Emergency Authorisation

Official source: CDSCO; AYUSH Ministry

Emergency authorisation allows CDSCO to grant rapid access to medical devices needed to address urgent public health emergencies or critical patient situations. The specific conditions, application process, and evidence requirements for emergency authorisation under Indian regulations should be detailed. Applicants typically must demonstrate that no licensed alternative exists, the emergency creates a compelling need, and the device has evidence of safety and efficacy from overseas regulatory approvals or clinical data.