Obligations and responsibilities of medical device sponsors and manufacturers
Australian medical devices guidelines
Guidance document number 20, 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.
Under the Therapeutic Goods Act 1989 sponsors and manufacturers of medical devices have separate yet inter-linked responsibilities and obligations. The differences and similarities need to be clearly understood. This is especially important for medical device manufacturers. If someone carries out activities that would normally be carried by a manufacturer, they would then be considered as a manufacturer. This also refers to rewording or fabricating statements or declarations that should be made by manufacturers about their products, including the intended purpose of use, any instructions, labelling or advertising.
Contents
- Introduction
- Responsibilities and obligations under the Therapeutic Goods Act 1989
- Responsibilities of sponsors and applicants for inclusion of a medical device in the ARTG
- Requirements and obligations for manufacturers of medical devices
- Technical documentation for medical devices
- Product description
- Technical requirements
- Design
- Applications for a conformity assessment certificate issued by the TGA
- Manufacturers who have been issued a conformity assessment certificate by the TGA
- Conformity assessment procedures for overseas manufacturers who do not have an Australian conformity assessment certificate