TGA Red Tape Reduction Supports Local Manufacturers

Australian manufacturers of medical devices are better positioned to compete locally and globally thanks to regulatory change that cuts red tape according to the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of quality dental products.

Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 will allow third-party conformity assessment for Australian medical device manufacturers, giving them the same capacity as overseas manufacturers to utilise private conformity assessment bodies to demonstrate compliance in relation to medical devices approved for supply in, or export from, Australia.

"ADIA has been a long-standing supporter of this change which places Australian manufacturers on the same footing as overseas manufacturers in relation to conformity assessment certificates for many types of medical devices," said Troy Williams, ADIA Chief Executive Officer.

Overseas manufacturers - other than those manufacturing higher risk medical devices, such as some vitro diagnostic medical devices and products those containing tissues, cells or substances of microbial or recombinant origin, all of which require a Therapeutic Goods Administration (TGA) conformity assessment certificate - have the option of applying to the TGA for a conformity assessment certificate. They also have the option of using the services of a private conformity assessment body to assess their manufacturing processes and validate that they comply with relevant regulatory requirements. From 5 November 2014, local manufacturers will have the same option as a result of the regulatory amendments contained in the Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014.

"The regulatory amendments now allow Australian manufacturers the same flexibility that their overseas counterparts have, they can use the TGA or the services of a private conformity assessment body for most types of medical devices," Mr Williams said.

Most products used in dentistry are deemed to be medical devices for regulatory purposes and therefore subject to the Therapeutic Goods Act (Cth) 1989 which is administered by the TGA in order to maintain a national system of controls for the quality, safety, efficacy / performance and timely availability of therapeutic goods that are used in or exported from Australia.

"The dental industry has argued that regulatory duplication is prevalent across much of the TGA's work, with several TGA approval processes replicating those already undertaken overseas. The most recent set of amendments are a positive first-step in removing this unnecessary red-tape," Mr Williams said.

In actively lobbying for reform, ADIA is working towards 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.