Letter from the TGA

Response from the TGA about “Raw Materials” Classification:

Dear Jon,

Thank you for your email and your patience awaiting a response while we experience a high volume of enquiries.

I have looked at the AuDental PDFs and products that you had sent through and note that they relate to products intended for use in the manufacturing of medical devices. There has been some ambiguity regarding the regulatory status of products such and whether they meet the definition of a medical device, or are a raw material.

The definition of a medical device in section 41BD of the Therapeutic Goods Act 1989 is as follows:

(1)  A medical device is:

(a)  any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

(i)  diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;

(ii)  diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;

(iii)  investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;

(iv)  control or support of conception;

(v)  in vitro examination of a specimen derived from the human body for a specific medical purpose;

and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means.

Please note that the introduction of the new regulatory framework for personalised medical devices has not changed the definition of a medical device. There is currently no definition of a raw material in TGA legislation.

The TGA has recently consulted on proposed refinements to the regulation of personalised medical devices which may result in some changes to the way such products are regulated. It is suggested you monitor the progress of the consultation on the TGA website.

I trust this information is helpful.

Kind regards,

Madeleine

Personalised Medical Devices Team
Devices Emerging Technology & Diagnostics Section
Medical Devices Surveillance Branch

Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606
www.tga.gov.au

For ongoing information and updates, please subscribe to the TGA’s Medical Devices Information and IVDs Information email subscription services.