Difference between Notified and Non-notified Medical Devices| Medical Devices Regulations| Corpbiz

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In India, medical equipment has always been mainly uncontrolled. That has lately changed. According to Ministry of Health and Family Welfare Notification No. G.S.R, 78(E) dated January 31, 2017, the Medical Devices Rules 2017 became applicable on January 1, 2018. There have been distinct requirements for medical devices that have been notified and those that have not been informed.
Non Notified devices-There is no regulation in India for any gadgets that are not on the list of Notified Devices. These devices must be listed on the CDSCO website. Foreign firms who wish to sell these gadgets in India must obtain an IAA (Indian Authorised Agent).
Notified Devices: The Notified list contains 37 categories of devices that are regulated by the CDSCO and need prior approval from the CDSCO before being marketed in India. With each type of application form submitted to the CDSCO, a different set of supporting documents is needed.
The selection of applications varies according to the device type, applicant characteristics, operations, and home country approval. The CDSCO grants licences for device testing, import, or manufacturing after carefully evaluating each application.
In accordance with the Medical Device (Amendment) Rules - February 2020, which came into effect in April 2020, all non-notified medical devices may voluntarily be registered with the Central Licensing Authority (CLA) through the medical device online system.
India’s Medical Device Regulations for Notified and Non-Notified Medical Device
As discussed the differences lets move on to the regulations in india for these devices.In India, where a high number of notified and non-notified medical devices are imported, global medical device makers have a good potential. The Indian medical device sector is predicted to increase significantly due to the existing low per-person expenditure on medical equipment(growing graph).The Notified Devices are the devices that are regulated under the Medical Devices Rules (MDR), 2017 by the CDSCO - the Health Agency in India that oversees the regulation of notified and non-notified medical devices. In February 2020, the CDSCO issued two notifications, including the Medical Devices (Amendment) Rules, 2020, which went into effect on April 1, 2020. Medical devices were also given a new definition as part of the other notification. As a result of the change and the new definition, the CDSCO is now in charge of overseeing all devices. Only 37 classes of medical devices and IVDs were governed in India prior to these notifications. “Newly Notified Devices” are the new devices that have been brought under the jurisdiction of the CDSCO.
The “Newly Notified Devices” are divided into 24 medical device categories and 3 IVD categories. According to the risk associated with each device, both Notified and Newly Notified devices are categorised into 4 Classes: A, B, C & D. There are low-risk Class A devices and high-risk Class D devices.
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