitary Comptroller was mandated through Presidential Decree No. 472, issued on 12/27/1994. This entity was tasked with overseeing the registration, supervision, and inspection of drugs, cosmetics, food and beverages, equipment, buildings, and health professions. Agreements were established with state governors to facilitate the administration of procedural matters and sanctions in this domain. Consequently, the Divisions were reorganized into Directorates, namely the Directorate of Drugs and Cosmetics and the Directorate of Food Hygiene.

  • Formerly the Office of Registration and Control for Medical and Paramedical Equipment and Supplies – Medical Devices and IVDDs must be registered with the OICEMP

Link for Regulatory Authority: http://www.sacs.gob.ve/site/

Local Regulation:

Classification:

  • Class I
  • Class II
  • Class III
  • Class IV

Listing or Registration Requirements:

Documents Required for Registration:

  • Application Form
  • STED Product Dossier
  • Essential Principles of Safety and Performance
  • Labelling & packaging
  • Quality documentation

Registration Timeline:

New Registration:

  • 20 working days (official timeline)
  • 40 working days (based on experience)

License Validity: 5 years

Special Labelling Requirements:Documentation and labelling must be submitted in Spanish.

Who should make this communication:

  • Manufacturer
  • Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

  • Act as your Authorized representative

Why Choose Us

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]

 

 

 

 

 

 

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