China- Medical Device Administrative Control System (MDACS)
During the life-cycle of a medical device, changes may take place from time to
time. To safeguard public health, the information in the Medical Device...
Australia – Medical device regulation changes
Changes have been made to the regulation of:
software-based medical devices
prescription spectacle lenses
medical devices containing microbial, recombinant, or animal substances
medical device...
New Zealand – Guideline on the Regulation of Therapeutic Products in New Zealand
Pharmacovigilance is defined by the WHO as the science and activities relating to the
detection, assessment, understanding and prevention of adverse events or any medicinerelated...
Australia – Medical devices vigilance program pilot
The TGA is commencing a new Medical Devices Vigilance Program (MDVP). The MDVP will begin as a 12-month pilot. The pilot is designed to...
