Support - Regulatory
Uscom is committed to maintaining the highest standards in regulatory compliance prior to entry of each of its markets worldwide.
Australian regulatory clearance, a Certificate of Listing by the Therapeutic Goods Administration (TGA) was issued in November 2001.
In the United States Uscom received the necessary regulatory clearance (FDA 510K notification) in February 2005. For Europe, Uscom received CE Mark certification in December 2003. For China , Uscom has been issued regulatory approval by the State Food and Drug Administration (SFDA). In Japan, the company received an approval certificate from the Ministry of Health Labour and Welfare in November, 2004.
| REGION | APPROVAL | STATUS | LINK |
| Australia | TGA Listing | APPROVED | View Listing |
| EMC and Safety (IEC60601-1-2:2001) |
APPROVED | View Report | |
| Safety (IEC60601-1) |
APPROVED | View Report | |
| Quality (ISO 13485:2003) |
APPROVED | View Certificate | |
| Europe | CE Mark | APPROVED | View Certificate |
| US | FDA 510K Notification | RECEIVED | View Notification |
| Canada | Canadian Listing | APPROVED | View License |
| China | SFDA Number | APPROVED | View Certificate |
| Taiwan | Dept of Health License | APPROVED | View Certificate |
| Japan | Ministry of Health Certificate | APPROVED | View Certificate |
Full patent protection was secured for the Australian market in mid 2002.