Approvals for medical devices may ease with new classification-- 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. Experts said that there’s a need to constantly update the list so that its purpose doesn’t get defeated. For instance, if a product classification is not known, the manufacturer would not be able to submit its applications, and it will cause delays till the CDSCO is approached, and informed about the classification based on other jurisdictions like the US, EU or Singapore. for more information. contact : 9266665201 Email - info@acplgroupindia.co.in