Jun 3, 2016
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...
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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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Nov 17, 2014
South America
by Isabel L., Consultant on RegDesk In Argentina, medical devices are regulated by the ANMAT (National Administration of Drugs, Food and Medical Technology). This body (similar to the American FDA), under the Ministry of Health, monitors the quality of all...
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Oct 9, 2014
Consultant Post
by George C., Consultant on RegDesk As a result of fraudulent medical devices entering the US market (such as orgone accumulators and other quack medical devices), an increase in the number of medical device recalls, and various medical devices causing death and/or...
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