Australia: Australia's medical devices regulatory framework is set for change, TGA consultations underway

Last Updated: 30 November 2016
Article by Marie Feltham
Industry Focus: Life Sciences & Healthcare

What you need to know

  • Following the release of the Federal Government's response to the Expert Review of Medicines and Medical Devices Regulation, the Therapeutic Goods Administration (TGA) has begun its consultation on the reforms to Australia's framework for medical device registration.
  • The changes to the regulatory regime will see current pathways for medical device registration remain, and three new pathways will also be added.
  • Those who want to have a say in shaping the regulatory framework can participate in the TGA's consultation process, which will run between now and March 2017.

It has now been two months since the Federal Government released its response to the Expert Review of Medicines and Medical Devices Regulation, also known as the Sansom Review. The Sansom Review was tasked with reviewing Australia's medicines and medical devices regulatory framework and processes to identify opportunities for improvement.

With the Federal Government having supported most of the recommendations emerging from the Sansom Review, the Therapeutic Goods Administration's (TGA's) consultation process on the implementation of the Government's response is now getting underway.

Here is a quick recap of current regulations governing the registration of medical devices in Australia, the proposed reforms and issues for implementation.

What is the current regulatory framework for medical device registration?

At the moment, there are two pathways by which a medical device may be included in the Australian Register of Therapeutic Goods (ARTG). Medical devices are registered on the basis of conformity assessment certificates obtained by manufacturers in the following ways:

Pathway One Pathway Two
The TGA undertakes conformity assessment and issues the certificate.

An EU notified body undertakes the assessment and issues a device with a CE mark (which indicates that the device meets all EU requirements), and the TGA uses this assessment to determine whether the device should be included on the ARTG.

The TGA conducts application audits to mitigate the risk of poor quality conformity assessments conducted by some EU notified bodies.

What are the main changes?

The current pathways for registration will continue and there will be three new pathways (marked in bold below):

Pathway One Pathway Two Pathway Three

Pathway One will involve conformity assessment occurring within Australia by either:

  1. The TGA
  2. or

  3. A commercial body (such as an Australian affiliate of a European notified body, or an independent organisation) designated by the TGA to undertake conformity assessments of medical devices for the Australian market (and the TGA will not conduct application audits for devices certified by these bodies).

Pathway Two will involve utilising approvals in overseas markets in circumstances where:

  1. The TGA accepts conformity assessment undertaken by an EU notified body and determines whether a device should be included in the ARTG (and it is expected that with time, as confidence in EU notified bodies grows, fewer application audits by the TGA will be required)
  2. or

  3. The device has been approved by a comparable overseas regulator.

Pathway Three will involve expedited approval of 'novel' medical devices.

Pathway Three will be available to products which demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions, and a significant advance over those products already included in the ARTG.

What needs to happen for the changes to be implemented?

A number of measures will need to be taken to give effect to these reforms. These include:

  • Legal and administrative arrangements to support the designation by the TGA of bodies to undertake conformity assessments of medical devices
  • In consultation with healthcare consumers, health professionals and industry, criteria and standards will need to be developed:
    • to designate suitably qualified bodies within Australia to undertake conformity assessments, including standards in areas of technical and clinical competence and governance (including management of conflict of interest) (Pathway 1B)
    • for identifying comparable overseas regulators (Pathway 2B)
    • to determine which devices will be accepted into expedited review (Pathway 3).

When will the changes come into effect?

The TGA will roll out these reforms progressively over the next 18 – 24 months.

What recommended reforms were not accepted by Government?

The Expert Panel Review recommended that a registry should be established to capture information about patients and procedures involving all high-risk implantable devices. However, the Government deferred consideration of this recommendation and determined that further consultation was needed to assess how such registries could be managed and funded in the future, the risks and benefits of establishing registries, and appropriate mechanisms to enable access to data.

What's next?

These will be significant reforms which should align the Australian regulation of medical devices with international developments. More pathways to registration should reduce the burden and cost for industry and make new medical devices available to patients more quickly.

The TGA will now need to flesh out the detail of the new pathways. Between now and March 2017 the TGA will run consultations on:

  • the designation of Australian conformity assessment bodies for medical devices
  • accelerated assessment of medical devices
  • use of overseas regulatory approvals for medical devices and criteria for identifying comparable overseas designating authorities and regulators.

These consultations present an important opportunity for industry to become involved in shaping the regulatory framework for the future.

The first two consultation papers have now been released for comment by the TGA, and comments close on 11 January 2017. Further information about the TGA's consultation process is available at: https://www.tga.gov.au/implementation-reforms-public-consultation-forecast.

This article is intended to provide commentary and general information. It should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this article. Authors listed may not be admitted in all states and territories

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Mondaq Advice Centre (MACs)
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.