Class III Medical Device with CE Mark Approval - India Registration Process

[jampot]

Our company manufacture a Class III medical device with CE mark approval.

We have been approached by a distributor from India who would like to sell our device in India. Our contact has provided a list of documents that they indicate are necessary to Register the product and company in India

1) Plant Master File Duly Notarized

2) Drug Master File Duly Notarized

3) WHO,GMP Certified Duly Notarized

4) Free Sale certificate the country of origin

5) Power of Attorney duly notarized and authenticated fom the INDIAN EMBASSY the country of origin.


As our product is a synthetic device with no pharmaceutical components I don't believe a Drug Master File is necessary, furthermore we do not possess a GMP certificate.

It would be appreciated if anyone who has recently been through the registration process in India could offer advice and interpretation of the terms used above.
For example is a Plant Master File the same as our Device History Record ?

Many thanks in advance

[Gert Sorensen]

Just bumping this thread. Is anybody able to give input on this one?

[chris1price]

Hi

Have a look on the Indian CDSCO website. specifically at http://www.cdsco.nic.in/medical%20device%20A42.html

This lists the types of devices now regulated and the documentation that is required for registration.

[bio_subbu]

Hi Jampot..

Can you tell me about which type of device. what is the intended use..

[jampot]

Chris
Many thanks for the link provided. Is extremely helpful.

Jampot

[jkonholm]

In Reply to Parent Post by chris1price

Hi

Have a look on the Indian CDSCO website. specifically at http://www.cdsco.nic.in/medical%20device%20A42.html

This lists the types of devices now regulated and the documentation that is required for registration.

Kaspersky Internet Security 7.0

The requested URL http://www.cdsco.nic.in/ is forbidden

[harry]

In Reply to Parent Post by jkonholm

Kaspersky Internet Security 7.0

The requested URL http://www.cdsco.nic.in/ is forbidden

I do not have any problem accessing both the links from over here. Problems could be due settings on your side.

[AG Kumar]

Hi

Medical Devices are regulated by Indian Agency fairly, but unlike USFDA in detail. If your organization has approval with MHRA or EU directives' specified notified bodies, it would become pretty easier for you to get registered with Indian FDA.

For your convenience, I am attaching the 'Drugs & Cosmetics Act' and if you refer through pages 535 and 304 & 309, you may get more insight with the requirement.

AG Kumar