The CFDA has recently published a news article summarising the meeting held for the ‘Reform of Medical Device Review and Approval Framework’ held on the 18th Nov 2015.
Archives for December 2015
TGA has introduced some revisions to IVD regulations which bring in some necessary streamlining of the regulations as well as remove the overly prescriptive reference to the Notifiable Diseases List.
The Asian Harmonization Working Party met in Bangkok in November. We take a look at the latest developments including publication of new Combination Products White paper and plans for new guidance development, a slew of new guidances on standard submission dossiers, software regulation, adverse event reporting and more, as well as range of updates from member economies