The new article highlights the aspects related to the documentation to be provided by the medical device manufacturer with respect to the product subject to review in terms of its description, as well as testing, verification, validation activities, and conformity to the applicable standards.
The Health Sciences Authority (HSA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to product registration submissions. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance therewith.
At the same time, provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The document describes, inter alia, the content of the submissions and outlines the key elements to be included in order to ensure the completeness and accuracy of the information submitted.
According to the document, it is intended to provide guidance on the submission of a product registration dossier to HSA via the Medocumentation, Information, and Communication System (MEDICS). In particular, the document provides clarifications with respect to specific modules to be used.
Under the general rule, the applications for product registration should be submitted online in electronic format in accordance with the ASEAN Common Submission Dossier Template (CSDT) or in line with the recommendations developed by the International Medical Device Regulators Forum (IMDRF) for general medical devices.
First of all, the document describes the scope of information the authority expects to be included in the submission with respect to the medical device in question. According to the guidance, the submission should include the following elements:
- A comprehensive description of the device, including technology, functionalities, features, and connectivity capabilities (e.g., wireless-enabled, Bluetooth-enabled, internet-connected, and network-connected devices), if applicable. The information should be accompanied by pictures and drawings for illustrative purposes.
- An indication of a risk class and applicable classification rule for the medical device according to the regulations
- Product specifications include the version number of the software, if applicable.
- List of medical device accessories intended to be used in combination with the devices. According to the guidance, the submission should also provide information about accessories that are intended to be used with the device but are supplied separately.
- Should the safety and effectiveness data related to similar medical devices already on the market be used to support claims made by the manufacturer, the applicant is also expected to provide:
- A list of such devices and specific information on the registration status of these devices with HSA (for instance, the appropriate registration numbers);
- A comparison, preferably in a table, of the design, specifications, and intended use/indication for use between the subject device in the current submission and the comparator devices (similar and/or previous generation). As in case of the general description of the device, the authority encourages medical device manufacturers to provide images and other visual elements illustrating the information.
A list of all materials in direct or indirect contact with the patient or use. The authority additionally emphasizes that in the event of specific concerns with respect to the safety of the materials used, the HSA may request additional information be provided by the manufacturer to address such concerns.
Design Verification and Validation
The guidance also outlines the scope of documents to be included in the submission with respect to design verification and validation-related matters. In particular, the documentation to be provided by the applicant should cover such aspects as:
- Preclinical studies (e.g., physical test data, biocompatibility studies, animal studies and software verification and validation studies);
- Metrological requirements;
- Sterilization validation (if applicable).
The authority also expects the applicants to provide comprehensive information about shelf-life studies and the projected useful life of the product in question.
As further explained by the HSA, the documents to be included in the submission should include sufficient evidence supporting the physical or mechanical properties of the product in question, as well as evidence supporting its electrical safety and electromagnetic compatibility. For instance, should the device be supposed to be compliant with the specifications set forth by the applicable international standard, the manufacturer will be expected to provide a summary of the appropriate test reports and/or relevant certificates demonstrating compliance with the said specifications.
The manufacturer should also provide the details on the exact version of the software used for the device subject to review (the authority mentions that the version number used for internal purposes is not required). The manufacturer should also provide a description of any and all verification, validation, and testing activities carried out with respect to the software, including references to the specific version undergoing such testing.
The scope of the information and documentation to be submitted by the applicant should cover, inter alia, the following aspects:
- Any and all anomalies identified in the course of testing that have not been resolved. For each of them, the manufacturer would have to provide an appropriate justification of why they are acceptable and also inform the public of any plans to have the respective issues resolved.
- Studies related to biocompatibility and toxicology. In this respect, the authority additionally emphasizes that if the tests described in the applicable standard, which is ISO 10993, have not been conducted, the appropriate explanation should be provided as well.
- Details on the biological materials or derivatives, including their description and purpose.
In summary, the present HSA guidance describes in detail the scope of information and documentation to be included in the submissions in order to ensure its completeness. The authority outlines specific documents to be provided with respect to the general description of the device, its compliance with the applicable regulatory requirements and standards, as well as any testing it was subject to.
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