Chinese Authorized Representative - What are the regulatory risks?

[wrensch]

Hello,

All of our products were registered through company that also acts as our CAR. One of the product lines will be expiring and we are considering using our dealer for the registration process for cost and timing reasons. What are the regulatory risks associated with this?

Any advice is greatly appreciated!

 

[shimonv]

Hi wrensch,
I can think of a two risks:

1. If the dealer is not experienced with regulatory affairs your time to market is affected. The higher the device classification the more complicated it could get.
2. The dealer's name is on the license. If you want to break the bond later on you will need to update CFDA. Not a big deal but you should be aware of it.

If you take this route, be sure to keep copies and log of every document and every activity that was performed by the dealer.

Good Luck.
Shimon

 

[wrensch]

Hi wrensch,
I can think of a two risks:

1. If the dealer is not experienced with regulatory affairs your time to market is affected. The higher the device classification the more complicated it could get.
2. The dealer's name is on the license. If you want to break the bond later on you will need to update CFDA. Not a big deal but you should be aware of it.

If you take this route, be sure to keep copies and log of every document and every activity that was performed by the dealer.

Good Luck.
Shimon

Thank you Shimon! Is there a rule against having one CAR hold the registration for some products and a different CAR for others?

 

[shimonv]

As far as I know, there is no such rule.
These things are managed on a 'per license' basis.

-Shimon