How to register a non notified Medical Device in India

[NhuTuyet]

Hello everyone!

First of all, Happy New Year!

I have done some research regarding the medical regulation in India (aimedindia.com, cdsco.nic.in, emergo, ...) but I could not find a complete answer on how to register a non notified medical device (we are manufacturing dental implants).

I understood that the fact that we have the CE marking will help us to register our products and that we need to have an import certification.

What are exactly the steps for the registration of non notified medical devices in India? How long does it take?

Thank you for your help.

Have a nice day.

NhuTuyet.

 

[J0anne]

Hello NhuTuyet. What do you mean by a non notified medical device? Thanks.

 

[NhuTuyet]

Dear J0anne,

I meant that dental implants are not on the list of notified medical devices (http://www.cdsco.nic.in/writereaddata/list of notified medical device.pdf) or I cannot find them ...

Thanks for your answer.

NhuTuyet.

 

[J0anne]

The manufacturer has to be registered (1.5k USD) and each medical device has a registration fee as well (1k USD). The manufacturing facility will require an audit for a further fee (5k USD). Call +91 11 23236965 (CDSCO in New Delhi) for the form 'Application of issue of Registration Certificate for import of drugs into India under the Drugs and Cosmetics Rules 1945' - The manufacturer OR manufacturer's appointed agent may apply. http://www.cdsco.nic.in/forms/default.aspx

 

[somashekar]

If it is not notified, you do not register.
Who imports, he can get a certificate of free sale and commerce certificate for you from the JDGFT (Joint Director general of foreign trade) through an application. This certificate (Annexure B) will clearly state the products, as well as state that they are not covered within the drug control act (Annexure A)
Such a certificate will be valid for two years

 

[Olaaa]

Import requirement for non notified Medical Device in India

Hello,

There has been some chatter about an India-specific label requirement for importation of non-notified medical devices in India. Can anyone advise on the what this label should include please? Thanks in advance!

Regards
Ola