Is the Australian government establishing systems to place the European CE mark on products manufactured by Australian companies?
A.We are currently modifying our approval system to resemble the European model. When that’s in place early this year, we will develop a system for CE marking in Australia without going through European notified bodies. Q.According to information from the World Medical Market Fact File, 22% of Australian medical exports went to the United States in 1993. Is the United States one of Australia’s biggest markets for medical products? What special concerns do Australian medical device manufacturers have about the U.S. market? A.The Pacific islands, Papua New Guinea, and New Zealand are the largest export markets for Australian-produced products. After that come the United States, Asia, and Europe. One of the primary barriers Australian manufacturers encounter when trying to access the United States is the product approval process. That doesn’t mean to say that the U.S. FDA isn’t trying to address some of the problems with its system for instance, its approval times have been reduced substa
Related Questions
- Why is GBD Importing encouraging Australian business to use and sell overseas products instead of using Australian products manufactured by Australian owned businesses?
- Which suppliers are participating and which products are registered under the Australian Government Digital Switchover Labelling Scheme?
- Can any one simply put CE Mark on his or her products?
