Manufacturers of medical devices must ensure their medical devices consistently meet safety, performance, and quality requirements.
Manufacturers of certain medical devices must put in place a formal Quality Management System (QMS) and have the system independently certified.
Key information
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PageLearn about Quality Management Systems and how medical device manufacturers use them to meet their regulatory and customer requirements.
Related information
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PageMedical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.
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PageUnderstand what evidence is needed to have a medical device included in the Australian Register of Therapeutic Goods (ARTG).
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SectionInformation and guidance on the regulation and manufacture of specific types of medical devices.
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PageGain an understanding of commonly identified nonconformities during TGA audits
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