In Venezuela, Medical Devices are regulated by the Ministry of Popular Power for Health (MPPS). All products must be registered with MPPS before being marketed in Venezuela. A risk-based classification system has not been established, however, devices are classified according to categories of use. To register a medical or IVD device, the manufacturer must have an office or a local distributor in Venezuela registered with MPPS.

Our country specific (*) services in Venezuela include:

Medical Device specific regulation strategy reports, Medical Device Registration with the MPPS, Venezuelan Representative and certification holder for Medical Device manufacturers, Technical dossier Preparation and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Venezuela!

(*) Venezuelan Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.