Regulatory Requirements: The Basic Information for Australian Medical Device Manufacturers

To manufacture and sell a medical device in Australia, you must hold certification from the Therapeutic Goods Administration (TGA). Depending on the risk level of the device you manufacture, requirements can vary significantly. Read on to learn key information for device manufacturers.

 Is it a medical device?

There’s no better way to start than reviewing the medical device definition to justify and confirm whether your product is in fact a medical device. The definition below is taken from the Therapeutic Goods Act 1989 (41BD).

A medical device is:

a. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

i. diagnosis, prevention, monitoring, treatment or alleviation of disease;

ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;

iii. investigation, replacement or modification of the anatomy or of a physiological process;

iv. control of conception;

v. and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

aa. any instrument, apparatus, appliance, material or other article specified under subsection (2A); or

ab. any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or

b. an accessory to such an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).

 Are you considered to be a Manufacturer by the TGA?

Although it doesn’t seem to be a difficult question, your definition of ‘manufacturing’ may be very different from the TGA’s. So we’ve given the TGA’s definition below, again taken from the Therapeutic Goods Act 1989 (41BG).

1. The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person’s name, whether or not it is the person, or another person acting on the person’s behalf, who carries out those operations.

2. If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person’s name, does one or more of the following using ready made products:

a. assembles the device;

b. packages the device;

c. processes the device;

d. fully refurbishes the device;

e. labels the device;

f. assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:

i. the labelling on the device;

ii. the instructions for using the device;

iii. any advertising material relating to the device;

iv. technical documentation describing the mechanism of the device.

3. However, a person is not the manufacturer of a medical device if:

a. the person assembles or adapts the device for an individual patient; and

b. the device has already been supplied by another person; and

c. the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:

i. the labelling on the device;

ii. the instructions for using the device;

iii. any advertising material relating to the device.

iv. technical documentation describing the mechanism of action of the device

4. A person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations for the purposes of this subsection.

 The Next Step

It is the responsibility of a manufacturer to decide, justify, and confirm the classification of a medical device. Correct classification is vital because it decides the regulatory routes available to for conformity assessment and importantly gaining access to the Australian market.

Use the classification rules and explanatory notes given in the Australian Regulatory Guidelines for Medical Devices (ARGMD) or contact KD&A for further assistance.

Class I Medical Device Manufacturers   

Australian manufacturers of Class I medical devices (not including Class I Sterile and Class I measuring devices) must complete the following to gain market access:

• Compile and maintain a Technical Documentation for the device
• Complete product registration for a Class I medical device to obtain an Australian Register for Therapeutic Goods (ARTG) inclusion.
• Hold a post market surveillance system and monitor the product once on the Australian market. This includes product traceability and adverse event reporting.

The TGA do not review documentation unless an application audit or post market random review of completed.

Other (I measuring, Class I sterile, Class IIa, Class IIb, and Class III and AIMD) Manufacturers

Australian manufacturers of I measuring, Class I sterile, Class IIa, Class IIb, and Class III and AIMD devices must complete the following to gain market access

• Complete a TGA Conformity Assessment Application
• Develop, implement and maintain a QMS (including post market surveillance procedures)
• Compile and maintain a Technical Documentation for the device
• Undergo TGA certification and ongoing surveillance audits
• Complete product registration for the applicable device class to obtain an Australian Register for Therapeutic Goods (ARTG) inclusion.

A Few Important Hints

Ensure you have a Regulatory Strategy in place

Understand the best regulatory routes available to you, be prepared for any regulatory hurdles, and know the expected costs associated with your project.

Don’t forget the ARTG inclusion

It is a significant achievement for any device manufacturer to obtain TGA conformity assessment but it isn’t the final step. Ensure a device application and ARTG inclusion are complete prior to placing your product on the market.

Check other regulatory requirements before placing your product on the market

Such as the Therapeutic Goods Advertising Code 2002

Maintain your company’s Quality Management System

A QMS is a big task, managing it can be daunting. Ensure you stay on top of the day to day activities required. KD&A can assist your company to create a user friendly QMS which we can also help to maintain if you need.

Ask for help when you need it

An expert can provide you with all the guidance and assistance you need to navigate the TGA process. Let KD&A help you avoid costly mistakes which can hold up your time to market, contact us for a personalised quotation.

If this all looks too hard….KD&A are here to help. We are TGA experts and have the insight of previously being a device manufacturer. We’ll simplify the process for you, resulting in less nasty surprises and a smoother and more efficient path to market.  Contact us, we’d love to hear from you.

To learn more about KD&A’s services go to our services pages, or visit the clients page to hear about their experiences.