CDSCO Amends the Medial Device Rule 2017
To strengthen the regulations of medical devices in India, the Central Drugs Standard Control Organization (CDSCO) has released two final amendments to the Medical Device Rule 2017. The amendments are expected to provide more clarity on the scope of medical devices and establish an expedited registration route for certain devices. The CDSCO has announced that both the amendments will come into effect from April 1, 2020. But how exactly will they impact the Indian medical device Regulatory scenario? Let’s take a look.