For me, this is one of the many unclear points in Chinese regulation for Medical Devices: how to manage a change to an existing device registered at the SFDA.
I am interested in sharing experience with people that already have dealt with this issue.
For performance changes or introduction of new features we have always submitted a new registration.
But what can be considered a "minor change" to the device, so that a new registration is not needed?
I see that during the first registration phases the SFDA is very keen on getting photos of every part of the equipment, so I wonder whether a change in colour of the plastic cover or a in the shape to keep it in fashion needs a formal communication to the SFDA.
Does anybody have ideas or suggestions for source of information?
Thanks.
m.p.
I am interested in sharing experience with people that already have dealt with this issue.
For performance changes or introduction of new features we have always submitted a new registration.
But what can be considered a "minor change" to the device, so that a new registration is not needed?
I see that during the first registration phases the SFDA is very keen on getting photos of every part of the equipment, so I wonder whether a change in colour of the plastic cover or a in the shape to keep it in fashion needs a formal communication to the SFDA.
Does anybody have ideas or suggestions for source of information?
Thanks.
m.p.