Therapeutic Goods Administration (TGA) Australia has published a document regarding the refinements to the personalised medical device framework in August 2021.
After a public consultation regarding proposed refinements in July 2021, the refinements that have been included are “exclusion of specified products” and “declaration of some products to be medical devices”.
For the “exclusion of specified products”, the public consultation indicated the importance of the TGA’s role as the regulator of medical devices and that medical devices should not be excluded even where the risks associated with them are very low risk.
Products proposed for exclusion are:
- Products that are already excluded or that do not meet the definition of a medical device but where clarification of the product’s regulatory status would be beneficial.
- Accessories to medical devices for which regulation under the therapeutic goods regulatory framework is not commensurate with the risk that such products would pose to a user.
- Products that meet the definition of a medical device where the primary purpose is cosmetic.
- Anatomical models that are manufactured using a cast taken from a direct physical impression from a patient’s anatomy.
For the “declaration of some products to be medical devices”, the key points noted are:
- The manufacture of a medical device is a key component of clinical practice.
- The risks associated with devices manufactured by healthcare practitioners (HCPs), or technicians/laboratories are managed in a different way to mass-produced devices.
- Without the benefit of the custom-made medical device exemption and/or the inclusion of the materials/components used in these devices in the ARTG, it will be difficult if not impossible for some HCPs to continue supplying medical devices.
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