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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.