Ann: CE, FDA and CFDA Approval - Guangzhou Production Facility, page-284

Guys, just so we know what has been approved, to the best of my knowledge this is where we are:

China: 'Green Channel' but as yet no approval for Prizma or Patch. Factory approval from CE, FDA and CFDA.
US: Approval for Prizma, no approval as yet for Patch
Europe: Approval for both Prizma and Patch.
Australia: Approval for Prizma, no approval as yet for Patch.