China - Start manufacturing before change approval?

nz1nz2

Starting to get Involved
#1
Hi All,
For China market, is there a restriction to manufacture a product with implemented change before the change was approved? (manufacture and not release) so you can only start production of a stock once the change is approved?
Sound weird to me but this is what our partner in China is saying (both drug products and medical devices)
Thank you in advance
 
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shimonv

Trusted Information Resource
#2
It doesn't make sense to me. What you manufacture in-house for non-commercial purposes, like prototypes, is your business.
Of course, you will have to have good manufacturing controls and records to show that these products are not approved for commercial distribution.

If you want another idea - you can build a "vanilla" (unfinished device) for inventory and complete the work once you get the clearance.

Cheers,
Shimon
 

fialor

Involved In Discussions
#3
So long as you do not place the device on the market (final release and sale (think of distribution chain)), then you can do whatever you like with the product.
You would manufacture, hold it in stock, and release it as a finished product once your change is approved. Good luck and let's know how it goes.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#4
AS I tell our internal team, we can do whatever we want product-wise; the controls matter when we lose control of the devices (eg ship, samples, etc.)
 
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