The present article describes in detail the aspects related to preliminary assessment Class III medical devices are subject to. In particular, it provides additional clarifications regarding the regulatory requirements should devices should comply with to be eligible for inclusion in the Australian Register of Therapeutic Goods (ARTG), the country’s register of regulated healthcare products.
According to the guidance, an application related to Class III medical device should meet the following requirements:
- It should be submitted in electronic format via the TGA Business Services (TBS) client’s portal.
- The form of the application should meet the requirements corresponding to its class.
- The appropriate application fee should be duly paid.
- The submission should contain all the information required, as well as the documents necessary for the conformity assessment. In particular, the documentation to be provided by the applicant should be sufficient to demonstrate that the device successfully passed the conformity assessment.
- Should the device require a TGA conformity assessment certificate, such a certificate should be duly provided.
- The applicant must certify the section 41FD matters.
Conformity Assessment Documents
First of all, the guidance outlines the scope of agencies entitled to issue documents that would be admissible in terms of applying for inclusion in the ARTG. According to the document, the document could be issued by:
- Notified Bodies designated under European Union medical device regulatory frameworks;
- United States Food and Drug Administration (FDA);
- Health Canada;
- Relevant Japanese authorities;
- Medical Device Single Audit Program (MDSAP) Auditing Organisations (AO).
The TGA additionally emphasizes that for the documentation to be admissible, it should be issued for the same medical device having the same design and intended purpose, and intended for the same clinical indications.
The authority also mentions that the device should meet any requirements, including the ones related to the design of a medical device and manufacturing process, which are imposed due to conformity assessment procedures.
According to the guidance, the conformity assessment procedures to be applied about Class III devices are either:
- The full quality assurance procedures (including design-examination); or
- The type examination procedures and the production quality assurance procedures (as per Regulation 3.6(2) of the Therapeutic Goods (Medical Devices) Regulations 2002).
The admissible documents related to conformity assessment procedures include, inter alia, TGA conformity assessment certificates, EC certificates issued by a notified body, EU quality management system certificates, or MDSAP certificates.
It is also stated that in case the medical device manufacturer has any doubts regarding the regulatory status of its product and the respective conformity assessment procedures it should be subject to, the manufacturer shall contact the regulating authority and ask for additional advice. The same approach could be applied in case of any questions regarding the conformity assessment documents the manufacturer has. The TGA additionally emphasizes the importance of providing correct documents to avoid refusal.
Audit Assessment of Class III Applications
Under the general rule, applications related to Class III medical devices should be subject to an audit. As it is further explained by the TGA, the level of audit (Level 1 or Level 2) may depend on the category of a medical device and the overseas regulatory conformity assessment document(s) provided with the application. It is important to mention that the appropriate audit assessment fee should be paid by the applicant.
Should the application submitted by the manufacturer be selected for such an audit, the manufacturer will have to provide the information and documentation sufficient to demonstrate that the device in question complies with the applicable essential principles. According to the guidance, the scope of documentation the applicant will have to provide includes:
- Instructions for use,
- Manual and product brochure, and
- Clinical evidence for the device.
The document also describes the approach to be applied when determining the level of audit and also provides examples of decisions that could be taken in this regard.
For instance, according to the example provided by the TGA, in case of an application for inclusion in the ARTG submitted about Class III medical device, which has been already approved for marketing and use by the US Food and Drugs Administration (FDA), the US regulating authority in the sphere of healthcare products, will still be subject to preliminary assessment and audit as described herein.
The level of application audit should be determined depending on the information regarding the device available for TGA. In particular, according to the guidance, Level 2 should be applied in case:
- The device does not appear to be the same as the device specified in the PMA (including differences in the UPI, design, intended purpose, or clinical indications); or
- Other signals raise safety or performance concerns.
The TGA explicitly states that when using documentation issued by a foreign agency to demonstrate conformity, the applicant shall be able to demonstrate that the appropriate documentation has been issued for the same product.
Should none of the criteria outlined hereinabove be applicable, a Level 1 audit should take place.
The regulating authority additionally emphasizes ensuring compliance with the applicable essential principles in terms of safety and effectiveness. In particular, it is the sole responsibility of a medical device manufacturer applying for inclusion in the ARTG to provide information and documentation demonstrating such compliance.
Apart from the ones described here above, the present TGA guidance highlights other important aspects associated with a reclassification of surgical mesh medical devices. For instance, it is stated that in case the device in question is subject to reclassification, it should be described in a separate ARTG entry. Hence, should the application for inclusion in the register be accepted and approved, an entirely new entry will be created. Once completed, the manufacturer responsible for a medical device will be allowed to apply for updating the listing of the device in the Prostheses List, if applicable. It is stated that the correctness of entries associated with the device is vitally important to ensure consistency in records that later will be used in the context of health insurance and reimbursement. To update the appropriate entry in the Prostheses List, the manufacturer shall submit an application accompanied by the new ARTG certificate and catalogs.
In summary, the present TGA guidance addresses the most important aspects associated with the reclassification of surgical mesh devices. The document highlights the matters to be considered by medical device manufacturers intended to apply for inclusion of their products in the Australian Register of Therapeutic Goods under the new classification rules for surgical mesh medical devices.
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