With the current pandemic the TGA (Therapuetic Goods Administration) has made concessions on the supply of certain goods. Specifically, medical devices designed to be worn by people to prevent the transmission of organisms (Personal Protective Equipment – PPE) are exempt from compliance and registration requirements conditional on:
DTS can help you register these products on the Australian Register of Therapeutic Goods (ARTG).
Our consulting fees to help you include your products on the ARTG will be dependent on the class of device and the availability of the required evidence to support a medical device application.
Although the TGA are currently working to prioritise applications for devices that are required to manage the corona virus pandemic, they do not provide statutory time frames for processing applications. Additionally, there are other aspects of the process which we do not have control over and cannot predict how long they may take. This includes whether or not we first need to apply to have the manufacturer added to the TGA database if not already listed (this can take a up to a couple of days); if there are any deficiencies in the certifications/data; and whether there are any hold-ups in obtaining the manufacturer’s declaration of conformity from the manufacturer (this is a specific TGA template that will be provided to you once we commence work).
However, it is reasonable to plan for 2- 4 weeks in the current climate provided there are no major deficiencies and hold-ups.