Conformity assessment procedures
Australian medical devices guidelines
Guidance document number 3, Version 1.5
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.
This document outlines the obligations on manufacturers for the manufacture of medical devices for supply in Australia. These are known as the conformity assessment procedures.
Australian medical devices guidelines: 3. Conformity assessment procedures (pdf,83kb)
Contents
- Introduction
- What are the conformity assessment procedures?
- Part 1 - Full quality assurance procedure for Class AIMD, III, IIb or IIa medical devices
- Part 2 - Type examination for Class AIMD, III or IIb medical devices
- Part 3 - Verification Procedures for Class I, IIa, IIb, III or AIMD medical devices
- Part 4 - Production quality assurance for Class I (measuring or sterile), Class IIa, IIb, III and AIMD medical devices
- Part 5 - Product quality management system for Class I (measuring), IIa and IIb medical devices
- Part 6 - Declaration of conformity (not requiring assessment by Secretary) procedures for Class I, Class I (Measuring and Sterile) and IIa medical devices
- Part 7 - Conformity Assessment Procedures for devices used for a Special Purpose
- What are the common elements in all of the conformity assessment procedures?
- Post-market monitoring system
- Quality systems certification surveillance audits
- How do the TGA's conformity assessment procedures relate to those outlined in the European Medical Devices Directive (93/42/EEC)?
- Once a conformity assessment procedure has been followed, what are the next steps?
- How can EU conformity assessment certificates be used in lieu of TGA issued conformity assessment certificates?
- Which medical devices must have a TGA issued conformity assessment certificate before being accepted for inclusion in the ARTG?
- What are the special conformity assessment procedures?
- Attachments
- Attachment 1. Overview of conformity assessment procedures for medical devices of a particular classification
- Attachment 2. Choices of minimum conformity assessment procedures for medical devices of a particular classification
- Attachment 3. Kinds of medical devices which require a conformity assessment certificate from the TGA