Dec 15, 2020
Australia’s Therapeutics Goods Administration (TGA) published a noteworthy regulatory update, Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment (COVID-19 Measures—Class 1 IVD Medical Devices) Determination 2020. New in this amendment, effective as of December 4, is the requirement to include the manufacturer's Declaration of Conformity (DoC) in the Australian Register of Therapeutic Goods (ARTG) application for all Class 1 IVDs.
Guidance clarifies Declaration of Conformity procedures for low-risk medical devices, IVDs, and SOPPs
Accompanying the update was the publication of a new guidance document to assist manufacturers in completing the required DoC. Guidance for Declaration of Conformity for Class I non-Sterile non-Measuring and Class 1 in vitro diagnostic (IVD) medical devices is also intended to help sponsors confirm that documentation has been prepared correctly by manufacturers. In addition to Class I (non-sterile, non-measuring) medical devices and Class 1 IVDs, the guidance covers Class 1 Systems and Procedure Packs (SOPPs).
The guidance provides clarity on what information to enter in the various fields of the DoC, consisting of the following:
- Manufacturer’s name
- Business address
- Classification
- GMDN code and term
- Standards applied to the device(s)
- Name of the medical device(s) / IVD(s)
- Declaration
- Signature
Also provided in the guidance are notes on what is required of the manufacturer relating to the Essential Principles, technical documentation, and post-market surveillance.
Templates for the manufacturer’s Declaration of Conformity for IVDs and SOPPs can be found on the TGA website here. Corresponding templates for medical devices are available here.
Related resources on Australian medical device regulation:
- Australia emergency use pathways for medical devices
- Australian TGA medical device registration consulting
- Australian TGA Sponsor in-country representation
- Whitepaper: Medical device registration in Australia and New Zealand
Author
- Timothy Herr