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.
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.