North America
Many manufacturers believe that selling their product or device without FDA approval is acceptable. If people buy it, but is this breach in ethics worth the potential consequences? If caught marketing an unapproved product, the FDA may issue a warning letter...
RegDesk News/Info
With emerging markets projected to account for 30% of global pharma market development, it’s important to note why having local consultants in those markets is vital. If not local, consultants are much more expensive. If a US consultant were hired for a project...
Europe
Last Friday, after a three year gridlock, the Council of the European Union came to an agreement on the reworking of regulatory legislation on medical devices and in vitro diagnostics which will impact both manufacturers and regulatory authorities. The European...
Asia
Regulators in Hong Kong’s Medical Device Control Office issued a new list of recognized Hong Kong medical device standards for medical devices this past month. This is a huge step as the region is only recently implementing regulatory of Hong Kong medical device...
