TGA Announces Major Devices Regulatory Reforms
Wednesday, November 3, 2010 at 5:00PM - 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
BRANDWOOD : BIOMEDICAL
Securing Your Compliance
Suite 4.08, 460 Pacific Highway
St Leonards NSW 2065 Australia
Enquiries@brandwoodbiomedical.com.au
