Variants for Class III and AIMD medical devices
Australian medical devices guidelines
Guidance document number 13
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.
The regulatory framework for medical devices incorporates the concept of "kinds of medical devices", and an inclusion on the Australian Register of Therapeutic Goods (ARTG) is for a "kind of medical device". [Refer Section 41BE of the Therapeutic Goods Act 1989 and Regulation 1.6 of the Therapeutic Goods (medical devices) Regulations 2002.]
Contents
- Introduction
- Same "kinds of medical devices"
- Unique Product Identifier (UPI)
- Definition of a variant
- What is, and what is not, considered a variant
- Entering variant details in a DEAL application
- Changing variant details of an existing ARTG entry
- Requesting the addition of a new allowable variant
- Attachment 1 - Table of allowable variants