This message was posted by a user wishing to remain anonymous
Dear All,
I am a bit confused in new company regarding international change assessment. The fact is that we have every week so many product changes and somehow unnessessary hours are spent to assess them whether it ishould be notified at international authority. Actually there are since years toning unsolved changes.
In my knowledge in most countries there is no guidance as in US and Europe, perhaps one sentence in regulation about when to change. For me it is easy either to have new registration or a kind lof etter to file in drawer. Ask authority whether to new registration makes no sence. What is your system to control change assessment in international RA? It helps even if you could reveal in whcih country is worthy to notify change at authority.
Maybe you can also address other thoughts:
QMS related items (change of one manufactuering site, change of one ciritical supplier), wait for next renewal or notify?
Product change (Labelling, new component list,) besides obviours significant change
If significant change in how country, would you have another tactic in term of product variant without this change in related international market? How to deal home country certificate?
Thanks for your effort and feedback.
regards