Australian Medical Devices Guidance Document Number 25 - Classification of Medical Devices

by Jonathan Hunt,Omnex Inc published on January 12, 2005


This guidance document is one of a series produced to assist a wide-ranging audience to understand the regulatory system for medical devices in Australia that commenced on 4 October 2002. The system has been established by the Therapeutic Goods Act, 1989 and the Therapeutic Goods (Medical Devices) Regulations, 2002. Although each guidance document has been developed to provide information about particular aspect of the medical devices regulatory system in Australia, it is expected that a certain amount of cross-referencing to other documents in the series will be inevitable.


The purpose of this document is to provide guidance on the classification rules for medical devices

and relates to the following segments of the medical device legislation.

• Section 41BD of the Therapeutic Goods Act 1989 (the Act)

• Regulation 3.2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (MD


• Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.

• Dictionary – Therapeutic Goods (Medical Devices) Regulations 2002.


The risks associated with using medical devices can range from little or no risk to patients and users to significant potential risks inherent in the type of device. The level of premarket intervention by the regulator is proportional to the level of potential risk and is established through a classification system based on that potential risk. The classification risk is determined from:

  • the manufacturer’s intended purpose for the medical device, and
  • a set of classification rules. These rules will classify medical devices into one of five classes of medical devices

To Know More, Download this article by Australian Government, Department of Health and Ageing Therapeutic Goods Administration

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