Based on feedback supplied by the AHTA TGA Steering Group and others, significant amendments have been made to the personalised medical devices framework.
Details can be found in the attached email, which includes links to regulatory amendments and to a discussion paper – further amendments are anticipated.
By way of summary, from the TGA:
The Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Personalised Medical Devices) Instrument 2021 declares certain products, including materials and components used in the manufacture of some medical devices (predominantly in the dental sector) to be a medical device. There are two main groups of products/devices that have been included in this instrument:
- materials and other articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner in the manufacture of externally-applied orthopaedic devices, including but not limited to: (a) fibreglass bandages used in the manufacture of splints or orthoses; (b) software; (c) thermoplastic sheeting used in the manufacture of splints or orthoses
Note If you are a: healthcare practitioner who manufactures a specific device as a component of your clinical practice; or an entity who manufactures specific devices for a healthcare practitioner as a component of their clinical practice, you will not be required to register your devices for transition or include them in the ARTG if you are making them from an ARTG-included material or component (s).
If you have already registered your devices for transition you are not required to take any further action. If you are directly importing a material, component(s) or finished medical devices for use in your practice, you will need to include these products in the ARTG.
After an initial review, it seems some questions remain including devices manufactured using a combination of declared products (eg. fibreglass bandages) and non-declared products (eg. wire).
Any remaining issues such as these would seem likely to be able to be rectified as part of further flagged consultation and amendments. By way of example, declared products in relation to dental devices include the following.
- orthodontic components (such as bands, brackets, chains, elastics, ligature ties, separators and wire)
- wrought wire used in the manufacture of clasps or retainers
All going well, we anticipate that in due course confirmation will be provided that members will not need to register any devices with the TGA ongoing.
In the meantime, if your business ‘manufactures’ or intends to manufacture devices including component products which have not been declared, and you have not registered a TNF, you need to do so by COB today.
As noted in the TGA advice above, if you have already registered, then no further action is required by the most recent regulatory amendments.