A South Korea-based global manufacturer of biomedical devices, surgical devices and medical implants in the field of Aesthetics was aiming to expand their products in the ASEAN region. As the client was new to the target market, they approached Freyr for device classification, registration and local representation services. It was challenging for the client to navigate the ASEAN markets, as they had unique Regulatory requirements, the devices in scope were of high-risk and the detailed technical dossiers were to be submitted in both Thai and English. However, Freyr ensured to provide clear and elucidated solutions for the Thai FDA registration in a cost-effective manner.
Read through this case study to understand how Freyr overcame the challenges and provided end-to-end registration services for high-risk devices. Download.