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

News

TGA 'Meeting Your Obligations' Workshop in Adelaide to Assist SMEs

TGA 'Meeting Your Obligations' Workshop in Adelaide to Assist SMEs

30th Jan 19

Summary —

The Therapeutic Goods Administration’s (TGA) SME Assist is holding a ‘Meeting Your Obligations’ workshop in Adelaide on Thursday, 14 February 2019.

Key issues for the dental industry —

SME Assist, together with Flinders University and the Medical Device Partnering Program, presents the free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation. This may include:

  ■ Small to medium enterprises (SMEs);
■ Start-ups; and/or
■ Researchers.


If you are making therapeutic claims about a product or have a product that is likely to be considered a therapeutic good, this workshop will help you understand your responsibilities at different stages of the regulation process.

The workshop will cover:

 

■ Basics – An overview of therapeutic goods regulation, including the TGA’s role, market authorisation, and helpful links for applications;
■ Case studies – Covering common concepts such as advertising and adverse events;
■ Q&A with TGA specialists; and
■ Product focus (subject to demand) – Sessions that focus on different specialty areas. Options are provided when registering for the workshop.

Event details:

  Thursday, 14 February 2019, 9:00am – 2:30pm
Flinders University at Tonsley, Theatre 2
1284 South Road, Tonsley SA 5042


To register your interest for this event please click on the following link:

  ‘Meeting Your Obligations’ workshop (Adelaide)


Member Engagement — 

The ADIA Policy Team receives advice and guidance in relation to therapeutic goods regulation from members serving on the ADIA-TCPC Trade & Commercial Policy Committee.

Further information —

To keep up to date with all matters associated with dental product regulation follow ADIA on Facebook at www.facebook.com/dental.industry or the Twitter feed @AusDental. For further information on ADIA's engagement with the TGA send an email to policy@adia.org.au or telephone 1300 943 093.

Currency & Disclaimer —

This update was issued on 30 January 2019 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. 


This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated. 

A.. A D I A . .S T R A T E G I C . .A L L I A N C E S

 

Dental Industry News

  • TGA Publishes Draft Advertising Guidance

    15th Aug 18

    The dental industry is playing a lead role in supporting the TGA develop industry guidance on the 2018 TGA Therapeutic Goods Advertising Code, a document that sets clear standards for advertising medical devices to consumers. More

  • Patient Implant Cards - A 19th Century Reform

    1st Feb 18

    Thanks to ADIA's advocacy, the dental industry looks set to escape a proposed TGA reform that would require patient information 'cards' to be provided to patients, a reform that ignores advances in electronic patient records. More