Following the closure of the Russian regulatory agency amid corruption scandals in May, the Russian ministry has now extended the deadline for establishment of a new registration process to 2017
Archives for July 2013
The Australian Therapeutic Goods Administration (TGA) has recently launched the Database of Adverse Event Notifications (DAEN) – an online database, similar to FDA’s MAUDE database. This is a further step in the strengthening of postmarket monitoring by TGA. Manufacturers need more than ever to understand their responsibilities, and understand that their Australian postmarket reports are now in the public domain.
The transition period for upgrading Australian regulatory approvals for implantable joint prostheses from Class IIb to Class III has less than a year left to go, and the fee waiver has now expired.