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.

Emergency authorisation applications should be submitted to CDSCO through the SUGAM portal (sugam.cdsco.gov.in) or directly to the DCGI's office. Required documentation typically includes: (1) completed application form; (2) detailed description of the emergency situation and public health necessity; (3) proof that no licensed alternative exists in India; (4) overseas regulatory approval documentation or clinical evidence of safety and efficacy; (5) ethics committee approval or waiver; (6) manufacturer's letter of support; (7) device specifications and available safety data. Given the emergency nature, CDSCO may expedite review and approval decisions, with timelines potentially compressed to days or weeks depending on the severity of the situation and completeness of submission.