A China-based manufacturer of blood purification devices approached Freyr to provide end-to-end Regulatory support to launch their devices in Thailand. The client required an independent Market Authorization Holder (MAH) and the certified true copy of ISO 13485:2016 from the local Notified Body that is based in Thailand. In addition, owing to language barriers, client had difficulties in communicating with the Thai Food and Drug Administration (TFDA).
Discover how the client experienced a hassle-free device registration process with Regulatory assistance from Freyr. Download the proven case.