The regulatory process for registering a Medical Device in India

[shimonv]

Hi Fellows,
One of my clients in Israel asked me about the regulatory process for registering their product in India. It is a pain monitoring device.
From what I gather - submission is required for a very specific types of devices known as "Notified Medical Devices" and pain monitoring is not in that list.

Can anyone confirm this? It would be cool if no regulatory activity is required.

Best,
Shimon

 

[shimonv]

A kind person from India confirmed that such a device is exempt from registration. Thanks !

 

[mihzago]

Keep in mind that India is implementing new medical device regulations; the new requirements, including the classification are more in line with GHTF/IMDRF and jurisdictions such as Canada, Australia, Brazil, etc.
These new regulations are to take effect in January 2018, I believe, so keep your eye out for the changes.