Medical device consultancy in Australia calls for a close understanding of guidelines of ARGMD. It clearly underlines the information to be supplied with applications to import, export, manufacture and supply medical equipment (devices) in Australia.
The Therapeutic Goods Administration (TGA) is the competent authority for overall quality and maintenance check of medical equipment in Australia. They are divided into five classes; class I, IIa, IIb, III and Active Implantable Medical devices (AIMD). In vitro-diagnostic devices (IVDs) are divided into four different classes; class I, II, III and IV. The sponsor is responsible for registering the medical equipment (device), and all activities concerning them while manufacturers have obligations to fulfill the requirements. The country specific regulatory services in Australia may include:
1 Medical Device Specific regulation strategy reports in Australia,
2 Medical Device Registration with the TGA,
3 Australia Sponsor Representation for Medical Device manufacturers and TGA Technical documents Preparation and
4 Consultant specific unique line of products
Sponsor is the company that bears the responsibility for the supply of a medical equipment in or from Australia. The sponsor's name and address is generally mentioned on the label.
Manufacturers take complete responsibility for the design and production of a device in case they make the device themselves or subcontract some of these activities. The name and address of the manufacturer appears on the device label mandatorily. For any medical equipment to be supplied in Australia, the device needs to be mandatorily included in the Australian Register of Therapeutic Goods (ARTG) that is regulated by the Australian Therapeutic Goods Administration (TGA). As per TGA medical equipment (devices) are those that are used on humans, used for therapeutic benefits, in most cases have a physical or mechanical effect on the body or are utilized to measure or monitor functions of the body. They can range from a bandage that is put on a scratch to lifesaving equipment such as pacemakers that are implanted in human body.
Additional examples of medical equipment (device) may include:
1 artificial hips
2 blood pressure monitors
3 breast implants
6 lubricating eye drops
7 MRI scanners
8 Orthodontics - e.g.,braces, fillings
10 tongue depressors
All medical equipment to be marketed in Australia needs to meet the requirements which are underlined in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002.
The Australian Regulatory Guidelines for Medical Devices (ARGMD) has been developed to:
1 provide guidance to assist manufacturers and sponsors of medical equipment (devices) in meeting the regulatory requirements for legally supplying a medical equipment (devices) in Australia
2 help ensure that medical component applications to the TGA meet all the necessary legislative requirements so that applications are processed with minimal delays
3 enhance the clarity and transparency of the processes:
-leading to the legal supply of medical devices in Australia
-for meeting the ongoing requirements once a device is available for supply in Australia.
Scope of the ARGMD
The ARGMD is a consolidated reference document detailing the regulatory requirements for medical devices in Australia.
The ARGMD describes the information to be supplied with applications to:
4 supply medical devices in Australia.