Senate Report On Medical Device Reform Legislation Welcomed

A Senate Committee report recommending the Australian Parliament pass proposed amendments to the Therapeutic Goods Act (Cth) 1989 has been welcomed by the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of dental products.

The Therapeutic Goods Amendment (20016 Measures No. 1) Bill 2016, if enacted, allows the Therapeutic Goods Administration (TGA) to decrease the regulatory burden on manufacturers and suppliers of dental products through:

• Providing industry with more flexible and timely pathways to market.
• Enabling dentists and oral health professionals to access new medical devices faster.
• Increasing the TGA's collaboration with overseas counterparts to cut the regulatory burden.
• Enhancing post-market monitoring of the safety of products.

The bill had been referred to the Senate's community affairs legislation committee which handed down its report on 27 March 2017. The committee's report recommended that the legislation pass.

Of particular importance to the dental industry are amendments within the bill that will enable the Department of Health to designate Australian companies, in addition to the TGA, to undertake conformity assessments of medical devices," said Troy Williams, ADIA Chief Executive Officer.

Conformity assessment is the systematic examination of evidence and procedures to determine the safety of a medical device and whether it is acceptable and performs as intended. These conformity assessments will be used in deciding whether medical devices should be included in the Australian Register of Therapeutic Goods (ARTG), the list of medial devices, medicines and other therapeutic products that can be lawfully supplied in Australia.

"This alternative approach for conformity assessment will provide a faster and possibly cheaper market approval pathway for innovative patient diagnostic and treatment products. It's a long over due reform, one that ADIA has been a strong proponent for, so we look forward to the passage of the legislation that will see this become a reality," Mr Williams said.

The changes are the initial instalment of a reform program arising from an expert review of medicines and medical device regulation. The Australian Government’s response to this review released in 2016 and was endorsed by ADIA.

"In actively lobbying for reform, ADIA's goal is a regulatory framework for dental products that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden. The passage of this bill is an important milestone towards this goal," Mr Williams concluded.