The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable overseas regulators/assessment bodies for both general and in vitro diagnostic medical devices.
The document covers cases when such evidence is being used to supplement applications for inclusion of medical devices in the Australian Register of Therapeutic Goods and conformity assessment. It is intended to provide medical device manufacturers and other parties involved with additional clarification and recommendations.
Please note that the provisions of the guidance are non-binding due to the status of the document. Consequently, in case of any discrepancies with provisions of the applicable Australian legislation on medical devices, the latter shall prevail. Moreover, the TGA reserves the right to modify the present guidance and make changes to the recommendations contained therein if it is deemed reasonably necessary to reflect the changes to the respective regulatory requirements. The recommendations provided in the guidance can be used by the medical device manufacturers when determining the actions to be taken in order to achieve and sustain compliance with the applicable regulatory requirements.
Regulatory Background
The TGA continues implementation of the consequent steps necessary to improve the country’s regulatory framework for medical devices and align it with the best practices adopted in other countries, especially in so-called trusted jurisdictions – the countries with the most advanced regulations in the sphere of medical devices, such as the EU member states, the US, the UK, Canada, and Japan. Further harmonization of regulatory requirements would also simplify the regulatory procedures to be performed when placing a new medical device on the Australian market and facilitate the conformity assessment to be performed in this regard.
In particular, the TGA intends to introduce special simplified procedures to be applied if the medical device in question has already passed a conformity assessment conducted by the respective regulating authority of a foreign jurisdiction, or has already been approved by such authority for marketing and use. The suggested approach is intended to reduce the regulatory burden for the foreign medical device manufacturers and also ensure and expand the availability of novel medical devices on the Australian market. However, the TGA additionally emphasizes that the approach described in the guidance does not limit in any way the powers and responsibilities of the TGA as an Australian regulating authority in the sphere of medical devices.
The present TGA guidance describes the particular way the interested parties may refer to the foreign assessment evidence or approvals when applying for marketing authorization in Australia. The document is based on the following regulations:
– Therapeutic Goods (Overseas Regulators) Determination 2018, and
– Therapeutic Goods (Medical Devices – Information that Must Accompany Application for Inclusion) Determination 2018.
As mentioned, in case of any discrepancies, the interested party shall rely on the provisions of the aforementioned regulations.
Rules on Overseas Evidence
First, the present TGA guidance describes the overseas evidence admissible in the context of premarket review and assessment. According to the document, in certain cases, the evidence provided by foreign regulating authorities would be accepted by the TGA. The list of the acceptable documents includes:
– Certificates issued by Notified Bodies designated by the medical device regulators of European member states, under the medical device regulatory frameworks of the European Union (Medical devices directives, Medical Device Regulation, or IVD Regulation),
– Decisions of the United States Food and Drug Administration (FDA),
– Approvals and licenses issued by Health Canada,
– Pre-market approvals from Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body (RCB), whatever is applicable,
– Certificates and reports issued under the Medical Device Single Audit Program (MDSAP),
– ISO 13485:2016 certificates issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC (for IVD inclusion applications only until 26 May 2022),
– ISO 13485:2016 certificates issued by a body that is an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (for IVD inclusion applications only until 26 May 2022).
Additionally, the documentation from the list above should be related to a medical device which has exactly the same design, intended purpose, and indications for use.
Additional Regulatory Requirements
The document also describes additional regulatory requirements to be applied in the context of the use of market authorization evidence and approvals issued by the foreign regulating authorities for supplementing the applications for inclusion in the ARTG.
The TGA also mentions that in the cases described herein, the assessment fee charged by the authority could be subject to reduction due to the actual reduction of the scope of work to be performed by the authority due to the use of existing evidence and documents.
1. Abridgment of the conformity assessment to be performed by the regulating authority. The documents issued by the foreign regulating authority should clearly demonstrate that the medical device in question meets any and all applicable requirements and also complies with the essential principles in terms of safety and effectiveness. Should such documents be provided by the interested party, the TGA would be able to reduce the scope of assessment to be performed, which will facilitate the regulatory procedures to be carried out before placing a medical device on the market. The present TGA guidance further describes the requirements the documents issued by foreign regulating authorities should meet in order to be admissible.
2. Application for inclusion in the Australian Register of Therapeutic Goods. The documentation submitted by the interested party should cover the whole scope of information required for the inclusion of a medical device subject to review in the ARTG, otherwise, the TGA would be entitled to deny the request. Such documentation could include the manufacturer evidence, and the evidence of product assessment.
The authority also mentions that it reserves the right to conduct an additional audit of the documentation submitted by the interested party. Such a decision could be taken if TGA has reasonable concerns with regard to the medical device itself or the documentation submitted. The actual scope of such an audit would depend on the class of a medical device in question under the risk-based classification and the documents provided. It is also stated that in the case of applications related to in vitro diagnostic medical devices, it would be sufficient to provide the evidence of product assessment from a comparable overseas regulating authority in order for the requirement on a mandatory assessment to be waived.
In summary, the present TGA guidance describes the approach to be applied with regard to the evidence and approvals issued by the foreign regulating authority. In particular, the document highlights the most important aspects related to the use of foreign documentation for the purpose of facilitating the regulatory procedures related to inclusion in the ARTG.
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