An overview of the new medical devices regulatory system
Australian medical devices guidelines
Guidance document number 1, 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.
Contents
- Introduction
- What is a medical device?
- How are medical devices regulated?
- Structure of the revised Therapeutic Goods Act 1989
- Are all medical devices covered by the new legislation?
- The Australian Register of Therapeutic Goods
- Transition period
- Fees and charges
- How are medical devices classified?
- How does classification relate to conformity assessment?
- Who is responsible for the conformity assessment of a medical device?
- What are the essential principles?
- How do standards relate to the essential principles?
- Once a medical device has been approved for supply, what systems are in place for detecting and reporting problems?
- What schemes are in place to access unapproved medical devices?
- Offences, penalties and cancellations
- Enforcement