Regulatory Requirements for Medical Device Manufacture in India

Ajit Basrur

Staff member
Admin
#1
Hi,

We intend to start manufacture of Medical devices in our plant in India for domerstic and regulated markets. Can I get info on the regulatory requirements to be fulfilled especially for Indian markets ?

:thanx:
 
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Al Rosen

Staff member
Super Moderator
#2
Hi,

We intend to start manufacture of Medical devices in our plant in India for domerstic and regulated markets. Can I get info on the regulatory requirements to be fulfilled especially for Indian markets ?

:thanx:
I believe that they have very little in the way of regulations. Almost anything can be marketed there.
 
M

Madly RA'd Woman

#4
Here is a link to a website that I have found to be helpful; it has some contact information that might be of assistance. The information is from 2000, so it may be outdated:

http://www.ita.doc.gov/td/health/indiaregs.html

Here is a consultant's page who sells regulatory information for the Indian market. i have heard him speak at the RAPS event in 2006, and I found him informative, but I have not bought any packaged information, therefore I cannot attest to the content.

http://www.pacificbridgemedical.com/publications_India2.html

(FYI - I hold no affiliation to the consultant or his business.)

Good Luck!
Madly RA'd
 
I

intrestedparty

#5
For medical device manufacturing there no any regulatory requirements in india. So you can start it. Now Govt is planned to set up Org called IMDRA (Indian Medical Devices Regulatory Authority). Now IMDRA is coming under Ministry of Defence (DRDO), but this IMDRA has no control on market or public. This is only for Defence.

Regards
Karthi.T
 

Ajit Basrur

Staff member
Admin
#6
Thnaks Karthi. Btw, I looked at the Drugs Control of India website and saw that they are imposing some regulations on medical devices. Also the Schedule M has one section exclusively for Medical Devices.

Do you have any idea about "Manufacturing License" and other registration documents ?
 
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