A list of medical devices that fall within the Class A, Class B, Class C, and Class D categories were included in the 2017 New Medical Device Regulations (MDR). Based on the level of risk they pose, Class A and B devices are categorized as low-risk and moderate-risk devices, respectively, whereas Class C and D devices are classified as high-risk and extremely high-risk devices, respectively. To be approved for a manufacturing license in India, manufacturers of Class C and D devices must submit an application to the Central Drugs Standard Control Organization (CDSCO).

The emergence of digital health technologies has fast-tracked the evolution of the healthcare sector. New-age healthcare products like wearables, telemedicine, and clinical decision-making tools use Artificial Intelligence (AI) and Machine Learning (ML) algorithms. Global Health Agencies, including CDSCO, are gearing up and devising new regulations to address the transformation.

Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.

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.