A Canada-based manufacturer and supplier of respiratory medical devices wanted to launch their Positive Expiratory Pressure Therapy System and Breath Actuated Nebulizer in the Indian market. The client approached Freyr seeking Regulatory services for device registration with the CDSCO and Indian Authorized Agent Services. Though the devices under scope were classified as Class II devices with the US FDA, they had to be re-classified, as per the CDSCO’s Medical Device Regulations. Further, it was challenging to get the CDSCO approval for the nebulizer, as it was not regulated in India when the client approached Freyr and the CDSCO’s Regulatory proceedings usually take 6-9 months’ time.
How did Freyr assist the client with end-to-end device registration services? Read through this proven case study to understand Freyr’s strategic approach.