India Local Networking Group

Hi All,
Appreciate if anyone has input on this matter.
Based on the recent update by CDSCO where starting October 2022, all class of imported medical device need to have Import License prior commercialization. And another significant update was to have the product registration number on the packaging.

My question is does this applies to the existing stock of the device which is alredy in India WH before the enforcement date? Since it was imported prior the enforcement date, hence the packaging is without the cdsco registration number.

Hoping clarification on this!

Hi Natrisya,

The products need to have the voluntary reg number before any sales and this is mandatory. Now if the products are not sold yet then you should update the packaging, if it is already at your customer location then you don't need to recall that, you can send them an updated label via IFU or any other means. Now when it comes to License, after 2023 OCT. You cannot commercially sell your products to anyone unless you have a license and that is the rule. 

Also, I would suggest you to visit the nearest CDSCO office and meet a Central DGCI officer to confirm this information before proceeding with your operations.