In a bid to harmonize regulatory practices and streamline the approval process for medical technologies, the Therapeutic Goods Administration (TGA) has initiated a consultation to align Australian Essential Principles with European Union (EU) Regulations’ General Safety and Performance Requirements (GSPR). This move marks a significant step toward improving market access, ensuring safety, and fostering innovation in the medtech sector. The goal is to explore how Australian regulatory principles can be aligned with the EU’s robust framework, enhancing consistency and reducing duplication in regulatory processes.
The medtech industry plays a crucial role in enhancing healthcare outcomes through innovative devices, diagnostic tools, and therapeutic technologies. However, regulatory frameworks governing these technologies can vary significantly between regions, leading to challenges for manufacturers and impacting the speed at which new technologies reach the market.
In Australia, the TGA is responsible for regulating medical devices and ensuring they meet safety, quality, and performance standards. The European Union, with its well-established Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR), provides a comprehensive regulatory framework that many consider a benchmark for global standards. In a comparison study, the TGA was able to identify aspects of the EU regulations that are additive to the Essential Principles with regard to safety and performance and where improvements on the intent of compliance expectations by medical device manufacturers can be improved.
The TGA’s consultation seeks to gather feedback from stakeholders, including industry professionals, medical technology companies, healthcare practitioners, and consumer groups in sixteen (16) proposals it has put forth. Included in those is the proposal for new principles that align with three EU requirements that are focused on the maximum reduction of risk that can be achieved without a negative impact on the overall benefit-risk ratio (commonly referred to as reducing risk “as far as reasonably practical” or AFARP), adding risk-management systems and efforts to reduce or remove user errors.
Conversely, there are some areas within the EU regulations that the TGA will not be adopting, including
phthalate guidelines, risks of substances released from devices and the presence of endocrine disruptors.
The TGA is keen to hear from all relevant stakeholders to ensure that the alignment process considers diverse perspectives and practical implications, including their proposed transition periods as follows
- Four years for any new or existing or new device applications
- Six years for devices that are already included in the Australian Register of Therapeutic Goods
The feedback will play a crucial role in shaping the final approach to regulatory alignment, ensuring that it meets the needs of both the industry and the public. Stakeholders are encouraged to provide their insights on various aspects of the proposed alignment, including potential challenges, benefits, and any areas where further clarification may be needed. The consultation process is designed to be inclusive, with opportunities for written submissions and stakeholder meetings.
Feedback is welcomed until October 16, 2024. For more information on how to participate in the consultation, interested parties can visit the TGA’s official website or contact the TGA directly.
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