Overall, health indicators in Sudan are poor, but in North Sudan these are better than most Sub-Saharan African countries. The regulations of pharmaceuticals and medical devices are carried by the National Medicines and Poisons Board (NMPB), through the Directorate General of Medical Devices Assessment and the Committee of Medical Device registration.

The authorities approve all classification systems, but the committee will decide the official classification in which the product will be registered. The application must be submitted by a local representative and include GMP certificate, CFS and other documents.

Our country specific (*) regulatory services in Sudan include:

Medical Device specific regulation strategy reports in Sudan, Medical Device Registration NMPB and the Committee of Medical Device Registration, technical documents preparation, license holder and local Authorized Representative in Sudan, QSD registration 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, submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Sudan!

(*) Sudanese 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.