China FDA ( CFDA ) has published Reg No. 25 “Good Clinical Practice (GCP)”. It’s a substantial rework of the old 2004 edition with much stronger requirements for trial practice and for productiojn of trial devices.
Archives for April 2016
Australia’s Therapeutic Goods Administration (TGA) has introduced new regulations to require online notification within 2 months of Australian manufacture or the importation of a custom made device. Custom devices are wide ranging from simple dental appliances to 3D printed implants. Read on to learn about the TGA requirements or join a workshop on 3D printing in medicine.
It’s here: the long awaited 2016 update to ISO 13485 was published at the end of February. This revision is a big shake up of the venerable devices quality standard. It’s going to need time, effort and planning for transition to the 2016 edition.
In conjunction with AusMedtech 2016 conference in Adelaide in May and leading Notified Body TUV Sud, we are hosting a full day workshop on Transition to ISO 13485:2016. It’s on 9 May, immediately before AusMedtech 2016 and there are discount rates for attendance at both events.
Australia’s Therapeutic Goods Administration published a draft version of the Clinical Evidence Guidelines on March 15th 2016. TGA has always had high expectations for Clinical Evidence and the Agency clearly has no intention of relaxing their requirements. If you are in the process of preparing a CER, the guidance should be your mandatory bedtime reading!