New TGA document warns dentists

The Therapeutic Goods Administration (TGA) has issued a document titled "New Regulatory Requirements for Dental Products" aimed squarely at informing dentists that using products not on the Australian Register of Therapeutic Goods (ARTG) is an offence.

The document explains in plain English that "direct importation of medical devices by a practitioner for supply to his/her patients is illegal unless the imported product is entered on the ARTG... This includes products ordered through mail order catalogues and products that a practitioner may carry in his/her suitcase when returning from an overseas trip.

"In order to enter the medical device on the ARTG, the importing practitioner must become a 'sponsor' under the [Therapeutic Goods] Act. The sponsor is responsible for ensuring that the medical device meets all regulatory requirements, including applying for the TGA to have the product entered on the ARTG and the payment of any associated fees and annual charges."

Dentists need to be aware of these changes to the Therapeutic Goods Act enacted in October 2002 and that the scope of medical devices regulated under the new system is much wider than under the previous system and very few products that fit the definition of a medical device are exempted or excluded from the regulatory requirements.

Dental products such as non-powered instruments and impression materials, for example, which were previously excluded, will no longer be exempt from ARTG entry after 4 October 2004. If you are currently using unregistered products, you have until this date to either sponsor registration of the product, or cease using it.

Custom-made devices such as removable dentures, fixed dental prostheses, bridges and crowns that are manufactured using standard off-the-shelf components (which must be listed on the ARTG) are currently not required to be registered.

The costs to register a product can range from approximately $1200 initially and $600 every year thereafter for a product with a European CE mark and all relevant certified manufacturer's documentation to tens of thousands of dollars and more for uncertified products.

There are provisions and exemptions under the Act to give individuals limited access to unapproved medical devices for use in clinical trials; via the Special Access Scheme (SAS); through an authorised prescriber and by personal importation.

In the case of the latter, unapproved medical devices can be imported by individuals where the product is intended only for use by the importer or a member of the importer's immediate family- NOT the importer's patients! There are also limits imposed on quantities of product that can be imported by a single act of importation and over any 12 month period.

The document concludes by stating: "It will be evident from [this document] that practitioners should be extremely careful regarding their legal position with respect both to direct importation, and to 'trying out' unapproved products on behalf of manufacturers. For example, evaluating unapproved products for overseas organisations is illegal, unless this is part of a clinical trial. Offences against the Act carry heavy penalties and may also invalidate professional indemnity insurance."