The use of medical devices in alternative therapies
Australian medical devices guidelines
Guidance document number 7, Version 1.10
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.
Many different types of therapy regimes and techniques are used today when a person is sick, injured or unwell. These regimes and techniques include traditional western medical practices, eastern medical practices, naturopathy, reflexology, iridology, meditation and many others. Irrespective of what techniques, therapies or philosophies are utilised, if a product or object is used that meets the definition of a medical device, as stipulated in the Australian legislation, the product or object will be considered as a medical device. Consequently as medical devices they will have to comply with the requirements established by the legislation, such as the essential principles, including the advertising guidelines mentioned below, before they can be supplied in this country. Failure to do so can incur penalties stipulated in the legislation.
Contents
- Introduction
- What are alternative therapies?
- Examples of alternative therapy products
- The operation of the Therapeutic Goods Act 1989
- How are medical devices regulated?
- What schemes are in place to access unapproved medical devices?
- 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
- What is the definition of a therapeutic good?
- What is the definition of therapeutic use?
- What does supply mean?
- What is a medical device?
- How are medical devices classified?
- Who is a sponsor of a medical device?
- Who is a manufacturer of a medical device?
- What is conformity assessment?
- What are the conformity assessment procedures?
- What are the common elements in all of the conformity assessment procedures?
- What is a declaration of conformity?
- Who is responsible for the conformity assessment of a medical device and the declaration of conformity?
- Choice of conformity assessment procedures and the relevant declaration of conformity
- What are the special conformity assessment procedures?
- What are the essential principles?
- How do standards relate to the essential principles?
- Advertising requirements
- Responsibilities and obligations under the Therapeutic Goods Act 1989
- Once a medical device has been approved for supply, what systems are in place for detecting and reporting problems?
- Offences, penalties and cancellations
- Enforcement
- Recalls of therapeutic goods
- Non-Recall actions