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Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required ?

M

mpfizer

Involved In Discussions
#1
#1
We have MD 8 Lic. to manufacture Medical devices viz implants in INDIA , to sell the same is a whole sale lic. ie 20 21 B also required or can we do sales on the basis of our manufacturing lic.

Would appreciate help from anyone

Thanks

Michelle
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
M

mpfizer

Involved In Discussions
#3
#3
Thanks

so your view is that if we have a manufacturing lic. we do not need a separate whole sale lic. to sell the products we manufacture ...is my understanding correct?

i am referring to 20 21 B whole sale lic.
 
D

divyag

Starting to get Involved
#4
#4
When you apply for manufacturing license in the online sugam portal, one of the checklist is wholesale license. So considering you have wholesale license for the facility, you can sell.

Irrespective of wholesale license, the priority is to have the manufacturing license which you have. The license states "Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device"
 
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