CDSCO Mandates Risk Classification for Class A and B Medical Devices & IVDs
Recently, CDSCO has issued a notice reminding State Licensing Authorities (SLAs) that manufacturing licenses for Class A and B medical devices and IVDs must be issued only after verifying the device’s risk classification in the CDSCO’s official list. Notably, issuance...
CDSCO Regulations for Bone Marrow Cell Separator in India
India is witnessing a high prevalence of blood and bone marrow diseases, such as aplastic anaemia, leukaemia, and multiple myeloma. Bone marrow cell separator is a standard laboratory medical device used to diagnose and monitor these diseases. The treatment and...