In Ecuador, Medical Devices are regulated by the National Institute of Hygiene and Tropical Medicine (INHyMT) under the Ministry of Public Health. Some products must be registered with INHyMT before being marketed in Ecuador.  To register a medical or IVD device, the manufacturer must have an office or a local distributor in Ecuador registered with the Ministry of Public Health.

Our country specific (*) services in Ecuador include:

Medical Device specific regulation strategy reports, Medical Device Registration with INHyMT, Ecuadorian Representative and certification holder for Medical Device manufacturers, INHyMT 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 Ecuador!

(*) Ecuadorian 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.