In order to speed up the availability of medical devices in India, the government has decided to do away with clinical trials for medical devices that have been approved and marketed for at least two years in European Union countries.
The data of safety, performance and pharmacovigilance of the device should comply with the standards of India’s Central Licensing Authority. Also, additional clinical investigation would not be required for that device while granting the permission.
The Medical Device Rules allows for an exemption in cases where the device does not have its predicate device (a legally marketed device that is not subject to premarket approval) in India before it is sold or distributed in India but has been approved by the regulatory authority in the US, the UK, Australia, Canada or Japan
According to officials in the Central Drugs Standard Control Organisation (CDSCO), the proposal seeks to remove regulatory bottlenecks while ensuring the availability and increased access to state-of-the-art devices in the Indian market.