May 17, 2019
Europe
Ireland medical device regulations are unified with other European Union countries and follow the same EU MDR and IVDR regulation. However, each country has their own Regulatory Authority (RA). In the case of Ireland, such RA is HPRA. Overview All medical...
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Jun 2, 2016
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...
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May 11, 2016
Consultant Post
China has become the second largest medical device market in the world. Sustained economy, population growth and a burgeoning aging population makes China a lucrative market for foreign medical device and pharmaceutical manufacturers. Nevertheless, China is considered...
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Feb 18, 2016
RegDesk News/Info
5 tips for sending your medical device to sanctioned country: Contact OFAC First The most important piece of advice we can give to anyone who is interested in sending their device to a sanctioned country is to schedule a call with Office of Foreign Assets Control...
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