All Indian Medical Devices Soon to be Fully Regulated

Recently, India Central Drugs Standard Control Organization (CDSCO) announced that all Class C and Class D non-notified medical devices will need a comprehensive license by October 1st, 2023. In 2020, the Indian Ministry of Health and Family Welfare outlined its definition of medical devices, including non-notified medical devices. Today, non-notified Class C and Class D devices do not require an import/manufacturing license to enter India. However, in October, that will change. Please keep in mind that getting a medical device license into India can take up to 9 months including dossier preparation. Thus, applicants must proceed quickly to meet the deadline.