ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

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TGA Reporting Obligations For Local Labs & Importers

TGA Reporting Obligations For Local Labs & Importers

18th May 17

Summary —

Local manufacturers and importers of dental laboratory products are being urged to step-up and meet their legal obligations by reporting their activities to the Therapeutic Goods Administration (TGA).

Key Issues For The Dental Industry —

Last year the TGA, the nation's regulator of therapeutic goods, changed the legal framework associated with the manufacture and importation of dental laboratory products.  These are deemed to be custom-made medical devices for regulatory purposes.

With the strong support the of the Australian Dental Industry Association (ADIA), the TGA’s reforms helped level the playing field for local manufacturers and those importing products so that they face the same regulatory obligations, particularly in respect to reporting their activities to the TGA.

The TGA’s new legal obligations provide a timeframe of two months for a local manufacturer to report the following information to the TGA:

The manufacturer’s name and business address; and
A description of the kinds of medical devices being custom-made by the manufacturer (including the device nomenclature system code for any such devices).

Similarly, an importer of a custom-made medical device must report the following information about the device to the TGA:

The their name and business address;
The manufacturer’s name and business address; and
A description of the kinds of medical devices being custom-made by the manufacturer (including the device nomenclature system code for any such devices)

The local manufacturer or importer only has to notify the TGA on one (the first) occasion if they are supplying the same kind of medical-device. A medical device is taken to be of the same kind as another medical device if they have the same Global Medical Device Nomenclature (GMDN) code, has the medical device classification and is manufactured and (where it's an issue also imported) by the same person.  For example, if you will only need to report once if you are the manufacturers or importer of dental laboratory products that are all captured under the same GMDN code (e.g. 38595: Dental crown, polymer – a device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth) and all made by the same manufacturer and all of the same device classification. 

   

TGA Online Forms —
Reporting your manufacturing / reporting activities

Local manufacturers ir importers of dental laboratory products can find out more about their legal obligations and report their activities online via the following page on the TGA's website:
www.tga.gov.au/custom-made-medical-devices

   
 

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It is important to appreciate that local dental laboratories and importers of dental laboratory products have additional legal obligations.  For example, the manufacturer of custom made devices must, at a minimum, meet conformity assessment procedures regulated by the TGA. These include conformity assessment procedures prescribed under Therapeutic Goods (Medical Devices) Regulations (Cth) 2002 that comply with the relevant "essential principles", concerning safety and performance characteristics of medical devices.  This is particularly challenging for importers of dental laboratory products as, under law, they need to be able to supply the TGA with the documentation demonstrating that the TGA's regulated safety and performance standards have been met.

Once they have supplied to the products, local manufacturers and importers also have ongoing legal obligations such as reporting any adverse events or problems; and taking corrective or preventative action, such as recalls, if necessary.

The TGA's changed reporting requirements are part of a series of legislative reforms secured by ADIA in order to create a level playing field for the dental laboratory sector by ensuring that the local laboratory sector and importers need to comply with identical legal obligations.  

Member Engagement —

On matters associated with dental product regulation the team in the ADIA national office receives advice and guidance from members serving on the ADIA-DRC Dental Regulation Committee.  Updates on the research are provided at the quarterly ADIA State Branch Briefings.  If your business has an interest in this matter, get involved today.

Further Information —

For further information from ADIA's on matters associated with dental product regulation send an email to policy@adia.org.au or telephone 1300 943 094.  To keep up to date follow ADIA on Facebook at www.facebook.com/dental.industry or subscribe to the Twitter feed @AusDental.

Currency Of Information & Disclaimer —

This update was issued on 18 May 2017 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here. 
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This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, images and where stated.

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