Class 1 medical devices
Fact sheet no. 19
October 2006
1. What are Class 1 medical devices?
Class I devices are the lowest risk classification. The Class is determined by a set of rules and for example are intended for:
- external use
- may rely on an energy source other than the body or gravity, if not used for diagnosis or therapy,
- does not deliver energy to the body,
- does not deal with material introduced into the body or that comes in contact with injured skin; or
- continuous use less than 60 minutes in a body orifice or stoma; or
- continuous use less than 30 days in the oral cavity, ear canal or nasal cavity, or are:
- reusable surgical instruments; or
- medical devices for export only.
For further help please refer to the guidance document "Classification of Medical Devices" <http://www.tga.gov.au/docs/html/devguid25.htm>.
2. Kinds of medical devices
Class I devices are considered to be of the same kind if they have the same sponsor, manufacturer and GMDN Code. One kind of medical device means one inclusion on the Australian Register of Therapeutic Goods (ARTG).
3. GMDN Codes
The Global Medical Device Nomenclature (GMDN) is a collection of terms with a unique code number that describes devices. The GMDN structure consists of three levels:
- Twelve categories of devices
- Template terms (generic device groups), and
- Preferred terms (product types).
Template terms group similar preferred terms Eg: Scissors. Class I devices are included on the ARTG by the template term and its 5 digit code number.
Preferred terms represent types of devices that have the same or similar intended purpose: Eg; scissors suture. Class I devices that are supplied sterile or have a measuring function are included on the ARTG by the preferred term.
A synonym is a common term that cross-references to a preferred term. When a synonym is selected, the Device Electronic Application Lodgement (DEAL) system will default to the preferred term or the appropriate template term.
Manufacturers are best placed to identify the correct GMDN Code and sponsors are urged to seek advice from the manufacturer and their Declaration of Conformity to ensure the GMDN Code is correct. For further help please refer to the fact sheet "Using GMDN Codes" <http://www.tga.gov.au/devices/fs_gmdn.htm>.
4. Inclusion on the ARTG
The ARTG is a database of all therapeutic goods accepted for supply in Australia. All devices must be included on this database by the Australian sponsor prior to supply in Australia. The ARTG can be viewed at www.ebs.tga.gov.au.
5. DEAL
Applications for inclusion onto the ARTG are submitted across the web through the DEAL system. Access to most areas of this e-business site is restricted by a password.
6. Establishing an e-business account
New users to the DEAL system can establish an e-business account at the TGA eBusiness Services website www.ebs.tga.gov.au.
Click on the New User section of the page and download 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 Form 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.
7. Completing a DEAL application
Step 1 - Obtaining Certificates
Obtain, from the manufacturer, a copy of the Australian Declaration of Conformity and, for Class I devices supplied sterile or those with a measuring function, also obtain a relevant Conformity Assessment Certificate (including any schedules that may be attached).
Step 2 - Logging on
An application to include a device on to the ARTG is submitted via the TGA eBusiness Services website www.ebs.tga.gov.au. Click on eBS Access Forms on the home page to initiate a request for an account name and password. Both account names and passwords are case sensitive.
Step 3 - User instructions
Once logged on, the user will be taken to the DEAL home 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 4 - (Class I sterile or measuring)
Evidence of the Manufacturer's Conformity Assessment Certification needs to be established and registered with the TGA for Class I devices that are supplied sterile or have a measuring function.
The Conformity Assessment Certificate needs to be a Certificate issued by a Notified Body, under the Medical Device Directive 93/42/EEC, or issued by the TGA under the Therapeutic Goods (Medical Devices) Regulations.
To register the Manufacturers Conformity Assessment Certificate', select Register a Manufacturer's Evidence on the DEAL home 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 help with acceptable evidence please refer to the guidance document "Conformity Assessment Procedures" <http://www.tga.gov.au/docs/html/devguid3.htm>.
NB Manufacturer's evidence must be approved before commencing step 5.
Step 5 - Including a device on to 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.
NB Please read the declaration and ensure you can comply with what is required before agreeing and submitting the application.
NB The intended purpose should be as per the instructions for use and the GMDN Code.
8. Application audits
Applications to include Class I medical devices on the ARTG may be randomly selected for an application audit. 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>.
9. Processing times for an application
The processing times vary depending on the number of applications being processed at any one time, the risk classification of the device and whether the application is to undergo an audit. If an application is selected for audit, a sponsor will be given 20 days to provide the required documentation.
The sponsor will receive a letter advising that a application has been selected for audit and outlining the requirements for the audit.
10. Fees and charges (as of July 2004)
The fees for including Class I devices on the ARTG are:
- Class I medical device- sterile - $670
- Class I medical device - measuring - $670
- All other Class I medical devices - NIL
The annual charge for Class I medical devices sterile and measuring is $670 and for all other Class I devices it is $50.
11. Advertising
It is a condition of inclusion on the ARTG that advertisements for devices are consistent with the intended purpose on the ARTG. Advertisements for devices must comply with the Therapeutic Goods Advertising Code and copies are available from the Therapeutic Goods Advertising Code Council website at www.tgacc.com.au.
12. Post market activities
There are three major areas of postmarket activity. The sponsor of the medical device has a role to play in each of them. The components are:
- The manufacturer's Post-market Surveillance system,
- Post-market monitoring of compliance by the TGA, and
- Vigilance.
Post-market surveillance are both pro-active and reactive activities that the manufacturer undertakes to gather information about device performance in the market. These might include clinical trials, customer surveys and the investigation of customer complaints.
Post-market monitoring of compliance includes, product reviews, manufacturing site audits, and product testing by the TGA.
Post-market vigilance relates to the reporting and investigation of adverse events associated with the use of medical devices. The TGA unit responsible for receiving and investigating adverse event reports is the Incident Report and Investigation Scheme (IRIS).
Post-market vigilance and surveillance is an obligation on the manufacturer. However the Australian Sponsor is the responsible legal entity and must participate in the system. For further help please refer to the guidance document "Post market activities". <http://www.tga.gov.au/docs/html/devguid11.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 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