Submissions received: Proposed changes to the medical device Essential Principles for safety and performance
The TGA thanks respondents who provided a submission in response to the public consultation paper: Proposed changes to the medical device Essential Principles for safety and performance.
This consultation was related to the implementation of the Australian Government Response to the Review of Medicines and Medical Devices Regulation (MMDR), in particular Recommendation 20 that prescribes that the regulation of medical devices in Australia, wherever possible, should be aligned with the European Union (EU) framework including in respect of the Essential Principles.
A total of twenty-one (21) submissions were received.
This consultation invited respondents to provide feedback on a proposal to revise Australia's Essential Principles for medical devices in line with international best practice - in particular the International Medical Device Regulators Forum (IMDRF) guidance and the EU Regulations for medical devices [including in vitro diagnostic medical devices (IVDs)].
The international requirements and guidance for principles regarding safety and performance of medical devices have changed, and Australia's existing Essential Principles no longer align with international best practice, particularly in areas where there have been changes and advancements in medical device technology.
The proposed changes outlined in the public consultation paper were based on international requirements and guidance, thereby promoting consistency between Australian and global requirements. This approach is intended to improve clarity and understanding to manufacturers and suppliers of medical devices when meeting Australian regulatory requirements. By removing barriers to regulatory compliance, these changes are expected to improve the safety and performance of medical devices.
The proposals in the consultation paper were to:
- amend the Essential Principles set out in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) to incorporate requirements specified in IMDRF guidance, and include additional details captured by the General Safety and Performance Requirements specified in the EU regulations;
- provide greater clarity for manufacturers for meeting existing expectations for compliance in areas of public health and safety, infection and contamination control, thereby ensuring adequate consideration of factors associated with components of medical device systems that are operated by a manufacturer including decommissioning and disposal, human and social factors, and ethics;
- restructure the current presentation of the Essential Principles to improve clarity and readability, including moving detailed requirements currently specified in Essential Principle 13 (labelling and instructions for use) into another area of the Regulations; and
- require software medical devices supplied without any physical packaging, to include the ARTG number on the electronic label.
Respondents were also asked to comment on the adequacy of proposed transition arrangements.
Summary of responses to proposals
While the majority of respondents agreed with the proposal to amend and restructure the Essential Principles, responses also showed:
- broad stakeholder support for the proposal to amend and restructure the Essential Principles to align with the requirements specified in the EU Regulations; and
- limited support for alignment with the IMDRF Essential Principles and Principles of Labelling.
The key objections to adoption of the IMDRF guidance were that they are not binding and have not been adopted by comparable overseas medical device regulators.
The majority of respondents:
- agreed with the proposals to incorporate new requirements and provide greater clarity (although some requested further consultation regarding the details of the proposed changes);
- prefer that changes not be excessively prescriptive;
- did not support the introduction of unique Australian requirements;
- disagreed with the proposed requirement for software medical devices to include the ARTG number on the electronic label as;
- this would be a unique Australian requirement and there would be potential difficulty with the practical implementation of this measure; and
- one ARTG number often covers multiple devices.
Stakeholders noted that the proposal to include the ARTG number with the device when supplied might be met with the introduction of the proposed Australian UDI. Few respondents commented on the specific proposal to move the labelling requirements to a separate section of the Regulations.
Overall, respondents did not anticipate that implementation of the proposed changes would represent a major financial burden providing they are limited to alignment with the EU Regulations. Should requirements unique to Australia be introduced, however, the financial impact would be greater.
Finally, while there was broad overall support for the four-year transition period for existing devices on the ARTG, several respondents did indicate that the period before commencement of requirements for new devices should be longer.
The TGA has considered the feedback received from the public consultation and will:
- incorporate the feedback, where appropriate, when drafting the proposed amendments to the Regulations; and
- undertake further stakeholder engagement to provide additional details of the proposed changes; and
- develop guidance material in support of the proposed changes to the Essential Principles.
The TGA acknowledges that in order to limit unnecessary regulatory burden of the proposed changes to regulations for stakeholders, the implementation date of the proposed changes should be after the implementation of the equivalent regulations in the EU. The implementation date and transition periods of the proposed regulatory changes will therefore take into account any changes to the implementation date of the EU regulations.
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- Consultation submission: Cochlear Limited (pdf,56kb)
- Consultation submission: Consumer Healthcare Products Australia (pdf,589kb)*
- Consultation submission: GE Healthcare (pdf,182kb)
- Consultation submission: Grant Woolcott, QARA Manager ANZ - name only
- Consultation submission: Mahesh Datar, Senior Regulatory Affairs Manager - name only
- Consultation submission: Medical Technology Association of Australia (pdf,1.48Mb)*
- Consultation submission: Medicines Australia (pdf,545kb)*
- Consultation submission: Minta Chen, Senior Manager Regulatory Affairs and Quality - name only
- Consultation submission: Mylan Health Pty Ltd (pdf,135kb)
- Consultation submission: ResMed Pty Ltd (pdf,688kb)*
- Consultation submission: Rhys David Thompson (pdf,805kb)*