Ever since the World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic, the global health authorities and life sciences organizations are quickly responding to the situation to see how they can make meaningful contributions.
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.
On May 15, 2019, Central Drugs Standard Control Organization (CDSCO) of India has published a notification regarding the classification of new devices, which are notified for regulation. As per the notification, the newly regulated medical and in vitro diagnostic (IVD) devices will be classified as per the provisions of Medical Device Rules – 2017. Basing on the rules, the classification criteria are decoded below.
Do you know? Out of 5000 types of medical devices marketed in India, only 23 types are currently regulated by the Central Drugs Standards Control Organization (CDSCO). To increase the ambit of Regulatory supervision and ensure efficacy and safety of medical devices, in early 2017, the CDSCO drafted and published the Medical Device Rules – 2017, which were made mandatory from January 1, 2018.
