New TGA Device Regulations may affect some dentists and labs

On October 4, Australia became the first country in the world to adopt the international regulatory model developed by the Global Harmonisation Task Force for the regulation of medical devices. The new model, which the Australian Therapeutic Goods Administration (TGA) is implementing, has wide ranging effects for the dental and medical communities.

Dentists should be aware of the implications of the new system even though, for the most part, administration and compliance will be the domain of the dental industry which manufacturers, imports and/or supplies the products used in dental practice.

One of the major changes is that the new system now has a much more comprehensive coverage and no longer allows the ad hoc importing of small quantities of products as the regulations require pre-market approval, record keeping and other compliance criteria be met. It will generally not be worthwhile for an individual dental practice or dental laboratory to continue to import products when the administrative costs make it literally prohibitive to achieve any savings over products available form Australian-based suppliers.

The new regulations state that all instruments, equipment and materials that come into contact with patients "are subject to controls by the TGA" which means that the importer must register the full scope of the goods being imported and/or locally manufactured with the TGA which includes declarations of risk (which class of risk the product is subject to) and appropriate proof that such risks are being addressed by adequate controls during manufacture.

The new regulations will mean, for example, that dentists and/or labs which have crowns and other prosthetic devices completed overseas such as in Hong Kong or the Philippines, will now need to ensure that the materials used in their manufacture comply with TGA registration requirements as such shipments can be held up at customs for verification purposes. This is an interim measure only while the new system is implemented and after October 2004, registration will become compulsory on all such products.

In addition, dentists who imported some components for their own practice use, such as implants, will need to immediately register these products or cease using them. Practitioners who visit overseas dental conventions and exhibitions and purchase a few products such as handpieces, burs and/or hand instruments must be aware that they are in breach of the new regulations.

The self-importation clause "for personal use" is still there but it will be strictly checked by quantities, viz. personal use quantities and not commercial quantities which are subject to registration (for example, you can import a few scalers but not dozens).

And, for the first time, products such as impression materials, must now be listed.

The Global Harmonisation Task Force was initiated by the European Union in response to the reduction of physical borders separating countries. This increased freedom of trade has spawned the need for supranational structures of orderly controls to ensure that the removal of the physical borders does not lead to the lowering of standards for therapeutic substances and devices.

Cost pressures in high labour cost countries have seen many leading world brands being displaced from their original manufacturing site to countries where lower wage structures and differing labour laws enable more economic production. These are the very moves by industry which prompted regulators to pass laws to ensure that such moves did not come at the expense of efficacy or safety of the products.

Hence the European Union agreed to set-up a fairly strong network of controls/laws which have been adopted by Australia, ahead of the EU, as Australia is developing a solid reputation as an ideal place to produce hi-tech devices such as pacemakers, of which the majority are exported worldwide.

A component of the new regulations is to categorise the risk that a device may pose during its use/application and to then specify a commensurate level of controls for the manufacturer to implement to ensure that they are adequately planning for the safe application of that product to minimise the risk posed to the user/operator and of course the patient.

The adoption of an international system of regulation will ultimately mean that products which are registered overseas under the system may be available more rapidly in Australia and potentially at a reduced cost as the statutory requirements that need to be met to satisfy our own TGA will already have been satisfied when registration or listing of the product is sought here.

The Australian TGA has a proud record of achieving good public health and a high safety record for the population and the new system will allow this tradition to continue.

The enormous range and variety of price competitive, high quality dental products currently available in Australia is unlikely to be affected by the new system. The dental industry is adapt at complying with the requirements of the TGA and is in the process of implementing the new system which will take some years to fully changeover all existing products. New products will need to be registered or listed under the new system from day one.

If you are sourcing all of your dental products from an Australian distributor, then little will change. If, however, you are bringing in products from overseas, be aware that using unregistered or unlisted products in dental practice will expose you to the risk of prosecution and may jeopardize protection under existing professional indemnity or public liability schemes.

There has literally never been a better time to support the Australian dental industry which invests heavily in ensuring the products you use are both safe and compliant.

Thanks to Armin Roth for compiling this article on the new regulations. Armin is a director and past president of the Australian Dental Industry Association and represents the organization in relation to standards and regulatory affairs. He is also well-known for his work at Halas Dental.