What are the Government of India requirements to sell OEM Medical Devices in India?

Hello all!

Can anybody tell me what requirements have the Goverment of India for OEM medical devices?

The Original equipment manufacturer is a European company.

Thank you

Re: OEM Medical devices to sell in India

Depends on the type of medical device, you may need to have a license to import and / or manufacture.
For more details please see CDSCO

Re: OEM Medical devices to sell in India

somashekar said:

Depends on the type of medical device, you may need to have a license to import and / or manufacture.
For more details please see CDSCO

Click to expand...

OEM is too broad an category to interpret
anyways,
http://cdsco.nic.in/Medical_div/medical_device_division.htm
fyi pl.

Re: What are the Goverment of India requirements to sell OEM Medical Devices in India

In addition to somashekhar's advise, pls refer the link from EMERGO for some additional information on India's regulatory process.

Note: I am in no way connected with Emergo and visit the site for information.

Re: What are the Government of India requirements to sell OEM Medical Devices in Indi

Thank you all,

That is very useful information!

Re: What are the Government of India requirements to sell OEM Medical Devices in Indi

If a CE marked/FDA cleared dental device is not on the notified/gazetted list, could someone please describe in detail the exportation/importation process? Also, since the Indian marketplace seems highly regionalized, could someone provide a listing of possible dental device distributors to effectively cover India overall?

Re: OEM Medical devices to sell in India

Yes! A lot if you wish to import to India and much lesser if you wish to export these out of India. It appears that you wish to bring in OEM manufactured into Indian Market. You would need to register most products with CDSCO depending up on criticality.

Regards