Last Fall, the Indian CDSCO said that high risk Class C and D medical devices could not be sold without an import/manufacturing license after September 30. Risky Class C and D products included – surgical robotic devices, linear accelerators, imaging equipment, etc. Then, in an effort to facilitate this required transition, the CDSCO also stated that importers and manufacturers’ registrations could be extended by 6 months or until the CDSCO made a decision on their applications if they submitted their applications prior to September 30, 2023. Six months ended at the end of March. However, since some risky device manufacturers/importers were not able to get their new licenses by then, on May 16, 2024, the CDSCO again extended the time period another 3 months to give these applications more time. In short, many of these companies were waiting for the CDSCO audits to fulfil requirements that had not happened yet.
In addition, also in May, the CDSCO has reiterated the need for better post-market surveillance. Accordingly, the Drugs Controller of India (DCGI) has said the device manufacturers and device license holders should notify the Indian government’s Materiovigilance Program of India (MvPI) platform of any adverse events focusing especially on adverse events from life saving devices. The Indian Pharmacopoeia Commission overseas the MvPI. Timely reporting of adverse events will help the Indian government determine the safety and efficacy of devices, help to implement appropriate responses in a timely way, and improve the overall health of the Indian population.
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.