![]() ![]() The intended purpose needs to suitable for the device and it must perform in the way intended by the manufacturer. The manufacturer should maintain an active and robust quality management system (QMS) and the application of sound manufacturing practices for evaluating risk and in the design and construction of medical devices. Demonstrating compliance with them establishes that the product is safe and fit for its intended purpose. These Principles relate to safety and performance aspects of the device including its design and construction. Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the Essential Principles. If the manufacturer's labelling, advertising, or documentation contain the claims above, the face mask is considered to be a medical device and is required to be included in the ARTG.Īll classes of medical devices need conformity assessment evidence before they can be manufactured and supplied. The face mask is suitable for therapeutic use such as for surgical, clinical, medical use, or use in other health services.The face mask is to be used for the prevention of the transmission of disease between people, or.More information on regulation of PPE and different types of masks and respirators is provided at Regulation of Personal Protective Equipment and COVID-19.Ī summary of some of this information is available in a guidance video on face masks:įace masks meet the definition of a medical device when the following claims are made: This guidance will be updated periodically to provide further clarity for both manufacturers and sponsors. This information is not exhaustive and not designed to be a checklist for compliance with the Essential Principles. The information provided may be useful to manufacturers and sponsors, as well as health care facilities and health care personnel. This Guidance intends to assist manufacturers in choosing appropriate standards and to set out the TGA's expectations for performance testing of respirators, surgical respirators and medical/surgical facemasks, before inclusion on the ARTG. The TGA has also identified common areas of non-compliance against claimed standards throughout this review process. The TGA is aware there are many different standards available to manufacturers and we are familiar with differences between these standards. The TGA is currently undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). ![]()
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