From 1 July 2017, the maximum penalty for the importation or supply of dental products without first meeting Therapeutic Goods Administration (TGA) requirements will exceed $1 million for individuals and $10 million for companies in some cases.
The peak business organisation representing dental product manufacturers and suppliers, the Australian Dental Industry Association (ADIA), has noted that most dental products are deemed by the TGA to be “medical devices” for regulatory purposes. It is in this context that the new fines are particularly relevant to those importing dental products then seeking to supply those products locally or use them on patients.
“The increased fines make it clear it’s simply not acceptable to buy medical devices from overseas online stores then supply them within Australia or use them on patients without complying with the TGA’s regulatory standards,” said Troy Williams, ADIA Chief Executive Officer.
If a health professional supplies a medical device to the Australian market—and the legal definition of supply includes importing then using products in clinical practice—they become legally responsible for meeting the TGA’s requirements. These responsibilities include applying to the TGA to have each kind of medical device included on the Australian Register of Therapeutic Goods (ARTG) unless a specific exemption applies; ensuring the device continues to meet all legislative requirements once on the market; reporting any adverse events or problems; and taking corrective or preventative action, such as recalls, if necessary.
“The chatter in some online forums is that it’s okay to buy dental products from overseas then supply these products locally or use them on patients. This increase in fines should provide a clear signal that the Australian Government thinks this is not on,” Mr Williams said.
Importers of medical devices need to be sure the products meet the TGA’s standards, the “essential principles”, concerning safety and performance characteristics of medical devices. They also need to ensure that a quality management system was in place with regards to the manufacturing process. They the then need to apply to the TGA for an ARTG entry for each kind of medical device, even if another business already has an ARTG entry for the same product.
Under the legislation, a person faces maximum penalty of $1,050,000 if they supply a medical device for use in Australia that does not comply with the essential principles in circumstances where the TGA has not consented to the supply or a specific exemption has been granted. A company faces maximum penalty of $10,500,000 in such circumstances.
“These fines are huge, but they are easily avoided. Rather than buy products from overseas online, healthcare professionals should simply buy from their local ADIA member business who has already taken care of the regulatory compliance obligations,” Mr Williams said.
The higher penalties arise from passage of the Crimes Amendment (Penalty Unit) Bill 2017 that increased the amount of the Commonwealth penalty unit from $180 to $210 from 1 July 2017.