The Indian CDSCO is now discussing the need to test more devices locally to obtain Indian medical device approval. Recently, a task force has been established to determine what needs to be done to increase India’s testing facilities. Various categories of medical devices may need different types of tests. Currently, only a few devices require local testing in India whereas almost all IVDs need local testing for approval. The device industry is combatting this potential change claiming that their imported products have already been tested and approved overseas. The device industry is now pushing the government to increase testing labs only for local Indian device manufacturers who do not have in-house capabilities. These regulations are still in process and not officially issued yet.
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.
Source used in the article: https://www.advamed.org/wp-content/uploads/2018/01/medical_devices_in_india_-_an_agenda_to_effective_healthcare_delivery.pdf