The manufacturing industry for MedTech and Hi-Tech products is an evolving sector that must comply with ever-changing regulations in the MEA region. In order to bring products into UAE, Saudi Arabia or Egypt, manufacturers must comply with authorities and regulators such as MOH, SFDA, EDA, TRA, FANR, SABER, NTRA and others.
Effective spare parts management is crucial for manufacturers that provide high-value equipment to customers. When problems arise, customers expect quick and efficient resolution, and manufacturers must have a solid strategy in place to ensure a timely supply of spare parts.
When your company plans to import goods into a new country, you'll soon discover you must have a local legal entity or an appointed agent there. This is when an independent importer of record (IOR) can help.
If your business accepts high-value equipment and spare parts imported into the MEA region, you are fully aware it’s a complex and time-consuming process.
The Middle East and Africa market for medical devices is growing exponentially year on year since 2014, and this expansion is expected to continue at 5%, or more, in the coming years.
Many MEA countries including UAE impose a variety of fines and penalties for non-compliance of trade regulations which can be in hundreds of thousands of dollars for the most severe breaches such as safety violations.
