Medical devices and therapeutic goods exempt from ARTG listing should still be flagged when supplied.
The Therapeutic Goods Administration should be notified when unapproved therapeutic goods or devices are supplied, even if they’re exempt from approval requirements, says the AMA.
In general, products that meet the legislative definition of a therapeutic good or medical device must be approved by the TGA and included on the Australian Register of Therapeutic Goods prior to import or supply.
But exemptions allow some products – such as homeopathic preparations and medicines that are extemporaneously compounded by practitioners – to circumvent these barriers.
In April, the TGA opened a consultation into proposed changes to the regulation of medical devices and therapeutic goods exempt from ARTG listing, after stakeholder feedback suggested that the current regulation was unfit for purpose.
In its submission to the consultation, the AMA supported three proposed changes to the regulation.
“We commend the initiative to re-examine current arrangements for exempt medical devices and other therapeutic goods in response to external stakeholder feedback and a noted increase in the use of exemptions,” it said.
“Consumer safety in the use of therapeutic goods must always be the key driver to implementing appropriate regulation that operates as intended.
“A robust regulatory framework should also preempt and mitigate against the risk of users misapplying or intentionally circumventing the system to remove barriers to manufacture and supply without adequate justification.”
The association noted the timeliness of the consultation, given the recent changes to the medical device regulatory framework.
The AMA “broadly agreed” that the TGA should be notified when exempt medications or devices were supplied.
“The use of a uniform platform as a means for collecting notification data from sponsors is an effective approach to more consistent, current data,” it said.
“The targeted information to be collected regarding notification of supply is also relevant and appropriate to the purpose of regulation.”
The AMA also agreed that the list of exempt goods should be made publicly available, and that for some exemptions, sponsors should be required to provide additional information upon demand.
“The AMA broadly agrees that sponsors of medical devices exempt under Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002 and all other therapeutic goods exempt under Schedule 5 or Schedule 5A of the Therapeutic Goods Regulations 1990 should be required to provide information about their product and/or a reasonable number of samples to the TGA upon request,” it said.
“The AMA considers extending the TGA’s authority to request further information and samples from sponsors registered under these arrangements to be proportional with the automatic conditions applicable to those items under the ARTG.
“It is also justified as an essential means of fulfilling the TGA’s obligation to conduct post market activities to assure safety, quality and performance standards for exempt medical devices.”
The AMA highlighted the following exemptions that it agreed should be excluded from the proposed changes to the notification and publication requirements:
- Special Access Scheme, supported by clinical justification through the medical practitioner or other health practitioner
- Devices/other therapeutic goods imported for the purpose of personal, singular or non-commercial use, such as the Personal importation scheme
- Samples of devices for particular uses like demonstration, audit, assessment already covered under TGA audit requirements
- Devices/ other therapeutic goods to which a Prescription Medicines Authorisation applies, such as vapes and associated products
- Those devices/ other therapeutic goods which are not made available to the public or to health providers, such as in-house IVD medical devices, and
- Those which feature as a limited exemption to address a time-sensitive supply issue or service persons visiting Australia for a limited time, such as a national or international sporting event.
“We also note these measures uphold protection of individuals’ private information and apply consistency between the requirements of publication only in cases where exempt goods warrant notification to the TGA,” it said.
