Australia** Commodities Administration (TGA)-registered auditors play a vital role in the medical device registration process. Their responsibilities include, but are not limited to, the following:
Review of application documents: The auditor is responsible for reviewing all documents and materials submitted for the medical device registration application. This includes technical documentation, quality management system documentation, clinical trial data, etc., to ensure that it meets the requirements of Australian regulatory standards and TGA.
Evaluate product safety and efficacy: Auditors need to evaluate aspects such as the design, performance, materials, manufacturing process, and other aspects of a medical device to determine the safety and efficacy of the product. They consider the possible risks and assess whether the risk management plan provided by the applicant is adequate and effective.
Review of the quality management system: The auditor is required to review the quality management system documentation provided by the applicant to ensure that the manufacturing process of the medical device complies with Good Manufacturing Practices (GMP) or other applicable quality standards.
Review of clinical data: For medical devices that require clinical data support, the auditor is responsible for reviewing the clinical trial results or clinical study data submitted by the applicant to evaluate the safety and efficacy of the product.
Communicate with the applicant: The reviewer may need to communicate with the applicant to discuss issues in the application or matters that require further explanation. This may include requesting additional materials or providing additional information.
Decide on registration approval: Based on the review of the application, the auditor needs to make a decision on whether to approve the registration of the medical device. They may make recommendations, but the final decision is usually in the hands of TGA management or committees.
Supervision of registration follow-up: Auditors may also need to participate in the follow-up supervision of registered medical devices, including review of the production process, monitoring of product safety, handling of adverse event reports, etc.
Overall, TGA-registered auditors have an important responsibility to ensure that medical devices comply with Australian regulatory standards and protect public health. They need to have professional technical knowledge and review capabilities, and maintain a fair, transparent and efficient work attitude to ensure that the approval process of registration applications complies with laws, regulations and regulatory requirements.