The customer is a China-based MedTech company with a huge portfolio of medical devices and IVD products. The products were manufactured at different places located in China and have already gained registration approval in China and the European Union (EU). Currently, the customer requires product registration in Mexico and is not familiar with the Regulatory landscape of Mexico, specifically related to COFEPRIS. Therefore, the customer approached Freyr for assistance with end-to-end device registration services, Mexican Registration Holder (MRH) service, and translation support.
How did Freyr provide the right Regulatory approach leading to cost optimization for device registration in Mexico? What were the customer benefits? Read through this proven case.