Australia’s Therapeutic Goods Administration (TGA) published a consultation paper on 11th February 2019 to receive effective feedback from the industry regarding the proposal of reclassifying spinal implantable medical devices to a higher level of classification. The proposal is an effort by the TGA to align its Regulatory requirements with that of the European Union’s Medical Device Regulations (EU MDR). The decision was taken after a report was received from the Australian government consisting 58 recommendations from a 2015 Expert Panel Review of Medicines and Medical Device Regulations to reform the Regulatory framework of the TGA with respect to medicines and medical devices.
Several amendments were made to the EU regulations for medical devices (2017/745) which reclassified some of the medical devices to higher risk categories. Likewise, the TGA is aiming at introducing a new classification rule for the regulations of spinal implantable medical devices. According to the agency, the new classification rule will be included in the Therapeutic Goods (Medical Devices) Regulations 2002 in-line with the last paragraph of Rule 8 (Annex VIII, Chapter III) of the EU MDR (namely Regulation (EU) 2017/745). This would result in the reclassification of all the spinal implantable medical devices from Class IIb (medium-high risk) to Class III (high risk).
As of now, existing Australian MDR does not have any specific classification rule or guideline for spinal implantable medical devices. But it has been observed that Rule 3.4 of the Australian MDR nearly applies to them.
To align with the EU MDR’s Rule 8, a new classification should be included in Part 3 (for invasive medical devices and implantable medical devices), Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002. According to this new classification, a device will be classified as Class III, if it is an implantable medical device intended to be used as a replacement for spinal disc or it comes into contact with the spinal column by its manufacturer.
How are the manufacturers affected?
If the Regulatory changes come into effect, sponsors entering the Australian market will be required to submit the conformity assessment documents of the manufacturers. The sponsors of spinal implantable medical device will also be required to apply for inclusion of their devices as Class III in the Australian Register of Therapeutic Goods (ARTG). If the inclusion is successful for devices falling under the Prostheses list, a new ARTG entry for the device will be issued by the agency.
Terms of Transition
The TGA has proposed to bring the new classification for spinal implantable medical devices in Australia from August 2020. If an application is submitted to the agency before the implementation of the rule, the sponsor will have to make the necessary transition arrangements within the transition period. Once the proposal takes effect, the following actions might be required:
- Applications submitted to the TGA on or after the date of the amendment should classify under Class III medical device, for the marketing approval of spinal implantable medical devices.
- ARTG approved sponsors of spinal implantable medical devices must apply for their devices to re-enter as a Class III medical device. These applications are required to be submitted to the TGA by 2020. In case, an application for reclassification or a new application is submitted to the TGA and is not cleared by the end of the transition period, the device can continue to be distributed as Class IIb ARTG entry until classified as Class III.
- Sponsors must notify the agency regarding all the devices currently supplied under Class IIb classification and require transition provisions. The notification must be sent within 6 months of the implementation of the regulation. The sponsors can continue to distribute these devices till the end of the transition period. If the sponsor fails to notify the TGA within the specified period, the devices will not be eligible for the transition provisions.
- If an application is under process when the new rule comes into effect, the application will continue as per the earlier regulations and will be classified as Class IIb (if approved). After the approval, the sponsor will be required to re-apply for the reclassification of the device for inclusion in ARTG as Class III.
Even though the new regulations are adopted from the EU MDR, they have been altered to align with the legislation of Australia. The industry experts are requested to consider all the aspects of the new and the old classification before submitting the consultation paper and feedback. The TGA will accept the feedback on this matter till 25 March 2019.
Whether the proposal is in the favor of the TGA or not, it can only be decided once the feedback is received from the industry. Till then, enter the Australian medical device market compliantly. Stay informed. Stay compliant.