Transitional arrangements for the introduction of the new medical devices regulatory system
Australian medical devices guidelines
Guidance document number 9, Version 1.6
This guidance document is one of a series that has been produced to help explain the new regulatory system for medical devices in Australia that commenced on 4 October 2002. The new system has been established by the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002.
When the Australian legislation was revised in late 2002 the term "medical device" was introduced. Therefore, for the next five years, the Act will regulate medicines, therapeutic devices and medical devices. The therapeutic devices are the registered or listed entries that were in the Australian Register of Therapeutic Goods (ARTG) before 4 October 2002, or which could entered during the 5 year transition period under certain conditions. Medical devices are those products that are entered in the ARTG after 4 October 2002 under the revised legislation. The medical devices in the ARTG will be known as medical devices included in the ARTG, or more colloquially known as "inclusions".
Contents
- Introduction
- What happens to therapeutic devices and medical devices with the introduction of the new regulatory system in Australia?
- Implications for Australian manufacturers of medical devices during the transition period
- Attachment 1. Changes or variations to therapeutic devices in the ARTG - Is notification or prior approval from the TGA required?