TGA on Changes to Implementation Delay

Medical Device Regulatory Changes

The TGA acknowledges difficulties faced by medical device manufacturers and other industry representatives due to the impact of factors associated with the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus.” These difficulties are related to the significant increase in demand for certain types of medical devices that are vitally important during the pandemic. This also applies to the restrictive quarantine measures implemented by countries in order to prevent further spreading of the infection by reducing the number of face-to-face contacts to the lowest extent possible. In order to assist medical device manufacturers in dealing with the aforementioned issues while maintaining compliance with the applicable requirements, the TGA suggested postponing the actual implementation of planned changes to the medical device regulatory framework. This additional time is also necessary for the authority to be able to perform additional consultations with industry representatives regarding such changes. 

The initial implementation date should have been August 25th, 2020. However, in accordance with the proposal submitted by the TGA, the actual implementation will be postponed in the following way:

1. From November 25, 2021, reclassification rules should be applied for active and spinal implantable medical devices, medical devices used to administer medicines, active medical devices for therapy, and also medical devices designed to be used in direct contact with the heart, the CCS or CNS. 
2. From February 25, 2021, new requirements for medical software and personalized medical devices should be applied. 
3. From November 25, 2021, new requirements for systems should be applied. 

The TGA also stated that additional information regarding the implementation of the new medical device regulations would be available later. Due to potential changes and the impact of COVID-related factors, the whole implementation process could be subject to this. 

The proposed delay would also cover amendments to Essential Principles in the Australian Medical Device Regulations. According to the present TGA notice, the aforementioned delay would provide medical device manufacturers and other parties involved in operations with medical devices with additional time to take all necessary measures to maintain compliance with applicable regulations and upcoming changes to the regulatory framework. 

Australian Medical Device Classification Rules 

In order to assist medical device manufacturers and other parties placing medical devices on the Australian market (such as importers or suppliers, together “sponsors”) with the correct determination of a class of the medical device, the TGA provides a special classification tool that is available online via the official TGA website. This tool allows manufacturers to determine the class in accordance with the risk-based classification that the device in question should be assigned to. 

According to information published by the authority, medical devices should be classified depending on the potential harm that could be caused to a patient’s health when using the device for its intended purpose. It is also important to mention that the general classification rules do not cover in vitro diagnostic medical devices which due to their specific natures, should be subject to special regulation and classification. 

Australian medical device classification system provides the following classes of medical devices:

• Class I – medical devices with the lowest risk,
• Classes Is, Im – low risk,
• Class IIa – low to moderate risk,
• Class IIb – moderate to high risk,
• Class III and Active Implantable Medical Devices – high risk. 

As it was mentioned before, the class of medical device in question should be determined in accordance with the intended purpose as indicated by the medical device manufacturer. If the device is intended for several purposes, the one subject to the highest classification should be used. At the same time, if under the general rule, the medical device falls within the scope of several classes, the highest one should be applied. If the device is intended to be used in a combination with another medical device, each of the devices should be evaluated separately. The software the device contains should be assigned to the same class as the device itself. 

Pre-determined Medical Device Classification Groups

In order to simplify regulatory procedures associated with the classification of medical devices, the TGA has implemented a set of pre-determined groups to be applied depending on the specific features of the medical device in question. 

In particular, the TGA provides the following Groups:

• Group A, which covers medical devices containing a medicine, or materials of animal origin, or any materials of microbial or recombinant origin.
• Group B, which includes implants and active implantable medical devices, with the accessories thereto, and the devices intended to control or monitor active implantable medical devices.
• Group C, which includes medical devices intended for disinfecting purposes, and also ancillary medical devices. 
• Group D, which includes non-active medical devices intended to record X-ray diagnostic images. 
• Group E, which includes medical devices indeed to be exported or to clean other medical devices.

The further steps to be performed in the course of the classification process would depend on the Group chosen by the applicant (medical device manufacturer, importer, or supplier).

Key Definitions For Medical Devices

The TGA also provides definitions of the most important terms related to medical devices and their classification. The list of definitions includes, inter alia, the following ones:

• Accessory – an element intended by the manufacturer to be used together with the medical device. 
• Joint replacement medical device – an implantable device intended by the manufacturer to operate as a replacement, that provides replacement, fixation, and connection, providing that it is not an ancillary medical device.
• Ancillary medical device – an implantable medical device consisting of screws or wedges and intended to provide stability, bone substitution, or otherwise assist any such device if it’s reasonably necessary due to the individual requirements of the particular patient. 

One of the most important concepts related to medical devices is its intended purpose, defined as a particular purpose indicated by the medical device manufacturer as one the device should be used for. Such indication should be included in:

• the instructions for use (IFU),
• technical documentation provided by the manufacturer,
• marketing and advertising materials,
• any other information supplied with the device. 

Summarising the information provided hereabove, the TGA intends to postpone the actual implementation of planned changes to Australian regulations on medical devices in order to provide medical device manufacturers with the additional time necessary to become compliant with the new requirements. This delay is mostly caused by the impact of COVID-related factors, including restrictive quarantine, and other temporary extraordinary measures introduced in Australia and other countries.

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Sources:
https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd
https://www.tga.gov.au/sme-assist/what-classification-my-medical-device