A U.S. based leading provider of uterine cannula and contraceptives approached Freyr for assistance with the classification of category of its medical device in India. As the client was not familiar with the regulations and requirements of the CDSCO, it was a challenge to identify if the device was regulated by the Agency or not.

Through this case study, decode how Freyr leveraged its Regulatory knowledge to identify the classification of the device as per the regulations of CDSCO and timely compiled and submitted the technical dossier to the Agency.