In 2020, India promulgated their Medical Device Rules Act. This act increased medical device registration requirements in India. Before the act, only about 35 device categories required registration. After the act, all previous non-regulated devices now need CDSCO approval. Initially, non-regulated Class A and B devices were required to be registered by October 1, 2022. This has now been changed to March 31, 2023. Class C and D non-regulated devices must now be registered by October 1, 2023. Since registering Class C and Class D devices usually takes about 4-6 months, foreign manufacturers must start this process now to meet this deadline.
Generally, for Class A and B licenses, technical files and quality system documentation are reviewed by Notified Bodies. Higher-risk medical devices are reviewed by the CDSCO. Like most markets, it is easier to register medical devices with predicates than devices without predicates. If there are no predicates, more clinical data will be needed for approval unless the device has already been approved and sold for two years in the US, England, Australia, or Japan.
As of several years ago, independent third-party local agent registration is no longer allowed in India. All importers, distributors, and manufacturers must be listed on the CDSCO website and obtain import licenses to sell in India.
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.