The Central Drugs Standard Control Organisation’s (CDSCO’s) draft rules for re-classification of medical devices based on their risk profile has received wide support from the industry, as it will allow cetralaised, faster approval of high-risk equipment. The classification of medical devices are done at the state and central level based on the risk profile of the devices. For instance, the manufacturing of class A and B devices, which have lower risks involved, are cleared by the state governments. The production of class C and D devices are cleared by central agency CDSCO.
Prior to this draft, the classification of the devices were left to the discretion of the state governments, especially in cases of new non-classified devices. “In some cases, the companies have to face issues with state governments because their interpretation of the risk were different from the device manufacturers. Now, that ambiguity has been addressed to a large extent. It would reduce the delays in new product launches,” said head of medical device association, on condition of anonymity.