The client was a small-scale manufacturer from India and had a portfolio of innovative products indicated in infection control and prevention. With a vision to expand into the ASEAN, GCC, North America, South America, EU and African markets, the client required Freyr’s services for multi-country device registration, in-country representation (for specific markets) and other Regulatory activities that are necessary for market entry. In addition, the client wanted Freyr to support for TFDA interactions to get approval for the device license. Given the multiple markets in scope and the product being a borderline product, it was challenging to execute the project as per the client’s business priorities and country-specific requirements.
How did Freyr overcome the challenges and provide end-to-end Regulatory services for notification of a medical device in Thailand? What were the client benefits? Read through this proven case. Download.