Change management with CFDA approved devices

[JDVERT]

Hi all,

We are in the last stages of having our active medical device approved in China and are looking to update our QMS documentation to ensure we include the right information to manage changes correctly going forward.

I cannot find any guidance on managing changes to existing licenses.

We have a firm grasp on software changes but other than that it would seem there isn't much available.

Could anyone provide a reference to guidance or even share their experience with managing changes with an approved medical device in China?

Thank you in advance.

 

[shimonv]

Hi JDVERT,
There is a CFDA (now NMPA) guidance that talks about changes in registration; it's called "CFDA Provision on Medical Device Registration'. (CFDA regulation NO.4)"

My partner in China pointed out that these guidelines are very general. In order to make the right decision on what can and can't be changed, you need to know the device, the purposed change, and to evaluate the impact on technical performance (as declared to NMPA); sometime consultation with authorities is required.
Hope this helps. If you'll need assistance with developing an internal change control procedure, please contact me privately.

Best,
Shimon