Transition of listed and registered devices
Fact sheet no. 10
1. What is meant by the transition of listed and registered medical devices?
The medical devices legislation introduced in October 2002 allowed a five year transition period for previously supplied devices to comply with the new legislative requirements.
2. What happens if devices do not transition?
Medical devices that do not comply with these new requirements by 4 October 2007 will be automatically cancelled from the Australian Register of Therapeutic Goods and cannot be lawfully supplied in Australia until such time as they do comply.
3. Can the transition be a notification?
The legislative requirements for medical devices are very different to those that existed when the device was listed or registered and so it will be necessary to:
- Register and have the manufacturers certificates accepted;
- Submit an application to have the medical device assessed against the new requirements and included on the Australian Register of Therapeutic Goods.
Note: Once the device has been included on the ARTG, instruct the TGA to cancel the old listing or registration so as to avoid a duplication of the annual charge.
4. What about medical devices that require conformity assessment before they can transition
A small number of medical devices will need to undergo Conformity Assessment by the TGA before they can be included on the ARTG as medical devices. This may involve auditing the manufacturer and an assessment of the safety and performance of the device.
Medical devices that require conformity assessment include:
- Devices manufactured in Australia (other than those that are classified as non sterile class 1 medical device and do not have a measuring function.
- Devices containing tissues of animal origin, or tissues, cells or substances of microbial or recombinant origin.
- Medical devices that contain as an integral part, a medicine that has an action ancillary to that of the device.
- Medical devices incorporating stable human blood or human plasma that is liable to act in a manner ancillary to the device.
Note: The manufacturer is responsible for applying for and undergoing conformity assessment. Further information regarding conformity assessments may be found in the guidance document Conformity assessment procedures <http://www.tga.gov.au/docs/html/devguid3.htm>.
5. The steps to transition
I. Contact the manufacturer and obtain ...
- An original or properly notarised copy of the current manufacturer's evidence. This needs to be:
- A Certificate issued by a Notified Body, under the Medical Device Directive 93/42/EEC, or
- A certificate issued against the Active Implantable Medical Devices Directive 90/385/EEC, or
- A certificate issued by the TGA under the Therapeutic Goods (Medical Devices) regulations 2002, or
- A certificate issued against the EU-Australia Mutual Recognition Agreement.
- The classification of the device as per the Australian Classification Rules- Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.
- The GMDN Code for the device
Note: It is recommended sponsors obtain, a copy of the Australian Declaration of Conformity from the manufacturer to confirm the details identified above prior to submitting the manufacturers' evidence.
Please refer to Guidance document number 5, "The declaration of conformity" <http://www.tga.gov.au/docs/html/devguid5.htm>.
II. Establish an e-business account
Applications for inclusion onto the ARTG are submitted across the web through the Device Electronic Application Lodgement (DEAL) system. Access to most areas of this e-business site is restricted by a password. New users to the DEAL system can establish an e-business account at the SIME homepage www.tgasime.health.gov.au/sime/home.nsf.
Click on the New User section of the page and down load the file user form.zip. This contains the instructions for completing the following forms:
- Client Details Form - only needed for new sponsors who do not have a CLIENT identification number. For first time sponsors, the form needs to be completed for both the sponsor and the overseas manufacturer.
- E Business Access to establish an e-business account with the TGA and to obtain an account name and password.
Complete these forms and fax them to the TGA on 02 6232 8581. An account name and password will be sent to the e-mail address specified on the form within a couple of days.
If you have any further queries with regard to the completion of these forms, contact the TGA Online Services Team on 1800 010 624 or tga.sime@tga.gov.au.
III. Complete a DEAL application
Step 1 - Logging on to DEAL
An application to include a device on to the ARTG is submitted via the TGA e-business website www.tgasime.health.gov.au. Click on Medical Devices on the home page. Proceeding beyond this point requires entry of a user name and password. Both account names and passwords are case sensitive.
Tip: Cut and paste your password from your notification email to the DEAL website.
Step 2 - User Instructions
Once logged on, the user will be taken to the DEAL front page, which will provide a number of options. Download and print a copy of the user instructions for DEAL by clicking on the User Documentation button on the right hand side of the screen. This document will give valuable information and assist you to navigate through the various options available in DEAL.
Step 3 - Submitting manufacturers evidence
The manufacturer's evidence must be submitted to the TGA for all medical devices classified as a class 1 (that are supplied sterile or have a measuring function), Class IIa, IIb, III or Active Implantable Device (AIMD).
Manufacturers' evidence is not required for class 1 medical devices that are not supplied sterile or do not have measuring function.
To register the manufacturer's evidence, Select Register a manufacturer's Evidence on the DEAL front page and follow the prompts.
The certificate, which may or may not have an attached schedule, must indicate the scope of the devices covered and should have an expiry date. If there is no expiry date, DEAL will automatically set the expiry as five years from the issue date of the certificate.
For further assistance refer to the fact sheet on Manufacturers evidence - EC Certificates <http://www.tga.gov.au/devices/fs_eccert.htm>.
Note: The manufacturer's evidence must be accepted before commencing step 4.
Step 4 - Including a device on the ARTG
To include a medical device on the ARTG, select Create a Medical Device Application on the DEAL home page. All the information needed to complete this step should be available from a manufacturer's Australian Declaration of Conformity for the medical device.
Note: Read the declaration at the end of the electronic form before submitting the application for the inclusion of the medical device.
Note: The manufacturers intended purpose for the device should be provided by the manufacturer and should be in agreement with the instructions for use and the definition associated with the selected GMDN Code.
Step 5 - Application audits
Applications to include a type of medical device may be randomly selected for an application audit. It is intended that 5-10% of applications will be audited. There will be no fee associated with these randomly selected applications.
Applications for certain types of devices will automatically be selected for an application audit and may incur a further fee. A list of these types of devices can be found at the website indicated below, and in the Therapeutic Goods (Medical Devices) Regulations 2002, Regulation 5.3).
These audits are carried out once the TGA receives the application and prior to inclusion on the ARTG. If an application has been identified for an audit, the sponsor will need to provide further documentation to support the application. For further help with application audits please refer to the guidance document Application Audits <http://www.tga.gov.au/docs/html/devguid2.htm>.
Disclaimer
This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.
Further information
The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the Therapeutic Goods Administration (TGA) can be contacted by:
Telephone: 1800 141 144
Facsimile: 02 6232 8299
Email: cab.medical.device.information@tga.gov.au
Website: http://www.tga.gov.au/devices/devices.htm
Mail: PO Box 100, Woden ACT 2606
© Commonwealth of Australia 2006