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  • Writer's pictureStuart Anderton

Certificate of regulatory rationale

This document serves to clarify the regulatory rationale adopted by Osseo Group Pty Ltd concerning the non-registration of raw materials used in the production of medical devices, in accordance with the Therapeutic Goods Act 1989.


Focus on Final Medical Products

In compliance with the Therapeutic Goods Act 1989, our regulatory focus is directed towards ensuring that final medical devices meet rigorous safety and efficacy standards before their registration on the Australian Register of Therapeutic Goods (ARTG). The Act emphasises that the registration and listing processes are intended for finished medical products, as outlined in Division 2, Part 3-2 of the Act. This ensures that the integrated components meet these standards indirectly through the final product, which encompasses the Essential Safety and Performance Requirements.


Examples Illustrating Regulatory Focus


Example 1: Implantable Titanium Implant - Class 2b device


This example demonstrates how regulatory oversight is applied to the device as a whole rather than its raw materials. The titanium used in a Class 2b implantable device is essential for its function but is not itself subject to separate registration. This underscores the regulatory principle that the safety and effectiveness of the final product, as tested and evaluated in its complete form, are the primary concerns. The focus on the final product ensures that all components, including the titanium, meet necessary standards when integrated into the final implant, rather than requiring separate regulatory scrutiny for the raw titanium itself.


Example 2: Intraoral Scanner - Class 2a Device


This example highlights how complex devices, composed of various technical components, are regulated based on the complete device's compliance with regulatory standards. Components like cameras and plastics within the scanner are critical to its function but do not individually require listing on the ARTG. The regulatory assessment is focused on how these components work together within the final product to meet predefined safety and efficacy standards.


Application to Dental Crowns

The rationale behind this regulatory approach can be directly applied to the use of zirconia and porcelain in the production of dental crowns.

  • Zirconia - Used as the core material for the framework of the dental crown due to its excellent durability and aesthetic qualities.

  •  Porcelain - Applied as a veneer over the zirconia framework to enhance the appearance and ensure the crown mimics the natural look of teeth.


Assessment of the Final Product

The regulatory assessment under the Therapeutic Goods Act focuses on the dental crown as a complete product once it is finished. The evaluation determines whether the crown, as a whole, meets the required standards of safety and efficacy.


Non-requirement for Individual Component Listing

Materials like zirconia and porcelain, used in the fabrication of dental crowns, do not need to be individually listed on the ARTG. The Act prioritises the registration of the complete device (the dental crown in this instance), rather than the raw materials or components used in its construction.


Ensuring Compliance through Finished Product

The focus remains on ensuring that the complete dental crown complies with the necessary regulatory standards, rather than focusing on the separate components. This method simplifies the regulatory process, ensuring resources are efficiently utilised to assess the safety and effectiveness of finished medical devices.


It is important to note that currently, this medical device (dental crown) is exempt from being listed on the Australian Register of Therapeutic Goods (ARTG) until mid-2029 when the patient-matched device scheme comes into effect. At that time, the dental crown will be classified as a Class 2a patient-matched device, reflecting its tailored design for individual patient use. This forthcoming classification change underlines our ongoing commitment to comply with evolving regulatory requirements and ensures our readiness to adapt to new regulatory environments to maintain the highest standards of safety and effectiveness.


Regulatory Oversight and Compliance

Osseo Group acknowledges that while some manufacturers may register raw materials on the ARTG, either by misinterpretation or as a compliance-based marketing strategy, such registrations do not align with the legislative intent. Our regulatory framework includes robust mechanisms for audits and compliance reviews (Division 2A, Part 3-2), ensuring any deviations are identified and corrected.


Authority for Cancellation of Incorrect Registrations

Under Section 30 of the Act, the Secretary holds the authority to cancel any registrations or listings that are found to contravene the regulatory standards. This provision safeguards the integrity of the ARTG and ensures compliance with the legislative framework.


Preparedness for Future Regulations

We remain vigilant and prepared to integrate and comply with any forthcoming regulatory changes, including those potentially introduced by Medical Device Production Systems. Such changes would be adopted following comprehensive industry consultations and a phased implementation approach.


Commitment to Compliance

Osseo Group Pty Ltd is committed to upholding the highest standards of compliance and regulatory adherence, ensuring that all our medical devices delivered to the market are safe, effective, and of the highest quality.


This certificate is provided for general information purposes and to affirm our commitment to regulatory compliance and excellence in medical device sales and service.



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