TGA Pushed to draft new laws on dental laboratory work

The Therapeutic Goods Administration (TGA) is being encouraged to adopt recommendations from a recent Senate inquiry to increase the amount of information provided to patients about the source of their dental laboratory work. The move comes from the Australian Dental Industry Association (ADIA), the peak representative body for suppliers of quality dental product.

"ADIA has made formal representations to the TGA, requesting that the regulator adopt a Senate committee recommendation to consider if the approach used in the United Kingdom of requiring a statement of manufacture to be provided to patients, and retained by the dental practitioner, has merit," said Troy Williams, ADIA Chief Executive Officer.

In a detailed submission tendered to the TGA Medical Device Reforms Reference Group, ADIA has set out a series of specific proposals including a mandated requirement that a patient be advised that a statement about their custom-made dental appliances is available on request. This statement must be drawn up by the manufacturer or their authorised representative and should contain certain information including the name and address of the manufacturer and a statement that the device in question conforms to the essential principles set out in the regulatory framework administered by the TGA.

"Senators who participated in last year's inquiry clearly thought that such arrangements have merit, and ADIA agrees. We are asking the TGA to be proactive in this matter and set about the task of strengthening the regulatory standards for laboratory product," Mr Williams said.

It is important to note that all custom-made dental appliances, whether manufactured in Australia or overseas, are required to meet the same regulatory standards set out in the Therapeutic Goods Act (Cth) 2009 and subordinate regulations. The regulated manufacturing processes include adherence to conformity assessment procedures which mandate compliance with a defined set of outcomes for the manufacturing, performance and safety of medical device.

"In proposing reform, ADIA's objective is to ensure that the TGA administers a regulatory framework that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing dental laboratories from an unnecessary regulatory burden," Mr Williams concluded.