The client is an established developer and manufacturer of hematology, blood collection tubes and molecular diagnostic products in the USA and was willing to expand their business in Thailand. To gain market access into Thailand, the client was looking for a reliable Regulatory service partner for product registration and authorized representative services. Since the TFDA was reframing the classification guidelines, it was challenging to get the Regulatory approvals. However, after analyzing the client’s product in scope, Freyr framed a detailed Regulatory pathway and assisted the client with device classification, according to the new TFDA guidelines. Further, Freyr assisted the client compiling technical dossiers as per the TFDA requirements and provided LR support in the target markets.
How did Freyr overcome the challenges and provide end-to-end Regulatory services for medical device registration and LR support in Thailand? Decode the proven case study. Download.