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As others have said this very much depends on how the QMS is set up. In settng up new QMS systems I prefered to be quite explicit about how the boundary is defined between "R" (which is not controlled) and "D" which is under design controls.  I had one client who had a design control SOP which explicitly ...

Hi Karthik, I am assuming the primary purpose of the product is as a device (you don't state what it is).    However if the therapeutic action is primarily as a result of the growth factors influencing the tissue then you would have a medicine.  This debate went on for some time when freeze dried ...

HI Joy I am not aware of any single link and even if it existed it would rapidly become out of date.  however you can consolidate the contact information for the individual agencies into a small number of sources, all of them harmonization bodies: www.imdrf.org for US, Europe, Australia, Japan, ...

Yes the IND requirements apply if you want to use the trial data in a follow-on US FDA submission.  FDA accept international data providing they comply with local GCP requirements which are considered equivalent to US GCP.   So FDA is unlikely to drill down to matters like detail of local labelling in ...

Labelling for supply into Australia should comply with the Australian requirements.  Howeer these are very similar to US requirements - require to be labelled for investigational use and identify the trial sponsor. Although you may have a US IND, that has no status in Australia - you need to have ...