New Classifications will Take Effect on November 25, 2021
Periodically, the TGA will adjust their regulations to better align their requirements with international standards. This process typically requires an announcement of proposed changes and time for industry feedback, followed by the official changes being stated in an announcement. This year, the TGA made significant changes concerning software, spinal implants, personalized devices, drug administering products, and companion diagnostics that affect many medical device manufacturers. Additionally, the Active Implantable Devices (AIMD) classification will be absorbed into Class III as of November 25, 2021.
Initially, many of the proposed changes were set to be implemented on August 25, 2020, but they were postponed to 2021 due to the COVID pandemic. However, even though the implementation was delayed, the transition period still ends on October 31, 2024, meaning there is now less time to transition to the new requirements for these devices.
The updated regulations apply to both software-based medical devices and programmable hardware, referred to as “programmed or programmable medical device, or software that is a medical device (SaMD).” The new changes align the Australia requirements with the EU’s MDR 2017 to help maintain easy access to CE Marked products in Australia.
As with non-software products, the new regulations will differentiate between products that are used by professionals or by lay people, allowing professional use to be classified lower. Devices that provide therapy based on information received will be classified as higher risk while devices that provide direct diagnosis or monitoring will remain the same. These classification changes do not apply to IVDs. The TGA has also updated their Essential Principles expected requirements to include information on cyber security, data management, and version controls while also allowing electronic IFUs or manuals for software only products.
These changes went into effect on February 25, 2021.
Classification Changes for Certain Products – Effective November 25, 2021
Spinal Implants – Class IIb to Class III
Motion preserving devices for the spine or that come in direct contact with the spinal column will be reclassified. For example, a spinal disc replacement will be a Class III while spinal fusion implantable devices such as rods, plates, screws, cages, or hooks will continue to be classified as Class IIb. All spinal implant applications will require an application audit.
Active medical devices for therapy with diagnostic function – Class IIa or IIb to Class III
Products that provide therapies through an internal diagnostic function which significantly determines patient management by the device (such as automated external defibrillators or closed loop systems) will now be a Class III. CPAPs and other positive airway devices will likely remain IIa.
Invasive Devices Used to Administer Medicines by Inhalation – Class I or IIa to Class IIa or IIb
Invasive medical devices intended to administer medicines or biologicals by inhalation will be classified as Class IIa, unless it could impact the efficacy of the medication or used to treat life-threatening conditions, where they will be Class IIb.
Direct CCS or CNS Contact – Class IIa to III
All surgically invasive devices used in direct contact with the heart, CCS, or the CNS regardless of the duration of use will now be classified as Class III.
Personalized Medical Devices
As the costs of custom-made medical devices continues to decline, the TGA has also updated their regulations to improve oversight over these types of products, which are also called “Personalized Medical Devices.” In addition to the following oversight requirements, the TGA will begin implementing the Medical Device Production System (MDPS) which will allow healthcare providers to produce personalized devices without the need for burdensome manufacturing certification.
Additional oversight steps include:
- Requiring sponsors to report custom-made devices supplied in the previous financial year;
- allowing the TGA to inspect production facilities;
- requiring documentation be retained for 5 years (non-implantables) or 15 years (implantables); and
- requiring manufacturers provide information about each custom-made medical device to the intended recipient
Classification in Australia
Medical devices are placed into one of five main classifications depending on the level of risk they pose. The classes are Class I, Class I Sterile/Measuring, Class IIa, Class IIb, Class III, and currently AIMD which will no longer be a category as of November 25 2021. The higher the classification level, the harder the requirements will be. Devices are classified by considering the manufacturers intended purpose, the degree of invasiveness, where in the body they are used, and the length of time it is used. The TGA has also created the following tool available to assist in determining the classification of medical devices.
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