Australian Regulation of Medical Devices - is there a better way?

The Australian Senate Community Affairs Committee has established an inquiry into the regulatory standards for approval of medical devices. The terms of reference include the role of the TGA and the processes of regulation in Australia (both pre- and post-market) and there is a particular focus on orthopaedic implants.

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TGA Announces Major Devices Regulatory Reforms

• Introduction of Third Party Conformity Assessment
• Reclassification of Orthopaedic Joints
• All Class III and AIMD implants to require TGA assessment
• All Class IIb implants subject to application audits

TGA have today announced some long anticipated and far reaching reforms to the Australian Conformity Assessment of Medical Devices.  These reforms have resulted from a series of reviews into the level of regulatory assessment in Australia and particular disquiet with the unequal treatment of Australian manufacturers – who are currently required to be directly regulated by TGA for devices of all classes, whereas overseas manufacturers may gain TGA approvals by means of recognition of CE certifications.

The reforms are intended to achieve three principle aims:

Reclassification of Orthopaedic Joints to align with Europe

This follows the European up-classification all Orthopaedic Joint Implants to Class III.  The sting in the tail is that TGA specifically includes Partial joints as Class III, whereas the revisions to MDD specifically apply to Total Joint Prostheses and can be interpreted to allow IIb classification for partial joint prostheses.  This may mean that some devices classified IIb in Europe will now be Class III in Australia and subject to higher review requirements in Australia.

Equal Treatment of Australian and International Manufacturers

The requirements for Australian manufacturers to be subjected to separate Australian TGA assessment, even if they also hold CE mark has been a long standing source of frustration.  These proposed reforms make two changes which will result in completely equal treatment for Australian manufacturers.

• Third Party Conformity Assessment
• Class III implants and Active Implantables (AIMDs) will now be required to have TGA conformity Assessment

Increased rigour of review for high risk implants

The  requirement for Direct TGA review of Class III implants and AIMDs plus a new requirement for a TGA application audit (a desktop review of key Technical File Data) for Class IIb will see an increased level of scrutiny of implantable devices.  This is a response the Australian Health Technology Assessment Review  which called for increased regulation of high risk devices.

We will be writing to you again with a more detailed analysis of the proposed reforms and the outcomes of the consultation process which will take place over the next 6 weeks.  Details of the reform package are available at http://tga.gov.au/devices/consult/cons-devices-reforms.htm. Meanwhile if you have particular questions – please feel free to contact us directly.

Arthur Brandwood

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BRANDWOOD : BIOMEDICAL

Securing Your Compliance

Suite 4.08,   460 Pacific Highway
St Leonards NSW 2065 Australia

Enquiries@brandwoodbiomedical.com.au

New Australian IVD Regulations start July 1. Are you ready?

After protracted consultations, negotiations and rescheduling, the new Australian IVD regulatory framework commenced on July 1st 2010.  Most IVDs were previously exempt from pre-market approval requirements, but the new system intends to provide regulation for all IVDs.  New IVD products introduced after the commencement date will need to be included on the ARTG by means of a formal application to TGA.   

For devices already on the market before 1st July, a four-year transition period will apply for manufacturers to obtain inclusion on the ARTG.  IVDs introduced on or after 1 July will need ARTG inclusion before they can be supplied.  Do you have an IVD close to market?   Acting before July 1 may buy you four years to upgrade your systems and compliance.   Time is running out for this critical regulatory decision.  Contact us  for more advice on establishing market precedent.

For detailed reviews of the new regulations see the following recently published articles by Brandwood Biomedical Senior Consultant Paul Cohen:

• The changing regulatory environment of in vitro diagnostics: implications for sponsors, manufacturers and laboratory users (published in Australian Journal of Medical Science)

• Personalised Medicine – Navigating Dx/Rx Co- development (published in Australasian Biotechnology, AusBioTech). 

Poor compliance of Class 1 medical devices - TGA crackdown coming?

Recent figures reported by TGA showed that random application audits found 40% of Class I ARTG entries were invalid, leading to cancellation of the ARTG approvals.  Although the availability of direct electronic entry to ARTG for Class I devices is not currently under threat, TGA are currently looking for ways to improve compliance.  Expect more refined targeting mechanisms, and mandatory audits for serial offenders. 

Are you preparing a Class I device submission?  Contact us for advice on ensuring your compliance and so you can submit your entry to ARTG with confidence.

Or perhaps in 2010...

TGA appears to have postponed implementation of the new IVD regulations into 2010.  This follows considerable difficulty with establishing a mechanism for dealing with the large bulk of IVDs used in Australia which are imported.  There's no equivalent of the CE certificate availabe for most of these devices - as the proposed TGA system captures many IVDs which are self certified in Europe.

For more information - come along to the IVds session at Ausbiotech 2009 to hear about the latest developments in Australia and internationally in IVD regulations.  Click here to download the full conference program.