Australia and Oceania
The Australian regulatory authority, the TGA, is taking steps to improve the existing regulation in the sphere of manufacturing and use of medical devices through what is known as the “Action Plan”. The main goal of the Action Plan, published on April 4, 2019, is to...
Asia
The National Health Regulatory Agency (NHRA) in Bahrain, has released a circular regarding the importation of medical devices to the country. Medical device shipments must now be pre-approved by the NHRA before arriving at Bahrain’s ports. Failure to get...
North America
As the benefits of software become increasingly present to healthcare systems, its risks do too. While software can increase the efficiency and effectiveness of healthcare, it can also create greater vulnerabilities. The medical device industry in particular has had...
Asia
The China Food and Drug Administration (CFDA) has been changing how medical devices are regulated by expanding and updating their laws. They have released multiple draft documents which elaborate on the caliber of medical device clinical trials and devices that may be...
North America
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs. The next phase of the system will be implemented...
