Conditions on conformity assessment certificates issued by the Therapeutic Goods Administration
Australian medical devices guidelines
Guidance document number 12, 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.
A manufacturer, either in Australia or elsewhere, uses conformity assessment procedures to demonstrate that a medical device conforms to the essential principles of safety and performance specified in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002. Depending on the procedure chosen, assessment of the final design, the controls implemented for production and the manufacturer's courses of action, an audit and assessment by the TGA may be required. If this is required and the inspection is successful, the TGA will issue a conformity assessment certificate to the manufacturer.
Contents
- Introduction
- Conditions imposed when a conformity assessment certificate is issued
- Automatic conditions on a conformity assessment certificate
- Entry and inspection powers
- Review requirements
- Notification of substantial changes
- Payment of fees
- Conditions that may be imposed when conformity assessment certificates are issued
- Conditions imposed after a conformity assessment certificate has been issued
- Automatic conditions on a conformity assessment certificate
- Suspension and revocation of conformity assessment certificates