The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published an official notice on conformity assessment bodies.
According to the notice, starting July 1, 2021, entities based in Australia may apply for designation as an Australian Conformity Assessment Body (AU CAB). Later the regulating authority will publish detailed guidelines describing how such an application should be submitted and outlining the scope of medical devices to be covered by a designation.
- Australian Conformity Assessment Bodies will be allowed to issue conformity assessment certificates for medical devices falling within their scope of designation.
- The TGA as a regulating authority will remain responsible for including medical devices in the Australian Register of Therapeutic Goods (ARTG), the country’s national register of healthcare products, including medical devices, allowed to be marketed and used.
- In order to be eligible for designation as a conformity assessment body, an interested entity shall demonstrate competency and recognition for undertaking medical device conformity assessments and quality management system auditing.
- An interested entity applying for an AU CAB designation should be a company based in Australia and employing the systems and methods recognized by overseas regulating authorities.
The new approach described in the present TGA notice is intended to establish the conformity assessment certification under the applicable Australian legislation. According to the official notice, conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure a medical device complies with the essential principles for medical devices .
The applicable regulation prescribes that any and all medical devices intended to be marketed and used in Australia should be included in the ARTG. For the purpose of inclusion, the medical device manufacturer shall have the necessary evidence confirming that the medical device subject to review has successfully passed the appropriate conformity assessment procedures. The conformity assessment certificate to be provided by the medical device manufacturer should be issued either by the TGA or by a duly designated foreign Notified Body.
The notice also specifies the applicable timeframe – it is stated a conformity assessment to be performed by the regulating authority should take up to 255 days. In order to streamline the review process and also to simplify and accelerate the regulatory procedures associated with placing new medical devices on the market, the applicable legislation has been amended. According to the changes, the TGA is entitled to designate entities to act as notified bodies and carry out conformity assessments within the scope of their designation. However, because this approach has only recently been introduced, additional details of the process are currently under development. As an additional option, the TGA considers the possibility of engaging Notified Bodies designated under the EU regulatory framework.
In terms of additional aspects, the TGA refers to the appropriate guidance documents on manufacturer evidence for medical devices and the medical device inclusion process .
Additional important points are outlined in the Australian regulatory guidelines for medical devices (ARGMD) .
TGA Consultation on Conformity Assessment Bodies
Before the implementation of the new approach, the TGA has conducted public consultations on the matter in order to collect feedback and suggestions from industry representatives and other parties involved. For this purpose, the Australian medical device regulating authority published the appropriate consultation document earlier in November 2016. The document describes in detail the approach suggested by the TGA regarding the way the notified bodies should be designated in order to be allowed to carry out conformity assessment certification of medical devices. The scope of the consultation paper issued by the TGA covers both general and in vitro diagnostic (IVD) medical devices. The new approach is based on the proposal of the Medicine and Medical Devices Review provided in the appropriate report. Under the aforementioned proposal, conformity assessment should be carried out either by the TGA (in the document referred to as the “Australian NRA”) or a body designated by the Australian NRA to undertake Conformity Assessments of medical devices for the Australian market.
Another authority prescribed the adoption of special criteria to be used for evaluating the eligibility of the interested entities applying for designation as conformity assessment bodies. According to these criteria, such entities shall:
- Include capacity to set specific requirements for different classes of medical devices; and
- Be developed in consultation with health care consumers, health professionals, the medical devices industry, and the NRA (i.e., TGA).
New Regulatory Framework in Detail
The consultation paper issued by the TGA further describes the suggested framework and addresses the most important aspects related to the designation of Australian conformity assessment bodies. It is important to mention that the certificates issued by such bodies would be recognized only in Australia. Additionally, the TGA emphasizes the following:
- The general regulatory requirements on conformity assessment of medical devices will remain intact and should be applied irrespectively of whether the TGA itself or a duly designated Australian notified body is conducting the conformity assessment. For instance, medical devices associated with high risk will still be subject to TGA conformity assessment certification.
- If a valid conformity assessment certification is performed by the appropriate notified body, mandatory application audit requirements could be waived.
- The determination of a designation scope should be flexible – conformity assessment bodies applying for designation should be able to apply for a specific scope in terms of classification rules or product groups depending on the resources available (experts, equipment).
- If the medical device manufacturer applies for certification by an Australian notified body and also holds a valid certificate issued by a duly designated European notified body, it could benefit from a reduced assessment. This option is applicable due to the ongoing harmonization of current Australian legislation with the European regulatory framework.
Regarding the last point, the TGA acknowledges that a significant number of medical device manufacturers refer to the conformity assessment performed by notified bodies designated under the EU regulatory framework. According to the document, the share of such applicants constitutes approximately 92 percent. At the same time, in the case of high-risk medical devices, a special exception applies; consequently, a conformity assessment to be carried out by the Australian regulating authority is required.
The consultation paper also describes the reasons behind the new approach suggested by the TGA, namely:
- The need to improve the overall premarket review process and accelerate the procedures related to placing new medical devices on the market.
- Reduce the workload for the TGA with regard to conformity assessment.
- Since the Australian medical devices market is quite small, the country decided to align its legislation with the respective European rules and regulations. For instance, CE mark certification is acceptable in Australia.
In summary, the new approach announced by the TGA allows the engagement of third parties in the conformity assessment process. According to the new framework, Australian entities could be designated to carry out conformity assessments of medical devices intended to be marketed and used in Australia.
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