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.
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:
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.
The impact of the COVID-19 pandemic can be seen in the postponement of the new amendments, as well as in a special discount included in this fiscal year’s fee schedule.
Other countries that plan to adopt the legislation or align elements of their own regulatory systems with it must now decide how to proceed.
In addition to issuing emergency measures addressing COVID-19, the regulatory body proceeds with business as usual.
The regulatory body has established exemptions and expedited pathways to ensure ready supply of devices needed to counter the spread of the disease.