Important information for users and purchasers of medical devices
29 October 2007
Thursday 4 October 2007 marked the end of a five year transition period to a new medical device regulatory framework.
An important feature of the new regulatory framework was the need for all devices supplied commercially in Australian prior to 4 October 2002 to transfer to the new framework and meet current internationally accepted requirements for quality, safety and performance of medical devices. Sponsors of such products had until midnight 3 October 2007 to lodge an application with the TGA to transition their product to the new framework in order for them to continue to supply those products into the future.
The TGA has worked very closely with the devices industry and Australian sponsors over five years, and particularly so over the last two years, to ensure that sponsors were aware of the deadline and the need to transition their products. The TGA has also worked with the States and Territories through the National Coordinating Committee on Therapeutic Goods (NCCTG) to help purchasing authorities and hospitals assess the continued availability of products identified as pivotal to the provision of health services in the various jurisdictions.
It is, however, inevitable that some sponsors (also known as suppliers) may have used the transition deadline to rationalise their product lines and discontinue some of their devices. Discontinued devices will remain available in the supply chain until such time as stocks remaining outside the direct control of the sponsor (such as this held by distributors and central stores in hospitals) are exhausted. This has given users and purchasers of medical devices time to identify other available devices and to organise alternative supplies.
Please note: This will not affect listed and registered therapeutic devices which are not subject to the regulatory framework for medical devices. These devices include:
- household, commercial and hospital grade disinfectants (but not sterilants or instrument grade disinfectants which are regulated as medical devices)
- In-vitro diagnostic devices
- menstrual tampons
- devices containing materials of human origin or viable animal origin
- antiseptic swabs, brushes and applicators with antiseptic claims that are to be transferred to listed or registered medicines
Other products previously listed as medical devices which are to be transitioned to that part of the Register for medicines.
Where a product is not being transitioned by the supplier, you can:
- ask the supplier to identify alternative devices for you; or
- contact the TGA information line on 1800 141 144. The TGA can identify sponsors of alternative products on the Register for you to contact to see if those products meet your service delivery needs.
What if there are no alternative products commercially available?
The TGA operates compassionate use programs which allow patients with serious clinical need to access (through their treating medical practitioner) products not included in the Register. One such program is the Special Access Scheme (SAS) which accommodates the treatment of individual patients.
The operation of the SAS is outlined in a suite of Special Access Scheme <http://www.tga.gov.au/hp/sas.htm> documents available on the TGA website.
The documents available include:
- an 'At a glance' document;
- a 'Frequently asked questions' document;
- a detailed guidance document titled Access to Unapproved Therapeutic Goods - the Special Access Scheme; and
- copies of the SAS forms.
The TGA also operates the Authorised Prescriber mechanism. This scheme can be utilised where it is administratively burdensome for a medical practitioner to obtain approvals to supply a product on a patient-by-patient basis - such as where the practitioner is treating a large number of patients with the same clinical condition. Under this scheme a practitioner is able to obtain a single approval from the TGA to treat all patients under his/her direct care who suffer from a specified medical condition.
The operation of the Authorised Prescriber <http://www.tga.gov.au/hp/ap.htm> is outlined in a suite of documents similar to those available for the SAS.