The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidelines describing the process of inclusion of medical devices in the national register.
The present guidelines describe:
- The process an interested party shall follow to include its product in the appropriate national register,
- Each particular step of the aforementioned process,
- Connections with other relevant regulations,
- Completion of the medical device inclusion process.
According to the current legislation, to be approved for marketing and use in Australia, all medical devices should be included in the Australian Register of Therapeutic Goods (ARTG), the country’s database containing information about all healthcare products. This requirement applies to all medical devices except those falling within the scope of a specific exclusion or exemption.
In particular, the requirement for inclusion of a medical device in the ARTG could be waived if the device is supplied to Australia under one of the frameworks listed below:
- Clinical Trials in Australia,
- Authorized Prescribers,
- Special Access Scheme,
- Personal Importation,
- Exemptions in the national interest to deal with emergencies.
The new guidelines published by the TGA are intended to provide medical device manufacturers and other parties involved with additional clarifications and recommendations regarding how information about a medical device should be included in the ARTG before the device is placed on the market. The regulatory matters related to general and in vitro diagnostic (IVD) medical devices are addressed in separate documents. It is also important to mention that the present guidelines do not cover the aspects related to exporting medical devices from Australia. However, in order to be eligible for issuing a Certificate of Free Sale, which is required for marketing in other countries, the medical device in question should be included in the Australian register.
The existing regulatory framework for medical devices is based on:
- The Therapeutic Goods Act 1989,
- The Therapeutic Goods (Medical Devices) Regulations 2002, and
- The Therapeutic Goods Regulation 1990.
Irrespectively of the type of medical device subject to review, the inclusion process consists of the following steps:
1. Determining whether the product in question meets the definition of a medical device and thus is subject to inclusion in the ARTG.
2. Considering the most important aspects related to the medical device, such as its type, class under the Australian risk-based classification, the evidence available, eligibility for a priority review, additional documentation.
3. Getting access to the special online portal used for e-fillings – TGA Business Services system (TBS).
4. Submitting an application in accordance with the regulatory requirements based on the class of a medical device.
5. Application review and processing by the TGA.
6. Issuing the certificate of inclusion.
The authority also mentions that there are additional obligations related to post-market monitoring the party responsible for a medical device shall follow.
Special Rules for IVD Medical Devices
Apart from the general rules that apply to medical devices of all types, the TGA also describes specific requirements to be applied in the case of in vitro diagnostic medical devices. For instance, in accordance with such special rules, Class 1-3 in-house IVD medical devices are required to be entered on an in-house IVD database that is separate from the ARTG.
The authority additionally emphasizes that only an entity based in Australia is allowed to act as a sponsor and apply for the inclusion of a medical device in the ARTG. The IVD medical device is eligible for inclusion in the register if:
- It complies with the applicable Essential Principles, and
- All necessary conformity assessment procedures took place.
The TGA reserves the right to introduce additional requirements reasonably necessary to ensure the safety and effectiveness of medical devices intended to be marketed and used in Australia.
The particular procedure a sponsor shall follow in order to apply for the inclusion of an IVD medical device in the ARTG will depend on the type of medical device in question. According to the document, different procedures should be applied for:
- IVDs intended for export only,
- Class 1 IVDs,
- IVDs other than Class 1.
The document describes in detail the procedures to be applied in each of the aforementioned cases.
1. In vitro diagnostic medical devices intended to be exported are subject to inclusion in the register as Class 1 IVDs. Moreover, such devices are not allowed to be marketed and used in Australia. The devices imported for future exporting are exempted from mandatory inclusion in the register, provided they will not be made available in the country. Such medical devices should be treated as goods and not as medical devices.
2. In the case of IVDs intended for use in Australia, the procedure should be different. Upon submission of the application, the authority will select some of them for a Technical File Review. In such a case, the TGA will conduct an additional review of the information contained in the application before granting approval. The medical devices for which the applications were not chosen by the authority for a Technical File Review will be subject to automatic inclusion in the ARTG.
3. The regulatory requirements for in vitro diagnostic medical devices other than Class 1 are more detailed due to the higher risks associated with such devices. Thus, the manufacturer shall submit additional evidence (the Manufacturer`s Evidence) demonstrating that the medical device in question meets any and all applicable requirements in terms of safety and performance. As in the case of Class 1 IVDs, the TGA will choose some of the applications for a Technical File Review.
The Manufacturer`s Evidence mentioned above refers to the quality management system (QMS) certificate or conformity assessment certificate. This requirement applies to in vitro diagnostic medical devices other than Class 1. Nevertheless, the manufacturers of the latter are also obliged to employ necessary conformity assessment procedures. They must prepare a Declaration of Conformity, which should be provided to the authority together with the initial application. Moreover, the authority reserves the right to request the medical device manufacturer or other entity applying for inclusion to provide evidence of conformity. In the case of Class 2, 3, and 4 IVDs, the submission of the Manufacturer`s Evidence is mandatory. Thus, if a sponsor and medical device manufacturer are different entities, a sponsor shall request and obtain the appropriate QMS certificate or conformity assessment certificate from the manufacturer.
In order to apply for inclusion of a higher-risk medical device in the ARTG, a sponsor shall:
- Obtain a conformity assessment certificate from the manufacturer (if required).
- File a completed application form together with all the documentation required (e.g., a Declaration of Conformity for Class 1-3 IVDs or a Design Examination / Type Examination certificate issued by the TGA for Class 4 IVDs).
- Pay the application fee.
In summary, the new guidelines published by the TGA describe the requirements to be fulfilled for the inclusion of medical devices (including in vitro diagnostic ones) in the Australian Register of Therapeutic Goods. The authority also provides additional clarifications regarding each step of the procedure depending on the class of the medical device in question.
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