A clarification about reporting requirements is hitting the shelves for dental laboratory products. The newly clarified rules include “greater regulatory accountability,” due to a revision of mandatory reporting standards for importers and manufacturers. The requirements, introduced by the Therapeutic Goods Administration (TGA), will provide more detail and guidance on notification frequency. The revisions will cover the import and manufacture of custom-made dental devices such as bridges, crowns and dentures.
Australian Dental Industry Association (ADIA) chief executive officer, Troy Williams, said in statement that the ADIA welcomes the new changes.
“There had been some uncertainty across the dental community about the reporting obligations. As a result of ADIA’s engagement with the TGA, there is now much greater clarity concerning the mandatory reporting framework and this has been welcomed by industry,” said Williams.
The new regulations will require anyone who makes or imports custom-made dental devices to update the TGA with both the manufacturers name and business address. If the items are imported the TGA will also need to be notified of the importers details. The guides now clarify that you have a two-month notification period for these details as well as a description of the device.
“Local manufacturers and importers have long had an obligation to advise the TGA of their activities but, rather curiously, the regulations were silent as to when this should happen. Working with our members in the sector, ADIA was pleased to secure an amendment to the regulations that provided clarity on the compliance obligations,” said Williams.
“On behalf of the sector ADIA has been working with the TGA to ensure that the same standards for design, safety and manufacturing quality associated with custom-made medical devices are applied, irrespective of the country of manufacture.”
Briefings have been arranged to train dental professionals on the the requirements and can be accessed from the ADIA website.