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Regulatory Roundup from Bahrain
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...
The Cyber-Security of Medical Device Companies
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....
New CFDA Regulations on Device Clinical Trials
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...
Reminder: UDI Implementation Due Date Approaching
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....