Through the document Clinical evidence guidelines for Medical Devices published last June, TGA has finally made available the most significant guidelines to allow Manufacturers and Sponsors the collection, drafting and submission of clinical evidence that complies with regulatory requirements and is in line with the requirements of TGA reviewers.
The document, divided into three sections (1. General Requirements, 2. Special Topics, 3. Requirements for Specific device types), provides information on:
- legislative framework, detailing the parts useful for demonstrating the fulfillment of Essential Principles (EPs) and for triggering an appropriate clinical evaluation process, based on clinical investigation, literature review, or both;
- full EP list with particular focus on requirements 1, 2, 3, 4, 6, 13, 13A and 14 (the latter as a general principle related to the clinical evaluation process), especially relevant to demonstrate clinical compliance;
- clinical data and related requirements, outlining key concepts and definitions, describing the clinical evaluation process (which must be kept available and up-to-date throughout the device lifecycle) and related responsibilities;
- sources of clinical data, i.e., clinical investigations, reference literature and field experience (Real World Data), including post-market surveillance. The data collection and analysis processes are explained in the dedicated sections, and the results are evaluated by TGA according to the risk of the device.
- Clinical Evaluation Report (CER), including a description of the structure, form and content. This information, also provided as checklist, also includes the role of critical data analysis and clinical experts’ opinion;
- use of clinical data from substantially equivalent devices and methods to demonstrate such equivalence; in particular, it is specified that the equivalent device does not need to have been registered with the ARTG if it already has marketing authorizations from other recognized Regulatory Authorities;
- requirements for specific device types, such as custom-made devices.
The document is affected by the process of standardization to international requirements of which the TGA is an active participant, although this process is still ongoing. Particularly with regard to clinical evaluation, the regulations are still affected by some peculiarities on a theoretical and documentary level on the presentation of requirements.
Therefore, as strongly recommended by TGA, the document should be considered by Manufacturers as a crucial text for the evaluation of Medical Device marketing strategy in the Australian market.
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