The Australian Therapeutic Goods Administration (TGA) has issued guidelines for the reclassification of Medical Devices and relative temporary arrangements.
The guidelines clarify the arrangements made by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019, which were scheduled to come into effect on 25 August 2020 but, due to the COVID-19 pandemic, have been postponed to 25 November 2021.
We should also keep in mind that the TGA is substantially changing the classification of Medical Devices and aims at making its standards more similar to those used in the European Union.
In view of the expiry date on 25 November 2021, date in which the classification rules should come into effect, it is advisable to plan now the actions needed to carry out a proper assessment and thus continue to market your Medical Devices in Australia.
Reclassification by category
The new classification rules apply to the following categories of Medical Devices:
- implantable spinal devices;
- active implantable devices;
- devices intended for the administration of medicinal products or biological products through inhalation;
- devices containing substances (or combinations of substances) to be directly input into the body;
- therapeutic active ingredients which include a diagnostic function;
- devices intended to be used in direct contact with the heart, the circulatory system or the nervous system.
For the time being, only the classification rules for the following three types of devices have been clarified:
- Active Medical Devices for Diagnostic Therapy: they must meet the regulatory requirements of Class III Medical Devices; prior to the effectiveness of the new regulation, these devices were classified as DM Class IIa/IIb.
- Medical Devices for the administration of medicinal products or biological products through inhalation: they must meet the regulatory requirements of Class IIa or IIb DMs.
- Active implantable Medical Devices (AIMD): these must be reclassified as Class III devices.
Deadlines and temporary arrangements for reclassified Medical Devices
For devices listed in the Australian Register of Therapeutic Goods (ARTG) before 25 November 2021, the Manufacturer or Sponsors must notify the TGA by 25 May 2022, in order to inform the Regulatory Authority that their product must be reclassified.
Following this, by 1 November 2024 the same organisations must submit the application to request the registration of their device in the ARTG register, according to the new classification rules.
In the event that the manufacturer does not submit the application by the second deadline (1 November 2024) the marketing of the device will be suspended.
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”Reclassification of active Medical Devices for therapy with a diagnostic function”, TGA, 12 may 2021
”Reclassification of Medical Devices that administer medicines or biologicals by inhalation”, TGA, 12 may 2021
”Reclassification of active implantable Medical Devices (AIMD)”, TGA, 12 may 2021
”Therapeutic Goods (Medical Devices – Application Form for Inclusion) Approval 2021”, TGA, 20 may 2021