The customer is an Australia-based manufacturer specializing in clinical and research solutions for a range of brain-related illnesses for predictive analytics. The customer approached Freyr for end-to-end Regulatory services to register their SaMDs in the Indian market and obtain an import license for their product, compliant with the new medical device rules. They were unaware of the SaMD device regulations and the CDSCO timeframes. In addition, the documents provided by the customer were not satisfactory, and it was challenging to process the SaMD registration with CDSCO.
How did Freyr overcome the challenges and provide end-to-end Regulatory services for SaMD registration in India? What were the customer benefits? Read through this proven case.